The Clinical Research Team: Roles and Responsibilities

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/0-10000000/0-10000/3367/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/ucm164171.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)