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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 1 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 2 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 3 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 4 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 5 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 6 of 21 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 6 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 21 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 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 8 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 9 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 10 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 11 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 12 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 13 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 14 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 15 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 16 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 17 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 18 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 19 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 20 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 21
