SOP for Responsibilities of the Research Team

PURPOSE

This SOP describes how responsibility and accountability for clinical trials is allocated among members of the research team. In clinical trials which are investigator initiated, the Principal Investigator also assumes the responsibilities of the Sponsor. It describes administrative accountability as well as general responsibilities of the research team and of individual team members for fulfilling regulatory and clinical requirements.

RESPONSIBILITIES OF THE RESEARCH TEAM

Principal Investigator/Co Principal Investigator: Each clinical trial will have a Principal Investigator (PI) (and may have a Co PI) who is the individual of record who assumes authority and accountability for the ethical conduct of a clinical study in accordance with all applicable federal and state laws and regulations and with institutional policy. The PI and Co PI are each fully responsible for:

1. The safety and welfare of participants in the trial.
2. Reading and understanding all the information in the grant documents, the investigator’s brochure, the informed consent, and the protocol
3. Informing all participants, including participants used as controls, that the investigational agents are being used for investigational purposes and following all requirements relating to obtaining informed consent.
4. Preparing and submitting protocol documents for initial IRB review and approval.
5. Conducting study activities only after IRB approval and in accordance with the approved protocol, and assuring that Institutional Review Board requirements are met.
6. Reporting adverse events to the Sponsor as they require.
7. Implementing modifications in approved research only after review and approval of the modification by the IRB, except where necessary to eliminate apparent immediate hazards to participants.
8. Appropriate control, inventory, distribution, storage, record keeping and destruction or return of test articles.
9. Prompt reporting to the IRB of all events that require prompt reporting (See Policy II.02 and SOP # 3-2, Promptly Reportable Events).
10. Providing progress reports to the IRB in a timely manner.
11. Assuring that federal (FDA and HHS), state, and local laws and regulations governing clinical trials and that the policies and procedures of the University of Cincinnati are followed.
12. Assuring the disclosure of financial interest and arrangements to the sponsor and the IRB, and if required by the IRB, to participants, by any member of the research team that may present a conflict with the interests of participants in the study.
13. While retaining knowledge of and overall authority for the conduct of all research studies, supervise members of the research team qualified by appropriate education and experience to accept responsibility for study-related activities not directly performed by the PI. Assuring that delegation of responsibilities is appropriate and is documented and that individuals recruited as members of the research team are appropriately licensed and trained.
14. Maintaining adequate and accurate records and making records available for inspection to external and internal monitors. Meeting with auditors (FDA, sponsor and internal), at the conclusion of their audits, to review findings and to implement changes to correct weaknesses or deficiencies.
15. The PI/Co PI may delegate responsibility to individual members of the research team; however, the PI/Co PI cannot delegate accountability for the ethical conduct of the study. The PI must sign the form that delegates responsibilities to each member of the research team. Each individual’s name must be initialed and dated. The form must be updated, initialed and dated, each time there is a personnel change

Sub-Investigator: Any individual member of the clinical trial team, qualified by education, experience, and with appropriate licensure or certification, designated by the Principal Investigator at a trial site to perform critical trial-related procedures or to make important trial-related decisions.

Clinical Research Coordinator/Clinical Research Nurse/Data Manager/Research Assistant/Research Lab Personnel (or PI for studies that do not have these functions)

The responsibilities may be delegated to the position with the level of training and experience appropriate to the task and in accordance with the requirements of the trial:

1. Screening and enrolling subjects in studies and managing their participation according to ethical, regulatory, and protocol-specific requirements.
2. Obtaining informed consent and a PHI Authorization (HIPAA) from trial subjects before performing any study related procedures.
3. Developing organizational aids and checklists to facilitate patient recruitment and the collection of complete and accurate study data.
4. Maintaining the regulatory and study files for each research project.
5. Communicating with the IRB as appropriate.
6. Assuring proper handling of the investigational product.
7. Reporting adverse events to the IRB and sponsor, as appropriate.
8. Meeting with sponsor representatives to discuss planned and ongoing studies.
9. Overseeing study closure and reporting of results.
10. Participating in quality assurance activities of the sponsor, the FDA, other regulatory and accrediting agencies and UC’s office of Compliance and Regulatory Affairs.
11. Supervising other clinical research personnel, as appropriate.
12. Participating as appropriate in the training of individuals recruited as members of the research team.
13. Managing the business aspects of studies, including developing and negotiating study budgets and, in conjunction with the Office of General Counsel East, facilitating the contract review process to assure that provisions on publication, intellectual property, indemnification, records retention, and data ownership are appropriately negotiated with the sponsor.
14. Design appropriate recruitment strategies and track study enrollment.
15. Accurate and timely data entry.
16. Proper handling of and accurately processing samples (such as blood and tissues).

ALL MEMBERS OF THE RESEARCH TEAM WILL:

1. Conduct clinical studies according to DHHS and FDA regulations and guidelines, Good Clinical Practices, Good Laboratory Practices, Institutional policies on research, HIPAA and departmental/division SOPs.
2. Assure the safety and welfare of study subjects by being knowledgeable about ongoing study protocols and investigational articles.
3. Comply with federal regulations governing disclosure of personal, professional or financial interests in a research study that may impact upon its conduct, evaluation or outcome.
4. Maintain confidentiality of all clinical trial related information (including patient records).
5. Fulfill job responsibilities specific to each job title according to federal regulations and guidelines as well as the appropriate job descriptions maintained at the site.
6. Assure that the PI is informed in a timely manner of all study-related activities.

REVISION HISTORY

Nil

ALSO READ: SOP for Pharmacovigilance