Download 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/0-10000000/010000/3367/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):
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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
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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
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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
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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
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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
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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
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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:
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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
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Maintains adequate supply of study medication
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Maintains drug accountability
Acts as consultant to research staff regarding drug interactions and study medications
Study Participant:
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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)