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Induction Resource for Clinical Research Delivery Staff All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 1 Acknowledgements ............................................................................................................. 4 Useful contacts.................................................................................................................... 4 Introduction ........................................................................................................................ 5 Clinical Research Induction Resource 6 Your Induction..................................................................................................................... 7 Corporate Induction ...................................................................................................................... 7 Local Induction and Objective Setting ........................................................................................... 7 Research Induction ........................................................................................................................ 7 Induction Checklist ........................................................................................................................ 8 Example Induction Programme ..................................................................................................... 8 Reference Section 10 Clinical Research Staff ....................................................................................................... 11 Training for all Clinical Research Staff ................................................................................ 11 Quality Assurance (QA) and Good Clinical Practice ............................................................. 12 Study set up ...................................................................................................................... 12 Health Research Authority (HRA) ....................................................................................... 13 Research Ethics Committees (RECs) .................................................................................... 13 Medicine and Healthcare Products Regulatory Agency (MHRA) .......................................... 14 Research and Innovation Department (R&I) ....................................................................... 14 Local approvals ................................................................................................................. 14 Roles & Responsibilities of Researchers and LTHT ............................................................... 15 Sponsor ........................................................................................................................................ 15 Funder of research ...................................................................................................................... 15 Chief Investigator......................................................................................................................... 15 Principal Investigator ................................................................................................................... 16 Co-Investigator (Medical) ............................................................................................................ 16 Clinical Research Staff e.g. Research Nurse/AHP/Midwife/Clinical Trial Assistant Posts ........... 17 Data Managers/Research Administrators ................................................................................... 17 Research Governance and Good Clinical Practice ................................................................ 18 Safety Reporting ............................................................................................................... 18 Adverse Event (AE) ...................................................................................................................... 18 Serious Adverse Event (SAE) ........................................................................................................ 18 Device deficiency ......................................................................................................................... 19 Adverse Device Effect (ADE) ........................................................................................................ 19 Serious Adverse Device Effect (SADE) ......................................................................................... 19 Serious Adverse Reaction (SAR) .................................................................................................. 19 Suspected Unexpected Serious Adverse Drug Reactions (SUSAR) .............................................. 19 All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 2 Informed Consent .............................................................................................................. 20 Performance in Clinical Research ....................................................................................... 22 Initiation ...................................................................................................................................... 22 Delivery ........................................................................................................................................ 23 Clinical Research Forum ..................................................................................................... 23 Further useful information ................................................................................................. 24 Trial design................................................................................................................................... 24 Human Tissue Act ........................................................................................................................ 25 Data Protection............................................................................................................................ 25 UK Clinical Trials Gateway ........................................................................................................... 26 Clinical Trials.gov ......................................................................................................................... 26 CLARHCs (Collaborations for Leadership in Applied Health Research and Care) ........................ 26 Clinical trials tool kit .................................................................................................................... 27 AHSN (Academic Health Science Networks) ............................................................................... 27 Study Management - Essential documents for the Conduct of a Clinical Trial ....................... 28 Trial Master File (TMF) ................................................................................................................ 28 Case Report Form (CRF) completion ........................................................................................... 28 Source documentation ................................................................................................................ 29 Appendix Printable Resources 30 Appendix I - Induction checklist .......................................................................................... 31 Appendix II - Induction Resource Registration Form ............................................................ 32 Appendix III- Research CV Template ................................................................................... 33 Appendix IV - Example Training File ................................................................................... 35 Appendix V - Research acronyms ....................................................................................... 37 Appendix VI - Glossary ....................................................................................................... 42 Appendix VII - Evaluation Form .......................................................................................... 49 All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 3 Acknowledgements The following were members of the Induction Resource working group: Julie Bailey Debbie Beirne Tracey Crowther Sally Redfern Suzanne Rogerson Senior Research Nurse, Leeds Teaching Hospitals (LTHT) National Institute for Health Research (NIHR) Leeds Clinical Research Facility Manager, LTHT Research Nurse, LTHT Research Nurse, LTHT Research Nurse, LTHT This document has been reviewed through members of the Clinical Research Forum and the working group would like to thank the following people: Heather Iles-Smith Helen Radford Karl Ward Donna Johnstone Elizabeth Wright Samantha Cassidy Head of Nursing - Research and Innovation (R&I) Neurosciences Clinical Trials Manager Neurosciences Research Team Leader & NIHR Clinical Research Network (CRN) and Good Clinical Practice (GCP) Facilitator Research and Innovation Manager Senior Research Nurse Diabetes/Endocrinology Clinical Trials Assistant Useful contacts Research & Innovation Department T 0113 39 22878 F 0113 39 26397 http://www.leedsth.nhs.uk/research NIHR Clinical Research Network CRN: Yorkshire and Humber (YH) Sheffield Teaching Hospitals NHS Foundation Trust, Chief Executive Office, 8 Beech Hill Road, Sheffield, S10 2SB https://www.crn.nihr.ac.uk/ Debbie Beirne Leeds CRF Manager - Deputy Director [email protected] - [email protected] http://leedscrf.nihr.ac.uk Heather Iles-Smith Head of Nursing - Research and Innovation [email protected] This is an iterative document and links/advice may change. Please consult the R&I website or team for advice as appropriate in the first instance. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 4 Introduction Congratulations and welcome to your new role in clinical research. Our ambition at LTHT is to be a global leader in clinical research and innovation which is translated into patient benefit at pace and scale. The health research arena in LTHT and The University of Leeds is a dynamic and diverse one in which multiple disciplines and professions work collegiately and in partnership to deliver world class research for patient benefit. Clinical research in Leeds is increasing and in parallel the number of research staff with varying levels of experience is also growing. There are strong and established areas of research activity, some of which is world-leading, focused around our NIHR Leeds Clinical Research Facility in cancer, musculo-skeletal diseases and cardiovascular research. There are also many more speciality areas of very high quality research across the organisation, for example, in surgery, diabetes, paediatrics, dental, urology, midwifery, chronic pain, epidemiology, infectious diseases and genetics. There is a wealth of non-interventional research on-going across the University and Trust in imaging, epidemiology, genetics, psychology and other areas of health science. You are therefore joining a community of colleagues whose goal is to improve the health outcomes for patients and the public by means of high quality research to deliver effective prevention, earlier detection, improved diagnostics, enhanced treatment techniques and novel therapeutics. This drives our professional focus and commitment to delivering high quality, robustly evidenced health research. Starting in a new role in research can be daunting, and you may find that whatever prior experience you come with does not seem of use, or where you once felt competent you now feel a novice again. This is a common experience for many and it is important to remind yourself that your skills and knowledge are extremely valuable to this role, but that there is also great scope and opportunities to learn and develop new skills. Allow yourself the time to do so without undue pressure. A career in health related clinical research can be personally, intellectually and professionally very rewarding. At the heart of a research role is patient care and advocacy. Research involving unlicensed medicinal products, invasive interventional studies and early phase clinical trials can be particularly challenging to deliver and therefore require research staff to be flexible, innovative, proactive and committed to successfully recruit and safely care for patients, and deliver the quality data required to inform and influence future practice. We hope you find the information and guidance in this handbook a useful first reference point in your induction and start of your research career. It is important that you feel supported and we recommend that you make the most of any opportunities to network with other colleagues in other areas. The Clinical Research Forum which is open to all research staff offers this support network. The forum meets regularly and exists to offer peer support, facilitate knowledge transfer and provide education and training in order to retain an expert clinical research workforce within LTHT and facilitate high quality research for the benefit of patients. It is imperative that wherever possible research nurses and Allied All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 5 Health Professionals (AHP’s) do not work in isolation, if you are a lone worker in a particular area please seek support and guidance from other experienced research colleagues. Wishing you every success in your post. Clinical Research Induction Resource This Induction Resource includes guidance to ensure that you and your line manager can; Plan a comprehensive induction programme Gain an understanding of the training available and knowledge needed to work in research It is designed to give you the information you need at the beginning of your research post within LTHT and aims to be a comprehensive resource which you can refer back to throughout your career. It is intended to be used as an electronic, accessible document which you should save to your preferred folder. However, there are specific pages housed in the appendices that can be printed for your personal training folder. The resource should form a foundation to your learning and give you the opportunity to reflect upon this and signpost you to external resources of further information, as your knowledge increases. The most important elements of your role are to provide a high standard of patient care and safety for those immediately caring for patients directly and to collect robust, high quality data to ensure protocol adherence and maintain the integrity of the study. The safety of patients remains as important as it would in a non-research role and poor data quality can affect the outcome of the entire study. An evaluation form has been designed to gather feedback on this revised resource. We would appreciate it if this could be completed and returned when your induction is complete, to allow us to make future alterations. This can be found in Appendix VII. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 6 Your Induction There are 3 elements to this, the Trust Corporate Induction, the Trust Local Induction and your Research Induction specific to the area you will be working in. Corporate Induction All new permanent staff members must attend Corporate Induction during the first week of appointment. Local Induction and completion of checklists is mandatory for all staff. Corporate Induction training dates are available on the Trust intranet: http://lthweb/sites/organisational-learning-1/corporate-induction/corporate-induction Local Induction and Objective Setting It is a mandatory requirement of the Trust that both you and your manager/supervisor participate in Local Induction and that you complete Local Induction in the required time period. Completion of this will set your objectives for the coming year and ensure that your appraisal is up to date. Your next appraisal will take place in the following appraisal season (April, May & June). Local induction checklist and objectives can be accessed through http://lthweb/sites/organisational-learning-1/appraisal-training/appraisal-training Link to local Induction checklist and information on how to access the training calendar: http://lthweb/sites/organisational-learning-1/corporateinduction/20160205%20Local%20Induction%20Paperwork%20-%20Final.pdf Research Induction It is important that you meet with your Line Manager to discuss the scope of your role and nature of the work within your speciality, your previous experience and ensure your Induction Programme covers all aspects of your role. It could include the following: Familiarisation with data protection legislation and institutional policies Internal governance procedures and quality assurance Understanding the roles of Research Ethics Committees (RECs) and R&I, and the statutory legislation for research governance Understanding of research methods How to describe randomisation and clinical equipoise to potential subjects Other trial related procedures, clinical and non-clinical Shadowing colleagues in clinical areas and for peer learning re research trial conduct Introduction to blood sample collection, handling, processing and shipment Dry ice handling and legislation/guidance NHS.net email accessed through https://web.nhs.net All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 7 Patient Pathway Management (PPM) training access via http://lthweb/sites/ittraining/ppm PAS/Patient Centre access classroom course accessed through http://lthweb/sites/it-training/pas-training/patient-administration-training-system IT helpdesk telephone 26655 or email informatics on [email protected] Access to online stock ordering http://lthweb.leedsth.nhs.uk/@@search?SearchableText=iproc EDGE: clinical research management system for entering real-time trial activity https://www.edge.nhs.uk/Account/Index?ReturnUrl=%2f Organisational learning Leeds TH NHS Access to relevant network drives Timesheets/off duty GCP training https://learn.nihr.ac.uk/course/index.php?categoryid=5 AVA http://trustalk/directory/ Fax/photocopier/scanner Introduction to key staff: Relevant consultants and wider medical team Matron (or appropriate AHP line manager) Clinical Service Unit (CSU) manager/faculty or R&I lead at University R&I lead for specialty Business Manager Nursing and other local research colleagues Outpatient or other patient areas to be utilised when conducting research Administrative team and or wider research support staff as appropriate/available to you Induction Checklist An induction checklist has been provided for completion during your research induction which can be found in Appendix I and printed out for inclusion in your training file. Example Induction Programme It is your responsibility as well as your line manager to ensure that you have completed both corporate and local inductions and agreed a comprehensive induction programme during the first month in post. This will be defined by the department you are based in and your previous experience, and therefore will need to be developed as part of your review. Please see the next page for an example induction programme. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 8 MONDAY W E E K 1 W E E K 2 W E E K 3 W E E K 4 TUESDAY WEDNESDAY THURSDAY FRIDAY DATE: DATE: DATE: DATE: DATE: AM AM AM AM AM Corporate Induction Corporate Induction Corporate Induction Corporate Induction Corporate Induction PM PM PM PM PM Corporate Induction Corporate Induction Corporate Induction Corporate Induction Corporate Induction DATE: DATE: DATE: DATE: DATE: AM AM AM AM AM Introduction to research team Meet with PI Study training with research colleagues Visit CTRU Study training with research colleagues PM PM PM PM PM Local induction with line manager DATE: Visit by study monitor Follow-up visits/recruiting Meet with ethics Follow-up visits/recruiting DATE: DATE: DATE: DATE: AM AM AM AM AM Visit R&I GCP training Study specific training i.e. sampling handling Study training with research colleagues Study training with research colleagues PM PM PM PM PM R&I GCP training Follow-up visits/recruiting Follow-up visits/recruiting DATE: DATE: Study specific training i.e. pharmacy visit DATE: DATE: DATE: AM AM AM AM AM Time with associated CSU Time with associated CSU Induction book work Study specific training i.e. equipment training Study training with research colleagues PM PM PM PM PM Time with associated CSU Time with associated CSU Standard Operating Procedure (SOP) training Follow-ups/recruiting Induction book work All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 9 Induction Resource for Clinical Research Delivery Staff Reference Section All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 10 Clinical Research Staff As a Clinical Research Professional you will be providing specialist care that will have a potential benefit to your patients as well as a benefit to future patients. The role of Clinical Research staff is diverse, covers many specialties and is increasingly becoming recognised as a specialty in its own right. It can be a challenging role but is an opportunity to use the skills you have gained in clinical practice, combined with new research skills that you will acquire that will establish your career as a clinical research professional. You will be responsible for ensuring that your clinical trials are completed according to the study protocol, that you perform any tasks which are delegated to you to a high standard and that you have sufficient experience and training to complete these tasks. Training for all Clinical Research Staff To record your professional development and to support the duties you are undertaking within your studies it will be useful to set up a Training Folder (recommended example inserts can be found in Appendix IV). This will demonstrate the experience you gain and training you complete as you progress through your career in research. This should include a research CV (see Appendix III), copies of your GCP Certificate and Informed Consent training and a copy of your current job description. Good Clinical Practice (GCP) Training In order to achieve your goals of patient safety, data quality and to adhere to legislative requirements and research governance guidelines you will be required to complete GCP training. GCP training is mandatory for anyone working in clinical research. If you have not completed this training before it is something that you will need to undertake as a priority during the first month in post. The Trust http://www.leedsth.nhs.uk/research/information-forresearchers/training/ recommends GCP training should be undertaken as an online course or a full day classroom-based course (NIHR Introduction to GCP). It is available several times per year within the Trust, University of Leeds and through Yorkshire and Humber Clinical Research Network. You may find it helpful to complete an online course (which usually takes 3-4 hours) as soon as you can, https://learn.nihr.ac.uk/course/index.php?categoryid=5 followed by a full day course within the first 6-12 months in post. Yorkshire and Humber Cancer Research Network offers a programme of training courses for clinical researchers who are both experienced and new to research. GCP training updates should then be completed every two years. Details of these courses funded by the YH CRN can be found on their website: https://learn.nihr.ac.uk/ All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 11 Quality Assurance (QA) and Good Clinical Practice Quality Assurance is an important component of every clinical research post, as all our activities in delivering research to a high standard contribute to the QA process. Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected. All organisations involved in clinical trials must have a quality management system in place to support the clinical trial activities they conduct. This ensures that the trial is performed in compliance with GCP and other applicable regulatory requirements and the data generated is reliable and accurately reported. Essential features of a quality management system include: Clearly documented written standard operating procedures (SOPs) which allow a consistent approach to trial activities Adequate training of staff (induction and continuous) Dedication to continuously improve standards through reporting, correcting and reviewing all events which involve non-compliance of guidelines, recommended practice or SOPs Using equipment and materials that can be verified as suitably calibrated and fit for purpose. Document control procedures which allow traceability of records and ensure accurate version control. A programme of annual internal audit to assess compliance with guidelines, recommended practice or SOPs and provide confidence that quality assurance requirements are being fulfilled. Study set up Before a research study can proceed at LTHT the Principal Investigator (PI)/Research team is required to complete capacity and capability (feasibility) assessment of the potential new study, which includes; PI/Research team completes the capacity and capability assessment form PI presents capacity and capability assessment for CSU review to either the CSU Research Group/CSU Clinical Director/CSU Research Lead PI/Research team contacts all departments that the study will impact on so they can provide written assurance that they can support the study before submission to R&I PI submits completed capacity and capability assessment form indicating CSU approval to R&I at [email protected], prior to proceeding with study set up *CSU approval of studies should only be given once the capacity and capability assessment has been completed. The CSU you work in may require a capacity and capability form to be completed to enable the feasibility review. Please check with the R&I Lead. For more information about study capacity and capability see ‘Research Capacity and Capability Guidance’ LTHT-guidance-for-researchers-on-new-study-confirmation-process-v7 All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 12 There are several organisations and departments involved in the initial study set up, some of which are listed below, others can be found via this link http://www.leedsth.nhs.uk/research/information-for-researchers/getting-started-on-a-study/. Researchers and sponsors have an obligation to follow the agreed protocol and collect the agreed data. The outcome will be a robust data set answering a relevant medical question. Further information on conducting clinical research can also be found at Governance and Good Clinical Practice Health Research Authority (HRA) http://www.hra.nhs.uk/ The HRA is a national body that is implementing a new national research approval process to make it simpler and easier to do research in the NHS. HRA Approval is the new approval that is now required for research to commence in the NHS in England. It comprises an assessment of study compliance with applicable regulations and standards and includes review by an NHS research ethics committee. It allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study within their organisation. HRA approval is mandatory for all new studies. Research Ethics Committees (RECs) http://www.nres.nhs.uk/ Research Ethics Committees (RECs) are the committees convened to provide independent advice to participants, researchers, funders, sponsors, employers, care organisations and professionals on the extent to which proposals for research studies comply with recognised ethical standards. The purpose of a REC in reviewing the proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research participants. Ethical advice from the appropriate NHS REC is required for any research proposal involving: Patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient or user’s past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions. Individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above. Access to data, organs or other bodily material of past and present NHS patients. Foetal material and IVF involving NHS patients. The recently dead in NHS premises. The use of, or potential access to, NHS premises or facilities. NHS staff – recruited as research participants by virtue of their professional role. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 13 Medicine and Healthcare Products Regulatory Agency (MHRA) https://www.gov.uk/government/organisations/medicines-and-healthcare-productsregulatory-agency You may need approval from the MHRA, The Medicines and Healthcare products Regulatory Agency. This body regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health. More information can be found by clicking on the link above. Research and Innovation Department (R&I) http://www.leedsth.nhs.uk/research The R&I Department support and facilitate researchers to undertake high quality research, and provide research governance to ensure the interests of participants, researchers and the Trust are protected through adherence to the local and national regulatory frameworks. They have a responsibility to make sure all the legal requirements have been met before research starts. The hyperlink above leads you to their intranet pages which have a wealth of information for research staff about conducting clinical research. Local approvals Depending on the type of clinical trial you are working on you will need to gain various local approvals from departments such as: Radiology http://www.leedsth.nhs.uk/assets/Uploads/Radiology-Guidance-forResearchers.doc Pharmacy http://www.leedsth.nhs.uk/assets/Uploads/Pharmacy-Request-for-reviewV4-July-2012.doc Finance http://www.leedsth.nhs.uk/assets/Uploads/Standard-financialinstructions.pdf Finance lead staff details can be found on the R&I contact us page. Medical physics: if investigating a medical device. If it is a new medical device you will also need to submit details to the New Implantable Medical Device group. http://thehub.leedsth.nhs.uk/Documents/PoliciesandProcedure/New Interventional Procedure - Procedures New to the Trust.doc Laboratory http://www.pathology.leedsth.nhs.uk/Pathology/ Research Histopathology Assessment Form http://www.leedsth.nhs.uk/assets/Uploads/ResearchHistopathology-Assessment-Form-03.07.14.docx Clinical Support Unit (CSU) http://www.leedsth.nhs.uk/assets/Uploads/27-1-16-v1-6Draft-Capacity-and-Capability-Assessment-Form-CS.pdf Please check with the CSU R&I Lead. Contact details of key staff who can grant approvals can be found at: http://www.leedsth.nhs.uk/research/information-for-researchers/getting-started-on-a-study/ All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 14 Roles & Responsibilities of Researchers and LTHT To be successful specific tasks within a trial need to be delegated appropriately from the sponsor to various members within the trial team. Sponsor All clinical trials and studies: The Sponsor is responsible for ensuring expert scientific and ethics reviews are carried out. Puts in place arrangements to adhere to GCP (if no other person is specified) and ensures arrangements are in place to be alerted to significant developments. Takes appropriate urgent safety measures (with Investigator). Ensures arrangements are in place for compensation (indemnity/insurance arrangements). Keeps records of all adverse events reported by Investigators. Ensures the Research Ethics Committee is notified when the trial has ended. Clinical Trials involving investigational medicinal products (CTIMP): Ensures the EudraCT (European Clinical Trials Database) Number is obtained. Competent Authority Authorisation is obtained (Chief Investigator). Pharmacovigilance reporting and time frames are adhered to. EudraCT and the Competent Authority are notified when trial has ended. Funder of research Ensures quality and value for money, based on research costs and any care or treatment costs and makes arrangements for independent expert review. Ensures funding is conditional on identifying a sponsor (usually a university or National Health Service (NHS) Trust). Provides assistance to any enquiry, audit or investigation of the funded work. Chief Investigator Is responsible for the design, management and reporting of the study for all sites. Is responsible for ensuring that each Investigator is aware of their legal duties and obligations. Is responsible for ensuring the protocol is approved by relevant bodies, any preconditions are acted upon, and that research follows the agreed protocol except in the case of urgent safety measures. Undertakes duties delegated by the sponsor (usually working in conjunction with a Clinical Research Organisation (CRO) if it is a pharmaceutically funded trial). All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 15 Publishes the clinical study results as soon as possible following study completion. In a multi-centre study, the chief Investigator must ensure that the data from one centre is not published before the publication of the whole study without his/her consent, and must obtain Sponsor approval prior to publication. http://www.leedsth.nhs.uk/assets/Uploads/RG-CI-and-PI-info-v2-011214.pdf Principal Investigator If the trial is being conducted at multiple sites, there will be a designated Principal Investigator who is responsible for the day to day running of the research study at an individual site. It is the responsibility of the Principal Investigator to ensure that the study is conducted in accordance with the Research Governance Framework for Health and Social Care, International Conference on Harmonisation (ICH) GCP, the terms of the Health Research Authority approval and Leeds Teaching Hospitals NHS Trust policies and procedures. Please refer to the Principal Investigator guidance section on the R&I website. Co-Investigator (Medical) The Co-Investigator is responsible for medical care of patients participating in research studies, working under the supervision of the Principle Investigator. The Co-Investigator is usually delegated the following responsibilities: To ensure that the study is performed in accordance with ICH-GCP, all local laws and regulations concerning clinical studies. To confirm subject eligibility according to the inclusion/exclusion criteria stated in the protocol. To obtain and record patient consent. To withdraw a subject from the clinical trial for any reason should this be thought to be in their best interest. To perform protocol directed medical care including assessment, examination and prescription of study and support medication. To ensure subject anonymity is maintained. To ensure the completeness and accuracy of case report forms. To agree to allow the monitor/auditor/inspector to have access to any or all of the study materials needed for source data verification and review of study progress. To retain all essential documents as per NHS and Trust guidelines (usually a minimum of five years following the end of a study, at least two years after the approval of a marketing application, for a new drug, or longer if required by the regulator requirements). To comply with the study sponsor and regulatory authority requirements regarding the auditing of the study http://www.leedsth.nhs.uk/assets/Uploads/RG-Drs-info-v3-011214.pdf All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 16 Clinical Research Staff e.g. Research Nurse/AHP/Midwife/Clinical Trial Assistant Posts The research staff are delegated responsibilities by the PI, these may include; Preparing and submitting local regulatory approval applications. Ensuring that they have attended an initiation meeting and received any appropriate training prior to the trial commencement. Co-ordinating the clinical trial in terms of patient screening, recruitment, entry into the trial via randomisation if applicable and subsequent patient visits. Checking patient eligibility according to the inclusion/exclusion criteria stated in the protocol in collaboration with medical staff. Collaborating with clinicians to assess patients and making treatment decisions according to the protocol. Delivery of investigational agents/treatments and protocol directed care. Handling, spinning, labelling, storage and shipping of blood, urine or other human samples for pharmacokinetic, pharmacodynamics and pharmacogenomics analysis. Ensuring that source documentation is a true reflection of decisions and actions taken for each individual patient. Completion of case report forms and ensuring relevant follow up data is collected (e.g. Quality of Life (QoL) data). Monitoring and reporting all safety events: Serious Adverse Events SAEs, Serious Adverse Device Effect (SADEs), Serious Adverse Reactions (SARs), Suspected Unexpected Serious Adverse drug Reaction (SUSARs) as outlined in the protocol, including prompt reporting to Sponsor to ensure further communication with MHRA/REC if applicable within the statutory timelines. Liaising with the study sponsor regarding the conduct of the trial. Educating patients/subjects and dissemination of trial related information to staff. Data Managers/Research Administrators Non-clinical research support staff work closely with the research team to ensure accurate and appropriate data collection. Their delegated responsibilities may include; Ensuring that they have attended a site initiation meeting and received any appropriate training necessary in order to conduct the trial safely and efficiently. Assisting in the attainment of quality of life and other study evaluation forms. Entering subjects into clinical trials, utilising appropriate randomisation procedures when necessary. Completing case report forms and other research records. Close liaison with industry partners to support monitoring visits, ensuring that all data is prepared and available. Assisting with or completing submissions to Ethics/Research and Development. Archiving all clinical trial related documents according to regulatory requirements. Shipping human tissue samples to central laboratories. Entering data and updating fields/information within databases. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 17 Research Governance and Good Clinical Practice Any one working on a research trial in LTHT should be working to the standards of Good Clinical Practice described in the Research Governance Framework (2005) https://www.gov.uk/government/publications/research-governance-framework-for-healthand-social-care-second-edition and if you are working on a drug trial as described in UK law in the Medicines for Human Use (Clinical Trials) Regulation SI:1031 2004 and subsequent amendments http://www.legislation.gov.uk/uksi/2004/1031/contents/made. Further information about governance and good clinical practice can be found at http://www.leedsth.nhs.uk/research/information-for-researchers/governance-and-goodclinical-practice/ Throughout the duration of a clinical trial, data is collected to monitor the effects of the study and any interventions on the participants, to ensure their safety to report any effects to protect patients during the study; this is known as pharmacovigilance, (the recording and reporting of adverse events and reactions to medicinal products being used in a clinical trial). This information is collected and reviewed to assess the risk/benefit ratio of any new treatments, or practices, used in a study and once it becomes standard care. For example, the information leaflet that accompanies any medicines (giving information about the medication and any possible side effects) has been produced from the safety information gathered during and after the licensing of the drug. LTHT has developed a standard operating procedure for pharmacovigilance which can found at: http://www.leedsth.nhs.uk/assets/Uploads/QCRES-01-Researchers-Pharmacovigilance-v1-1160225.pdf Safety Reporting Effects of study medication or interventions are recorded in the following categories: Adverse Event (AE) An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The study protocol will specify whether it should be recorded on the CRF or not. Serious Adverse Event (SAE) A serious adverse event is an adverse event that: results in death is life-threatening requires in-patient hospitalisation or prolongation of existing hospitalisation results in persistent or significant disability or incapacity is a congenital anomaly or birth defect following maternal or paternal exposure All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 18 An event specified in the protocol as needing to be reported as serious should be reported by fax to the sponsor within 24 hours of knowledge of event. This includes device deficiencies that might have led to a serious adverse event if a) suitable action had not been taken or b) intervention had not been made or c) if circumstances had been less fortunate. Device deficiency Inadequacy of a medical device related to its identity, quality, durability, reliability, safety or performance, such as malfunction, misuse or use error and inadequate labelling. Further information can found in Clinical investigation of medical devices for human subjects -- Good clinical practice (ISO 14155:2011) Adverse Device Effect (ADE) Adverse event related to the use of an investigational medical device. This includes any adverse event resulting from insufficiencies or inadequacies in the instructions for use, the deployment, the implantation, the installation, the operation, or any malfunction of the investigational medical device. This includes any event that is a result of a use error or intentional misuse. Serious Adverse Device Effect (SADE) An adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event. Serious Adverse Reaction (SAR) A Serious Adverse Reaction is an event that is classed as serious and is consistent with the information provided about the Investigational Medicinal Product. An SAR must be recorded in the Case Report Form (CRF) and reported annually to ethics and regulatory authorities. Suspected Unexpected Serious Adverse Drug Reactions (SUSAR) If the nature, severity, frequency or outcome of the event is not consistent with the Investigational Medicinal Product (IMP) information it is classed as a Suspected Unexpected Serious Adverse Drug Reaction. All SUSARS must be expedited to main REC and MHRA. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 19 Informed Consent Within the context of clinical trials, valid informed consent may be regarded as: The process by which a subject voluntarily confirms his/her willingness to participate in a particular clinical trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. It is morally and professionally unacceptable to perform any research related procedure on someone without first obtaining their fully (valid) informed consent. The issue of valid informed consent has prompted great discussion and thought, and really is a key issue in clinical research. Informed consent should be obtained from subjects prior to any research related procedure being performed. Consent is a continuous process, not a one off event. Amendments or safety updates to a study protocol and patient information will require re-consent of the patient/subject. Verbal consent during a study and attendance at scheduled visits implies continued consent. To ensure valid informed consent is obtained the following must apply; A designated Research Ethics Committee must have approved the consent process and documentation for a particular study. Informed consent form must be up to date and revised if new information becomes available (must be re-approved by ethics committee if changed). There must be no coercion of subjects to participate. Language of informed consent should be understandable and not cause subject to waive or appear to waive or release Investigator, institution or sponsor from responsibilities. Inform subject of important information, including risks and side effects. Language should be as non-technical as possible. Allow subject time to review information before signing. Allow time to answer questions and review issues raised by subject. Consent form to be signed and dated by subject and person obtaining consent. Subject must keep signed copy of consent. Subject’s legal rights must be maintained. It is essential to remember that even once a subject has signed an informed consent form, they can withdraw from the trial at any time. It is the duty of the Investigator to reiterate this and reassure them that they will not compromise their future medical care if they decide to withdraw. The issue of who should take consent has been debated at length. The guidance of the key GCP documents, although helpful, is not clear. The Declaration of Helsinki states: All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 20 In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that they are at liberty to abstain from participation in the study at any time. The Physician should then obtain the subjects freely given informed consent, preferably in writing. The Health Research Authority has revised the previous National Research Ethics Service guidance on the design of consent forms into an online format. The online version is now the definitive version of this guidance. At LTHT taking consent for observational studies may be delegated by the PI to other members of the research team following a risk assessment and the study being deemed low risk. It is important that registered healthcare staff (e.g. nurses, midwives and AHP’s) ensure that they have sufficient training to enable them to safely take consent for clinical trials. Yorkshire and Humber CRN currently have a consent training course that may be accessed. Additionally a competency assessment should be undertaken by the line manager. For CTA’s who feel able and comfortable in taking consent a consent training course, provided by the trust, should be attended and a competency assessment undertaken by the Line Manager. A register is also kept by the Lead Nurse for Research regarding CTA’s who have received training and a competency assessment. In the case of CTIMP’s, or medium/high risk device studies, currently only medical staff may take consent. In an exceptional case when the PI/research team feel that it may be appropriate for another member of the team to take consent, the matter should be discussed with the Lead Nurse for Research. Please contact the R&I department to be put in touch with the Lead Nurse. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 21 Performance in Clinical Research The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical research. The aim is to increase the number of patients who have the opportunity to participate in research and to enhance the nation’s attractiveness as a host for research. The Trust has to submit quarterly reports to the Department of Health setting out our clinical research performance. LTHT clinical trial performance is measured against 2 national benchmarks to improve the initiation and delivery of all clinical trials approved by the Trust. • Initiation: the start of the initiation which is 70 days from “Date Site Selected” (i.e. from the date of provision of the local information pack from the sponsor including the HRA Initial Assessment Letter to recruitment of first patient). It is therefore really important that you alert R&I to any new study as early as possible. Once the “Date site Selected” has happened an email will be sent notifying the research team of the date the metric clock started and the date the first patient needs to be recruited by. • Delivery: for all commercial clinical trials hosted by the Trust the agreed number of patients must be recruited within the agreed recruitment period. Initiation Providers of NHS services are required to publish the following information for Initiating Clinical Research (i.e. the 70-day benchmark) on a publicly available part of their website: • • • • • The name of the trial The Research Ethics Committee reference number The date of receipt of a Valid Research Application The date of the recruitment of first patient Where the benchmark has not been achieved for a particular clinical trial, the reason for not doing so. Further information can also be found via the Trust intranet: http://www.leedsth.nhs.uk/research/performance-in-clinical-research/ http://www.leedsth.nhs.uk/assets/Uploads/PID-researcher-comms2.docx Details of what the information pack mentioned above contains can be found here; http://www.leedsth.nhs.uk/assets/Uploads/LTHT-guidance-for-researchers-on-new-researchstudy-confirmation-process-v7-04082016.pdf All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 22 Delivery We are also required to submit data regarding recruitment of patients to ensure the agreed number of patients are being recruited within the defined recruitment period, also referred to as ‘recruiting to time and target’. Presently this is submitted via the NIHR Hub for studies on the NIHR portfolio. You will be required to create an account to log this data which can be found on the internet via the Central Portfolio Management System (CPMS). LTHT will soon be moving to using a new platform for reporting recruitment called EDGE which can be found following this link to Clinical Research Management System: https://www.edge.nhs.uk/Account/Index?ReturnUrl=%2f Until this goes live and the two systems are fully integrated data will be required to be uploaded to both systems. Clinical Research Forum The forum exists to offer peer support, facilitate knowledge transfer and provide education and training in order to retain an expert clinical research workforce and facilitate high quality research for the benefit of patients. Further detailed information about the LTHT Clinical Research Forum can be found at http://www.leedsth.nhs.uk/research/clinical-researchforum/ The Forum invites all staff who are actively involved in clinical research to regularly attend the meetings. The meetings are a great opportunity to network, challenge current ways of thinking, receive updates and encourage involvement in research and innovation. The meeting venue alternates between St James University Hospital and LGI, R&I can provide details on meeting dates. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 23 Further useful information Trial design There are different phases of trial design which are detailed in the table: Phases of Clinical Trials Early Phase/Phase I Trials Phase 1 trials are the first test of a drug, device or procedure in humans; this typically involves a small number of participants in a gradual step wise approach, entering patients into cohorts, with careful assessment and evaluation before enrolling further subjects. The main aim of such studies can be to establish the safety profile, drug metabolism, disposition and tolerability in human subjects, building on existing preclinical data. Phase II Trials Phase 2 trials aim to provide further safety information, adverse event management and information on drug activity (efficacy), devices or procedures. These trials are normally used to determine dose regimens and obtain further safety data in a larger number of patients. Phase III Trials Phase 3 trials are usually large scale comparative studies to look at the risks, benefits and side effects of a drug, device or procedure compared to or in combination with other drugs or placebo, devices or procedures. Phase IV Trials Phase 4 trials take place once the drug, device or procedure has been shown to be effective and has been granted a licence. These trials aim to find out how well the drug, device or procedure works when used more widely than in clinical trials, the long term risks and benefits and gain more information on the possible side effects and safety. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 24 Human Tissue Act The Human Tissue Authority is an independent watchdog that protects public confidence by licensing and inspecting organisations that store and use tissue for purposes such as: teaching about or studying the human body carrying out post-mortem examinations using human tissue to treat patients carrying out research on human tissue displaying human bodies or tissue in public (e.g. in a museum) Taken from Human Tissue Authority website – www.hta.gov.uk for further information please refer to the R&I website http://www.leedsth.nhs.uk/research Data Protection Anyone processing personal data must comply with the eight enforceable principles of good practice. Data must be: Fairly and lawfully processed Processed for limited purposes Adequate, relevant and not excessive Accurate Not kept longer than necessary Process in accordance with the subject’s rights Secure Not transferred to countries without adequate protection Personal data covers both facts and opinions about the individual. It also includes information regarding the intentions of the data controller towards the individual, although in some limited circumstances exemptions will apply. With processing, the definition is far wider than before. For example, it incorporates the concepts of obtaining, holding and disclosing. The nature of research means that there is a large amount of paper and electronic data held about research subjects. All staff involved in research has a responsibility to their research subjects and their employer regarding data protection. All subject data should be stored in a secure room All subject data must be locked away if unattended No one should access subject data unless authorised to do so by research personnel and/or data protection officer Subject confidentiality should be maintained by use of initials/numbers of on research material Electronic data must be password protected in accordance with the Computer Security Policy Personal data that has the potential to identify research subjects should be kept in a secure place. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 25 Any concerns relating to data protection issues must be discussed with the departmental data protection officer. All data should be stored in accordance with local NHS Trust policy. LTHT Data Protection Policy can be accessed on the Trust Intranet: http://thehub.leedsth.nhs.uk/search/pages/Results.aspx?k=Data%20protection&s=All%20Site UK Clinical Trials Gateway The UK Clinical Trials Gateway (UKCTG) https://www.ukctg.nihr.ac.uk brings together information about current health research trials from a variety of sources which can then be searched to find out more about the trials that are taking place. The Gateway provides easy to understand information about clinical research trials running in the UK, and gives you and others access to a large range of information about these trials. It is designed to enable you and your clinician to locate and contact trials of interest to you. The information is being taken from a variety of national registers that are publicly available. This means that it can include trials that may be run from other countries but which have part of the study taking place in the UK. The UKCTG has been established by the NIHR on behalf of all the UK Health Departments and with the assistance of a number of clinical research charities, research professionals and patient representatives. It fulfils the Government's commitment in the Plan for Growth, published by HM Treasury in March 2011, that the Government will open up information about clinical trials to enable the public to get involved and so that patients can find out about clinical trials that may be relevant to their condition. Clinical Trials.gov ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. CLARHCs (Collaborations for Leadership in Applied Health Research and Care) http://www.clahrcpp.co.uk/ National Institute for Health Research (NIHR) Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) bring together a collaboration of the local providers of NHS services and NHS commissioners, universities, other relevant local organisations and the relevant Academic Health Science Network. View more information on the NIHR website https://www.crn.nihr.ac.uk/yorkshire-and-humber/ All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 26 Clinical trials tool kit The Clinical Trials Toolkit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. Through the use of an interactive route map, this site provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials. AHSN (Academic Health Science Networks) http://www.ahsnnetwork.com/ The two key objectives of the Networks are to improve health and generate economic growth. They do this through connecting academics, NHS, researchers and industry to accelerate the process of innovation and facilitate the adoption and spread of innovative ideas and technologies across large populations. AHSNs are catalysts and facilitators of change across whole health and social care economies, with a clear focus on improving outcomes for patients. AHSNs open doors to create a more conducive environment for industries to work more effectively with the NHS and other parts of the UK healthcare sector. The diversity of AHSN priorities and programmes reflects the diversity of the challenges of improving health and wealth in each region. However every AHSN shares a focus on: Promoting economic growth Diffusing innovation Improving patient safety Optimising medicine use Improving quality and reducing variation Putting research into practice All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 27 Study Management - Essential documents for the Conduct of a Clinical Trial Trial Master File (TMF) A Trial Master File (TMF) should be established before the start of a study. The TMF is a filing system, rather than a single file, that includes essential documents as defined by ICH-GCP that demonstrate the entire conduct of the study from beginning to end. Before the Clinical Phase of the Trial Commences documents should be generated and should be on file before the trial formally starts. Further information can be found at: http://ichgcp.net/8-essential-documents-for-the-conduct-of-a-clinical-trial Case Report Form (CRF) completion A CRF is a record of all the data and other information on each subject required by the research protocol. The ICH-GCP guidelines include strict guidance relating to CRF completion, as they are the official documentation of the trial for the authorities. The CRFs, along with source documentation are closely examined in the event of audit and inspection. The CRF should collect necessary information about: The enrolled subject. Administration of the study drug or intervention. Study specific procedures. The outcome of any assessments. Details of any safety reporting e.g. SAE’s (Serious Adverse Events) Only those personnel identified by the Principal Investigator should complete CRFs. These can include: Co-Investigators Clinical trial practitioners Research nurses/AHP Clinical Research Assistants Anyone completing a CRF should have completed the signature delegation log in the Investigator file, and provided a signed and dated copy of their CV. CRFs should be completed as soon as possible after the associated visit/patient assessment to ensure that the information is up to date and accurate. Before any monitoring or audit visits, it is essential to ensure that CRFs are as up to date as possible. There are guidelines to CRF completion with each study protocol. Some general points are given here for reference. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 28 Paper CRF Use a black ball point pen to complete paper CRFs If the CRF is on carbonless duplication paper, ensure that an appropriate separator is inserted Never leave blank spaces. If a section cannot be completed write, as appropriate, not known, not certain, test not done All entries must be legible Cross out incorrect entry with a single line, so that the original entry is still legible Enter the correct data Initial and data correction If it is not obvious, then give an explanation for alterations The CRF for each patient MUST be signed off by the principle Investigator to indicate that they believe that they are complete and correct Electronic CRF Adequate online training with the system to be used is required and will be facilitated by the study sponsor A password will be issued to each individual authorised to access the system to enter data and should be kept safe and never shared with others Data should be entered as soon as possible after the subjects scheduled visit Corrections and query resolution is auditable through the electronic system Provision is required at site to facilitate monitoring visits and access to the electronic system Computers should not be left unattended with patient data on screen even though anonymised. Adherence to the relevant data protection legislation is mandatory Accurate and thorough completion of the CRF is essential as it is the only source of data that will be received by the sponsor company. Source documentation Many items of data generated during routine and study related care episodes constitute source documentation. For example, blood results, radiology reports, pharmacy prescriptions, letters in medical notes, hand written notes in the patients record all constitute primary source data. The development of study related source data sheets to capture relevant data items at designated study visit time-points are helpful in ensuring that items are not overlooked or missed in error and can significantly improve data quality overall. Such source sheets then also become primary source data and should be retained with the subject’s medical notes for monitoring and data verification. If source data sheets are created they need to be version controlled and signed and dated on completion of primary data entry. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 29 Induction Resource for Clinical Research Delivery Staff Appendices - Printable Resources All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 30 Appendix I - Induction checklist Form to be completed by you and your manager. Training/activity Required Yes No Date of training Employee Signature Managers Signature Good Clinical Practice (GCP) training Human Tissue Act training Read Trust Research Governance Policy Handling and packaging samples for transport (COSHH) Medical devices training EDGE training Informed Consent training Attend a Clinical Research Forum meeting Establish a research buddy Induction registration form completed and returned Stock ordering training Completed and returned induction resource feedback form Electronic database training e.g. PPM/PAS This list is not exhaustive and there may be other training relevant to your area. PRINTABLE PAGE FOR TRAINING FILE All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 31 Appendix II - Induction Resource Registration Form Name Job title and band Area of work/speciality Managers name and contact details Contact phone number Work email address Start date Please complete, and return this form during the first week of your employment in your new post. You will receive notification of receipt as evidence of completion for your induction. Please return to Research and Innovation via email to [email protected] http://www.leedsth.nhs.uk/research Good luck in your new role! All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 32 Appendix III- Research CV Template SUBMISSION OF CURRICULUM VITAE (CV) TO RESEARCH ETHICS COMMITTEES AND NHS R&I OFFICES Guidance for applicants Your CV needs to demonstrate that you are qualified by education, training and experience to conduct the research. A standard template for an Investigator CV is set out below. This template would be suitable for submission of CVs by: • Chief Investigators (for submission with main REC application) • Local Principal Investigators (for submission with the Site-Specific Information Form to RECs and NHS R&I offices) • Academic supervisors (for submission with student applications). The template is issued as guidance and is not intended to be prescriptive. Use of the template is not a requirement for a valid application. The National Research Ethics Service (NRES) Standard Operating Procedures state that CVs should be a maximum of 2 pages. This is also guidance and is not an absolute requirement. It is important that experience relevant to the specific research project is fully summarised, but the overall document should be kept concise. It is not necessary to provide a complete record of the applicant’s professional and academic background. In particular, CVs should not include lengthy lists of publications. This template is recommended by NRES and the NHS R&I Forum for applications both for ethical review and R&I approval All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 33 Research CV Name: Present appointment: (Job title, department, organisation) Address: (Full work address) Telephone number: Email address: Qualifications: Professional registration: (Name of body, registration number and date of registration) Previous and other appointments: (include previous appointments in the last 5 years and other current appointments) Research experience: (Summary of research experience, including the extent of your involvement. Refer to any specific clinical or research experience relevant to the current application) Research training: (Details of any relevant training or conduct of research, for example in the Clinical Trials Regulations, Good Clinical Practice, consent or other training appropriate to non-clinical research. Give the date of the training) Relevant publications: (Give reference to all publications in the last two years plus other publications relevant to the current application) Signature: Date: All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 34 Appendix IV - Example Training File NIHR Leeds CRF Training File NIHR Leeds Clinical Research Facility Training File Name: Job Title: Start Date: Leave Date Confidential: UNAUTHORISED COPYING PROHIBITED Page 35 of 50 Quality Assurance Department, NIHR Leeds Clinical Research Facility, St James Institute of Oncology, Level 6 Bexley Wing, Beckett Street, Leeds, LS9 7TF, UK All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 35 1 2 3 4 Copy of job description Signed and dated CV (Documented on the NRES CV template. Renewed annually, retain all versions) Membership of professional associations (e.g. NMC, National or local cancer groups, RCN – include copy of official notification of membership/renewal) Records of all research specific training (Including GCP certificates) -If not certificated, retain schedule/agenda/hand-outs 5 Records of all mandatory Trust specific training. (e.g. health and safety training) -If not certificated, retain schedule/agenda/hand-outs 6 Records of all other continuing education – courses/seminars/training sessions. (Include induction programme) 7 Copies of Publications/Presentations 8 Copies of professional and higher educational certificates 9 Departmental SOP log 10 Miscellaneous Confidential: UNAUTHORISED COPYING PROHIBITED Page 2 of 50 All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 36 Appendix V - Research acronyms Acronym ABPI ACFs ADE AE AHC AHPs AHSN AMRC AMS ARSAC BBSRC BIA BRCs BRUs CATP CCF CCG CDA CI CLAHRC CPMS CQC CRA CRA CRD CRF CRFs CRN CRN CRO CRUK CSP CSR CSU CT Toolkit Definition Association of British Pharmaceutical Industry Academic Clinical Fellowship Adverse Device Effect Adverse Event Applied Health Co-operative Allied Health Professionals Academic Health Science Network Association of Medical Research Charities Academy of Medical Sciences Administration of Radioactive Substance Advisory Committee Biotechnology & Biological Sciences Research Council Bio Industry Association Biomedical Research Centres Biomedical Research Units Clinical Academic Training Programme Central Commissioning Facility Clinical Commissioning Groups (e.g. GPs) Confidentiality Agreement Chief Investigator Collaborations for Leadership in Health Research Care Central Portfolio Management System Care Quality Commission Collaborative Research Agreement Clinical Research Associate (Monitor) Centre of Reviews and Dissemination Case Report Form Clinical Research Facilities for Experimental Medicine Clinical Research Nurse Clinical Research Network Clinical Research Organisation Cancer Research UK Coordinated System for gaining NHS Permission Comprehensive Spending Review Clinical Support Unit Clinical Trials Toolkit All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 37 CTA CTA CTC CTFs CTIMP CTRUs CV D4D DARE DECs Dementia TRC DH DMC DRFs DSMB ECMCs EME EMEA EOI EORTC EPSRC ESRC EudraCT FDA FP FT GCP GLP GMP HCAP HEE HEI HICF HLO HRA HRA HS&DR HSC Clinical Trials Authorisation Clinical Trials Assistant Common Toxicity Criteria Clinical Trials Fellowship Clinical Trials involving Medicinal Products Clinical Trials Research Units Curriculum Vitae Devices for Dignity Database of Abstracts of Reviews of Effects Diagnostic Evidence Cooperative Dementia Translational Research Collaboration Department of Health Data Monitoring Committee Doctoral Research Fellowship Data Safety and Monitoring Board Experimental Cancer Medicine Centres Efficacy and Mechanism Evaluation Programme European Medicines Evaluation Agency Expression Of Interest European Organisation for Research and Treatment of Cancer Engineering & Physical Sciences Research Council Economic & Social Research Council European Drug Regulation Authorities in Clinical Trials Food and Drug Administration (US) Fellowships Programme Foundation Trust Good Clinical Practice Good Laboratory Practice Good Manufacturing Practice Honorary Clinical Associate Professor Health Education England Higher Education Institute Health Innovation Challenge Fund High Level Objectives (Clinical Research Network) Health Research Authority Health Research Authority Health Services and Delivery Research Programme Horizon Scanning Centre All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 38 HSP HSR HSRN HTA HTCs HTMR i4i IAT IB ICF ICH GCP ICR IMP INVOLVE IP IRAS IRMER IS ISR KMFs KPI KSF LMBRU LS&DP LTHT mCIA mCTA MEDTECH MHRA MoU MRC MRC-NIHR NPC MRP NDA NETS CC NGO Healthcare Scientists Programme Health Service Research Health Services Research Network Health Technology Assessment Programme Healthcare Technology Co-operatives Hubs for Trials Methodology Research Innovation for Innovation Programme Integrated Academic Training Programme Investigator Brochure Informed Consent Form International Conference on Harmonisation - Good Clinical Practice Institute of Clinical Research Investigational Medicinal Product INVOLVE Patient Involvement national advisory group Intellectual Property Integrated Research Application System Ionising Radiation Medical Exposure Regulations Information Systems Programme Independent Scientific Review Knowledge Mobilisation Fellowship Key Performance Indicator Knowledge and Skills Framework Leeds Musculoskeletal Biomedical Research Unit Leadership Support & Development Programme Leeds Teaching Hospitals NHS Trust model Clinical Investigation Agreement model Clinical Trial Agreement Medical Technology Companies Medicines and Healthcare Products Regulatory Agency Memorandum of Understanding Medical Research Council MRC-NIHR National Phenome Centre Methodology Research Programme Non-Disclosure Agreement NIHR Evaluation, Trials and Studies Coordinating Centre Non-Governmental Organisation All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 39 NHS NHS E NHS EED NICE NIHR NIHR BRC NIHR BRU NIHR CCF NIHR DEC NIHR HTA NIHR PGfAR NIHR RDS NIHR RfPB NIHR TCC NOCRI NRES ODP OGD OSCHR PAS PCPIE PDAs PDGs PHARMA PHE PHR PI PID PIS PIS PPI PPM PRA PROSPERO PRP PSTRC QA R&D National Health Service NHS England NHS Economic Evaluation Database National Institute for Health & Care Excellence National Institute for Health Research NIHR Biomedical Research Centres NIHR Research Biomedical Research Units NIHR Central Commissioning Facility NIHR Diagnostic Evidence Co-operative NIHR Health Technology Assessment NIHR Programme Grants for Applied Research NIHR Research Design Service NIHR Research for Patient Benefit NIHR Trainees Coordinating NIHR Office for Clinical Research Infrastructure National Research Ethics Service Open Data Platform Other Government Department Office for Strategic Co-ordination of Health Research Patient Administration System Patient, Carer & Public Involvement & Engagement Product Development Awards Programme Development Grants Pharmaceutical companies Public Health England Public Health Research Programme Principal Investigator Performance in Initiation & Delivery Patient Information Sheet Patient Information Sheet Patient and Public Involvement Patient Pathway Management (system) Patient Research Ambassadors Database of Prospectively Registered Systematic Reviews Policy Research Programme (DH) Patient Safety Translational Research Centre Quality Assurance Research and Development All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 40 R&I RCD RCF RCGP RCN RCT RDS REC REF RET RFPB RM&G RMP RP RSS RTT SAE SAR SLA SME SOP SSA STRF SUSAR TARs TCC TMF TRFs TRPs TSF UK CRGs UK CTG UKCC UKCRC UKTI UoL YH Research & Innovation Research Capacity Development Research Capability Funding Royal College of General Practitioners Royal College of Nursing Randomised Controlled Trials Research Design Service Research Ethics Committee Research Excellence Framework Research, Education and Training Committee Research For Patient Benefit Programme Research Management and Governance Research Methods Programme Research Passport Research Support Service Recruitment to Time & Target Serious Adverse Event Serious Adverse Reaction Service Level Agreement Small, Medium Enterprise Standard Operating Procedure Site Specific Assessment Science & Technologies Facilities Research Council Suspected Unexpected Serious Adverse Reactions Technology Assessment Reviews Trainees Coordinating Centre Trial Master File Transitional Research Fellowships Translational Research Partnership Trial Site File UK Cochrane Review Groups UK Clinical Trials Gateway UK Cochrane Centre UK Clinical Research Collaboration UK Trade and Investment University of Leeds Yorkshire and Humber All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 41 Appendix VI - Glossary Adverse Reactions Arm Baseline Bias Blind, Blinded, or Blinding Case Control Study Chief Investigator Clinical Research Associate (CRA) Clinical Research Coordinator (CRC) Clinical Research Organisation (CRO) Clinical Trial Clinical Trial Authorisation Clinical Trial of an Investigational Medicinal Product (CTIMP) Also known as side effects, adverse reactions include any undesired actions or effects of the experimental drug or treatment. Experimental treatments must be evaluated for both immediate and long-term side effects. Any of the treatment groups in a clinical trial. Most randomised trials have two “arms”, or even more. Baseline information is gathered at the beginning of a study from which variations found in the study are measured. Baseline can also be described as a known value or quantity with which an unknown is compared when measured or assessed. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values. When a point of view prevents impartial judgement on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomisation. A clinical trial is “blinded” if the participants are unaware on whether they are in the experimental or control arm of the study. Blinding may also be extended to the investigators so that their patient observations are less likely to be biased by their awareness of the treatment the patient is receiving. A scientific study that compares a group of people with a disease to a similar group of people without that disease. Researcher in charge of carrying out a clinical trial protocol Person employed by the study sponsor or clinical research coordinator to monitor a clinical trial at one or more participating sites. The CRA is responsible for ensuring all clinical studies are conducted according to study protocol, within regulations and ICH guidelines. Site Administrator for the clinical trial who is responsible for coordinating administrative activities between field and home offices staff, such as the collection of essential documents, distribution of supplies and site selection. Also called research study or health care coordinator, data manager, research nurse or protocol nurse. A commercial organisation contracted by a research and development organisation to perform one or more research related functions. A clinical trial is a research study designed to methodologically answer specific questions about novel therapies, treatment techniques or new ways of using known treatment. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. The authorisation from the MHRA as Competent Authority, in the UK to conduct a clinical trial of an investigational medicinal product (CTIMP). Is any investigation in human subjects, other than non-investigational trial, intended to a) discover or verify the clinical, pharmacological or other pharmacodynamics effects of one or more medicinal products; b) to identify any adverse reactions to one or more such products or c) to study absorption, distribution, metabolism and excretion of one or more such products with the object of ascertaining the safety or efficacy of those products. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 42 Clinical Trial Regulations Cohort Community-based Clinical Trial Complementary and Alternative Therapy Confidentiality Regarding Trial Participants Contraindication Control Group Controlled Trials Crossover Trials Data Safety and Monitoring Board (DSMB) Demographic Data Device Diagnostic Trials Dose-ranging Study The Medicines for Human Use (Clinical Trials) Regulations 2004 In epidemiology, a group of individuals with some characteristics in common. A method of providing experimental therapeutics prior to final approval for use in humans, this procedure is used with very sick individuals who have no other treatment options. Often approval is on a case-by-case basis. Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or treat health conditions. Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants consent to the use of their records for data verification purposes should be obtained prior to the trial and assurance must be given that confidentiality will be maintained. A specific circumstance when the use of certain treatments could be harmful. The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo (See Placebo and Standard Treatment). A control is a standard against which experimental observations may be evaluated. In a controlled clinical trial, one group of participants is given an experimental drug, while another group (i.e. the control group) is given either a standard treatment for the disease or a placebo. A clinical trial in which all participants receive both treatments, but at different times. At a predetermined point in the study, one group is switched from the experimental treatment to the control treatment (standard treatment), and the other group is switched from the control to the experimental treatment. An independent committee composed of community representatives and clinical research experts that review data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved. The characteristics of participant group or populations. This could include data on race, age, sex and medical history, all of which can be relevant to the clinical trial study findings. An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory that is used to diagnose, cure, treat or prevent disease. A device does not achieve its intended purpose through chemical action or metabolism in the body. Refers to trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or illness being studied. A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 43 Double-Blind Study Drug-Drug Interaction Efficacy Eligibility Criteria Empirical Endpoint Epidemiology Ethics Committee (or Institutional Review Board) EU Directive Expanded Access Food and Drug Administration (FDA) Health Research Authority (HRA) Hypothesis Inclusion/Exclusion Criteria A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving the placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participants about the experimental drug do not affect the outcome (See Blind, Single-Blind Study and Placebo). A modification of the effect of a drug when administered with another drug, the effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug. The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. Summary criteria for participant selected; includes inclusion and exclusion criteria (See Inclusion and Exclusion Criteria). Based on observation or experience, not experimental data. Overall outcome that the protocol is designed to evaluate. The branch or medical science that deals with the study of incidence, distribution and control of a disease in a population. A committee of doctors, statisticians, researchers, community advocates and others that ensure that the rights of study participants are protected. Every institution that conducts or supports biomedical or behavioural research involving human participants must, by federal regulation have an ethics committee (IRB) that approves and periodically reviews the research in order to protect the rights of human participants. Directive 2001/20 EC of the European Parliament and the Council of the European Union relating to the implementation of good clinical practice in the conduct of the clinical trials of medicinal products for human use. Refers to the distribution of experimental drugs to participants who are failing on currently available treatments for their condition and who are also unable to participate in on-going clinical trials. The US Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines and medical devices, including those used in the diagnosis, treatment and prevention of HIV infection, AIDS and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the US national blood supply. The HRA works closely with the MHRA and NIHR creating a unified approval process and to promote proportionate standards for compliance and inspection within a consistent national system of research governance A supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation. The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial, these criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants and keep them safe. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 44 Informed Consent Informed Consent Document Intent to Treat Interventions Investigational Medicinal Product (IMP) Investigator’s Brochure (IB) IN VITRO IN VIVO Lead Site Medicines and Healthcare products Regulatory Agency (MHRA) Meta-Analysis Multi-Centre Trial National Research Ethics Centre The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the whole of the study to provide information to participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the whole of the study to provide information to participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Analysis of clinical trial results that include all data from participants in the groups to which they were randomised even if they never received the treatment. Primary experimental treatments being studied. Types of treatments may include drug, gene transfer, vaccine, behaviour, device or procedure. A pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial and includes a medicinal product which has a marketing authorisation but is, for the purposes of the trial: a) Used to be assembled (formulated or packaged) in a different way from the form of the product authorised under the authorisation; b) Used for an indication not included in the summary of product characteristics under the authorisation for that product; c) Used to gain further information about the form of that product as authorised under the authorisation A document containing a summary of the clinical and non-clinical data relating to an investigational medicinal product which are relevant to the study of the product in human subjects. Testing or action outside an organism (e.g. inside a test tube or culture dish). Testing or action inside an organism, such as a human subject or patient. In the case of a multi-site study, the site for which the Chief Investigator is also the Principal Investigator. Is the competent authority for the UK in relation to the EU Directive and the Clinical Trials Regulations. MHRA (Devices) is the competent authority for the UK in relation to the Medical Devices Regulations 2002. Systematic methods that use statistical techniques for combining results from similar studies to obtain a quantitative estimate of the overall effect of a particular intervention or variable on a defined outcome. This type of analysis is typically hypothesis generating. Clinical trial conducted according to a single protocol but at more than one site and therefore carried out by more than one investigator. Directorate within the National Patient Safety Agency that provides help and leadership for RECs by co-ordinating the development of operational and infrastructure arrangements in support of their work. This includes implementing standards to ensure national consistency, providing training for REC members and Co-ordinators, identifying IT solutions for procedural management and establishing regional REC centres to manage RECs. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 45 Observational Study Off-Label Use Open Label Trial Outcome Trial/Study P-Value Parallel Study Peer Review Pharmacology Pharmacokinetics Pharmacovigilance Pivotal Study Placebo Placebo Controlled Study Placebo Effect An epidemiological study that does not involve any intervention, experimental or otherwise. Such a study may be one in which nature is allowed to take its course, with changes in one characteristic being studied in relation to changes in other characteristics. Analytical epidemiologic methods such as case-control and cohort study designs are properly called observational epidemiology because the investigator is observing without intervention other than to record, classify, count and statistically analyse results. A drug prescribed for conditions other than those approved by a country’s regulatory agency. A clinical trial in which doctors and participants know which drug or treatment is being administrated. An outcomes trial evaluates the effects of a treatment on patients. Treatments may include changes in disease status, morbidity or mortality. A p-value demonstrates the likelihood that sample data do not adequately represent the population from which they were drawn. The accepted standard for a statistically significant p-value is <0.05 meaning that the likelihood that the result could occur by random chance is less than 5 in a hundred. A parallel designed clinical trial compares the results of a treatment on two separate groups of patients. The sample size calculated for a parallel design can be used for any study where two groups are being compared. Review of a clinical trial by experts chosen by the study sponsors. These experts review the trial for scientific merit, participant safety and ethical considerations. The study of how drugs interact with living organisms to produce a change in function. Pharmacology deals with how drugs interact within biological systems to affect function. The process of absorption, distribution, metabolism and excretion of a drug or vaccine. The science of collecting, monitoring ,researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identify new information about hazards associated with medicines and preventing harm to patients. A study, usually phase three, which represents the data used by regulatory agencies to decide whether to approve a drug. A pivotal study will generally be well-controlled, randomised and whenever possible double- blind. A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatments effectiveness. A method of investigation of drugs in which an active substance is given to one group of patients, while the drug that is being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition. A physical or emotional change occurring after an inactive substance is taken or administered that is not the result of any special property of the substance. The change may be beneficial reflecting the expectations of the participant and often the expectations of the person giving the substance. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 46 Preclinical Trials Prevention Trials Principal Investigator (PI) Prospective Study Protocol Quality of Life Trials Randomisation Randomised Trial Retrospective Study Risk –Benefit Ratio Screening Trials Serious Adverse Event (SAE) Serious Adverse Reaction (SAR) Side Effects Single Blind Site Specific Assessment (SSA) Sponsor Standard Treatment Experiments performed in the laboratory and in animals to study a drug before it is tested in humans. Conducted to find better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes. The investigator responsible for the research site where the study involves specified procedures requiring site-specific assessment. There should be one PI for each research site. In the case of a single-site study, the CI and the PI will normally be the same person. A prospective study identifies subjects, applies a treatment and follows them over time to measure their progress/outcomes relative to a predetermined set of criteria or endpoints. A document that describes the objectives, design, methodology, statistical considerations (or other methods of data analysis) and organisation of a research study. Refers to trials that explore ways to improve comfort and quality of life for individual’s chronic illness. A method by which study participants are assigned to a treatment group. Randomisation minimises the differences among groups by equally distributing people among the trial arms. A study in which participants are randomly assigned to one of two or more treatment arms of a clinical trial. A study in which investigators select groups of patients that have already been treated and analyse data from the events experienced by these patients. These studies are subject to bias because investigators can select patient groups with known outcomes. The risk a treatment places on individual participants versus the potential benefits of the treatment. Refers to trials which test the best way to detect certain diseases or health conditions. Serious adverse event, an untoward occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity or consists of a congenital anomaly or birth defect. A serious adverse reaction in a CTIMP that results in death; is lifethreatening; requires hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability or incapacity; or consists of a congenital anomaly or birth defect. Any undesired actions or effects of a drug or treatment. Experimental drugs must be evaluated for both immediate and long term side effects A study in which one party, either the investigator or participant is unaware of what medication the participant is taking. An assessment of the suitability of the investigator, site and facilities made for any study with a Principal Investigator at each research site. The person who takes on ultimate responsibility for the initiation, management and financing (or arranging the financing) of a clinical trial. A treatment currently approved, in wide use and considered to be effective in the treatment of a specific disease or condition. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 47 Statistical Significance Study Endpoint Surrogate Endpoint Suspected Unexpected Serious Adverse Reaction (SUSAR) Toxicity The probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made as well as the magnitude of the differences observed. An outcome used to judge the safety or effectiveness of a treatment. A biomarker or endpoint that is intended to substitute for a clinical endpoint. A surrogate endpoint is expected to predict a clinical endpoint or lack thereof. A SUSAR is a CTIMP which is unexpected, meaning that its nature and severity are not consistent with the information about the medicinal product in question set out: a) In the case of a product with a marketing authorisation, in the summary of productcharacteristics for that product; b) In the case of any other investigational medicinal product, in the investigator’s brochure relating to the trial in question. A treatment related adverse effect that may be detrimental to the recipient’s health. The level of toxicity associated with a treatment will vary depending on the attributes of the treatment itself and the condition the drug is being used to treat. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 48 Appendix VII - Evaluation Form Evaluation Form Clinical Research Induction Resource 1. How long have you worked in Clinical Research? Please tick 1 - 6 Months 6 - 12 Months 1 - 2 years 2 - 4 years 5 - 9 years 10 years + 2. What band are you? Please tick Band 2 Band 3 Band 4 Band 6 Band 7 Band 8 Band 5 3. Have you used a formal clinical research induction resource before? Yes: No If YES please list:___________________________________ 4. What is your overall assessment of the usefulness of the clinical research induction resource? (1 = insufficient - 5 = excellent) please circle below 1 2 3 4 5 5. Which topics/sections of the clinical research induction resource did you find most interesting or useful? All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 49 6. Has the clinical research induction resource helped you and your manager to successfully complete your induction to your new role? Yes No If no, why? 7. Knowledge and information gained from using the clinical research induction resource? Met your expectations: Yes No Somewhat Will be useful /applicable in my work: Definitely Mostly Somewhat Not at all 8. Do you have any comments or suggestions that would improve this research induction resource? THANK YOU! Please email this evaluation to: [email protected] or [email protected] or [email protected] This is an iterative document and links or advice may change. Please consult the R&I website or team for advice as appropriate in the first instance. All printed copies of this Document are considered 'Uncontrolled Copies'. Printed copies are only valid for the day printed Induction resource Version 1.0. FINAL. 13.12.2016 50
