102 Delegation of Responsibilities

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.

This Standard Operating Procedure (SOP) describes the responsibilities of the PI and the procedures for identifying and delegating specific responsibilities to research team members for conducting clinical research. Attachment templates include:

A: Delegation of Authority (DOA) Log, B: Study Team Training Log

• Each clinical research study will have a designated research coordinator who performs and/or oversees the research as delegated by the PI.
• Conduct the clinical research study to ensure it is conducted according to the IRB-approved protocol, institutional policies, GCP, and applicable regulations.
• Design and maintain organizational tools to conduct the study accurately and comply with GCP.
• Ensure the safety and welfare of the study subjects.
• Train other site personnel in understanding and implementing the protocol.
• Recruit and screen the potential study subjects according to the protocol's inclusion and exclusion criteria.
• Obtain proper written informed consent from each study subject before participation in the study
• Assign study subject numbers, schedule study subjects' visits, and perform delegated activities of the study completely and accurately. 
• Report all adverse events to the PI.
• Maintain adequate and accurate case histories for each study subject that record all observations and data during the study.
• Complete the Case Report Forms (CRFs) for the study accurately and completely.
• Maintain accurate and complete records of the receipt, dispensing, and return of all clinical supplies and note all discrepancies.
• Maintain all required documentation in the study documentation file.
• Communicate with the Sponsor regarding study activities as necessary.
• Meet with the Sponsor's representatives to discuss the conduct of the study and review study data.

• The PI assumes the authority and responsibility for the conduct of a clinical research study. However, the PI has the authority to delegate responsibilities to individual research team members, if appropriate.
• The PI may select Sub-Investigators with appropriate education and training to ensure the investigation is conducted according to the signed investigator statement, the investigational plan, GCP, institutional policies, and applicable regulations.
• The PI may determine the appropriate delegation of authority to specific research team members for each clinical research study conducted at this investigational site.
• Delegation of specific responsibilities will be documented appropriately and kept on file with the regulatory documents for each clinical research study (See Attachment A: Delegation of Authority Log). Study team members who have significant trial-related duties as determined by the PI will be listed on the DOA log.
• All members of the research team who are delegated specific responsibilities should communicate regularly with the PI to ensure he/she is informed in a timely manner of all study-related activities.