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THE CLINICAL RESEARCH TEAM: ROLES AND RESPONSIBILITIES Clinical research is a cooperative effort by a team of professionals and other staff. The goals of the team include the protection of patients who have voluntarily agreed to participate in the trial, and a commitment to the integrity of the data generated in the trial. These goals are achieved by a relatively small group of people, facing common and sometimes unique challenges in large, complex institutions. It is wonder that clinical research can be accomplished in such settings! Summary/overview of roles and responsibilities http://clinicaltrial.vc.ons.org/file_depot/0-10000000/010000/3367/folder/14779/Roles_of_the_Research_Team1.pdf http://jop.ascopubs.org/content/7/3/188.full.pdf Study research teams may have many members or responsibilities may be distributed among a small number of members. Although teams vary in composition, some of the common responsibilities are listed below: Principal Investigator (PI): Ultimate responsibility and oversight of trial in a particular organization. In some cases, the same person may be the overall lead for the clinical trial across all institutions Delegation of tasks to appropriately trained staff. Ensure staff education Implement ethical research consistent with the Belmont Report http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html Comply with Federal Regulations http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.html Ensure that all research protocols are submitted to the institution’s IRB for approval and comply with the IRB mandates http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm164 171.htm Ensure that research is carried out in according to the protocol with IRB changes Ensure informed consent of all research participants by appropriate staff and documentation of the consenting process http://www.fda.gov/regulatoryinformation/guidances/ucm126431.htm Report on the progress of the research to the IRB, including continuing reviews, unanticipated events, and serious adverse events. Report adverse events to sponsor and FDA as appropriate http://www.hhs.gov/ohrp/policy/advevntguid.html http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126572.pdf Familiarity with contents of the Investigator Brochure (risks of investigational agent to study participants) Maintains Form 1572 (agreement to provide information to the sponsor and to comply with FDA regulations) http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf Ensures records are maintained for at least 3 years past the completion of all research activities. The responsibilities of the clinical investigator: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3051859/pdf/jop124.pdf Sub-Investigator: Other investigators on the Form 1572 and under the direction of the PI Familiarity with the research protocol Implement and comply with the protocol as written with IRB changes Participate in Informed Consent process and documentation Participate in timely reporting of adverse events and unanticipated events to the IRB and sponsor Clinical Trial Nurse (CTN): Coordinates the clinical trial and patient care Maintain patient safety and trial integrity Participate in the advancement of science in oncology (evidence-based practice) Provide education to participants and caregivers, and colleagues Help research participants navigate the protocol and the system Ensure ongoing participant informed consent Facilitate communication and coordination across systems Identify strategies for accomplishing requirements of the protocol Collaborate with Investigators to evaluate patients for potential clinical trial participation and eligibility Identify trends in side effects and participant management strategies. In collaboration with the PI, ensure reporting of unanticipated/adverse events. The Domain of Clinical Research Nursing: Clinical research nurse taxonomy developed at the NIH and based on a role delineation study. The domain of clinical research nursing is divided into the following dimensions, each dimension defined by certain activities: clinical practice, study management, care coordination and continuity, human subject protection, and contributing to science. http://www.cc.nih.gov/nursing/crn/DOP_document.pdf http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3304543/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3304545/ The Oncology Nursing Society Oncology Clinical Trials Nurse Competencies (2010) http://www.ons.org/media/ons/docs/publications/ctncompetencies.pdf Study Manager: Supervises the research program Oversees quality assurance activities Supervises research staff (regulatory coordinator, study coordinator and data manager), and advocates for additional staff Supervises research staff training and evaluation Supervises budgeting activities Supervises audit of affiliate sites In collaboration with the PI, ensures that all investigator responsibilities are met Regulatory Coordinator: Maintains regulatory activities Submits new protocols to the IRB Supervises and/or completes required IRB and sponsor reports Maintains communication among the study staff, the sponsor and the IRB Submits safety data Maintains files relating to communication with the IRB and sponsor Maintains Form 1572, current Investigator licenses and CVs Study Coordinator: Assists in the implementation of clinical trial In collaboration with CTN, maintains participant calendars and schedules Assists Regulatory Coordinator as needed In collaboration with CTN, ensures that all protocol requirements are accomplished as outlined the written document (tests, scans, blood samples, questionnaires, etc) Data Manager: Organizes records and source documents Tracks completion of the case report forms (CRF) Maintains and validates data entry in the CRF system Manages discrepancies in data entered in CRF system Staff Nurse: Ensures knowledge of and access to the research protocol Is aware of resources for questions and concerns Administers investigational drugs Monitors participants for adverse effects to the study agent Research Pharmacist: Maintains drug supply Maintains adequate supply of study medication Maintains drug accountability Acts as consultant to research staff regarding drug interactions and study medications Study Participant: Expresses agreement to participate in the requirements of the study Expresses agreement to participate in the accurate administration of the study medication Agrees to communicate with the study team regarding adverse events (which may or may not be related to the study medication)