201 Essential Document Management and Retention

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 process for creating and maintaining study regulatory files, subject records, and record retention which are periodically reviewed by the sponsor and may be requested by the FDA or other regulatory authorities. Attachment templates include:

A: Essential Document Checklist, B: Regulatory Documents Checklist, C: Study Termination Checklist

• The PI or delegated research team members will create and maintain study regulatory files for each clinical research study that will contain required, original, and revised essential documents (See Attachment A: Essential Document Checklist and Attachment B: Regulatory Documents Checklist).
• All study-related essential regulatory and subject documents will be kept confidential and stored in a secure and limited access location, meeting institutional privacy and security policy expectations. Upon request of the monitor, auditor, IRB, sponsor or regulatory authority, the PI and delegated research team members will make all essential documents available for review.
• The investigational site will receive written and dated approval from the IRB and other regulatory bodies, if required, for the protocol, Informed Consent Form, HIPAA authorization, subject recruitment procedures (e.g., advertisements), and any other information to be provided to subjects prior to implementing any study activities. 

• The PI or delegated research team members will create and maintain study specific subject files for each consented subject. These files will contain required original essential documents such as source documents used for case report form data elements, original signed Informed Consent Forms (ICF) and HIPAA authorization forms, protocol deviations, adverse events (AE), Case Report Forms (CRF) and Serious Adverse Event (SAE) reports (See Attachment A: Essential Document Checklist).
• The PI or delegated research team members will ensure that the study regulatory files are organized, complete and accurate. Any additional documentation created or received over the course of the study will be filed appropriately. All original documents will be maintained and revised documents will be added to the study regulatory file (See Attachment B: Regulatory Documents Checklist). 

• To prepare for a study termination/close-out visit with the sponsor, the PI or delegated research team member will:
  • Complete all CRFs and source documents at study visits and before the final closeout monitoring visit.
  • Complete all requests for data corrections or verifications on CRFs and return them to the Sponsor.
  • All Investigational Product (IP), when applicable, is collected from all subjects and inventoried, including used and unused IP.
  • The used and unused IP supplies are returned to the Sponsor as specified. Copies of the IP logs, final inventory, and return documents are filed in the regulatory binder.
  • All other Sponsor-required reports are completed, with a copy filed in the regulatory binder and another copy sent to the Sponsor and/or Institutional Review Board (IRB) as applicable.
  • Evaluate requirements for data storage and prepare for a potential sponsor quality assurance review or FDA inspection (See Attachment C: Study Termination Checklist).
  • The delegated personnel stores CRFs, source documents, and the regulatory binder, and informs the Sponsor of the storage location. Records are stored according to the records retention policy.
• The PI or delegated research team member will notify the IRB and any other appropriate entities when the study has been closed.