Clinical Research Operations

Guidelines for Development and Maintenance of Regulatory Files/Binders

Purpose: To provide direction for the development and maintenance of regulatory files/binders.

STEP 1: Develop Regulatory Files/Binders for Each Study

1. For each study that is activated, a file folder or binder is created for essential regulatory documents collected during the study to ensure compliance with Federal regulatory guidelines and principles of GCP.
2. For all studies, all original documents and any subsequent versions should be maintained in this file/binder for the duration of the study and for the designated regulatory time requirement (i.e., FDA, ICH/GCP) post study.
   • For CTEP-sponsored studies, copies of documents are acceptable.
3. Ensure that all documents in regulatory files/binders are maintained in a secure, limited-access location and are kept confidential to ensure conformity to principles of confidentiality and human subjects protections.
4. The following documents (all versions) should be collected and filed in the regulatory file/binder if applicable to the clinical trial: (ref: ICH/GCP):
   • Investigator’s brochure
   • Blank case report forms
   • Information given to trial subjects
   • Financial aspects of the trial
   • Signed agreements between parties (i.e., sponsors/investigators)
   • Institutional Review Board (IRB) correspondence
   • IRB-approved informed consent forms
   • IRB-approved protocol amendments
   • IRB membership roster
   • Interim/annual reports to the IRB
   • Regulatory approval or authorization
   • FDA form 1572
   • Investigator and associate investigator CVs
     • Note: Licenses of investigators and associate investigators can be found in the CC credentialing office as well as in the regulatory binders.
   • Laboratory certification
   • Range of normal values for reference laboratory
   • Decoding procedures for blinded trials
   • Sample of labels attached to investigational product containers
   • SAE reports and IND safety reports including cover memos to the IRB
   • Subject Inclusion/Exclusion or Screening Log
     • Note: Patients who sign a consent for the protocol screening should be included in the Screening Log.
   • Subject Identification Code list
   • Signature list
   • Record of retained tissue or fluids samples, such as "Request for Human Biological Materials, Tissue Procurement & Transfer Form" (NIH-2803-1)
   • Results of site visits
   • Final study report(s)
   • Sponsor correspondence
   • Relevant communication other than site visits (letters, meeting notes, etc.)
   • Drug Accountability Forms: While study is open, all drug accountability documents will be retained in the Department of Pharmacy Services. When study is closed, all drug accountability documents will be retrieved and filed in the study regulatory binder.