Essential documents which include regulatory binders (also known as Study Admin File, Investigator Binder, Investigational Site File (ISF), or Study Binder) contain the study specific information and regulatory documentation in a centralized location. It organizes essential study documents and should be easy to access and auditable.
Contact OCR Regulatory for questions or assistance at PSOM-IND-IDE@pobox.upenn.edu
- Penn Reviewing Entities
- Study Documents
- Protocol/Protocol Amendments and supporting documents
- Informed Consent & HIPAA Authorization
- Case Report Form Sample
- Investigator’s Brochure /Device Manual
- FDA Forms as applicable – 1572, sample of labels, FDA correspondence, financial disclosures
- Lab Documents (CLIA/CAP)
- Study Tracking Logs
- Subject Logs (Screening/Enrollment)
- Adverse Event Reports
- Investigational Product
- Monitoring Visits and Logs
- Research Personnel
- Study personnel (CV, licenses, training, etc.)
- Delegation of Authority Log
- Unmasking Procedures for Blinded Trials
- Certificates of Confidentiality
- Other study documents as needed
It is preferable that the essential documents are maintained electronically, either through Penn Box or Veeva Vault, which both serve as options for electronic Regulatory Binders. Contact OCR for an eTemplate for maintaining the Regulatory Binder in PennBox.
OCR offers downloadable templates with instructions for maintaining regulatory binders on paper.
There are three different templates available within our forms, tools and templates library depending on the study type:
- Study Admin File_Device Template for developing a study administration file or regulatory binder for a device trial.
- Study Admin File_Social Behavioral Template for developing a study administration file or regulatory binder for a social behavioral study.
- Study Admin File_Drug Template for developing a study administration file or regulatory binder for a drug trial.
The sponsor essential documents are filed in what is known as the Trial Master File (TMF). The TMF is the collection of documents that will be requested in the case of audit, inspection, or litigation. It should begin at first inception of a trial when a protocol is being developed and vendors are being selected. The TMF should be maintained current and complete during the life cycle of the investigation and at least 2 years after last approval of a marketing application (if applicable) or otherwise in accordance with Penn Policy of 10 years.
Access to the TMF must be controlled and limited to authorized individuals with role-based access privileges. The storage system utilized for maintaining and archiving the TMF (irrespective of the type of media used) should provide information to tell the story of the trial. Standard procedures, such as a Trial Master File Plan, should be developed and shared with anyone who accesses the TMF to ensure the TMF has an organization that enables ease of review and document naming conventions that make documents identifiable by type, version, and history. The industry standard for documents to be retained in a TMF are outlined in the Drug Information Association (DIA) Reference Model. OCR also has a simplified TMF Template that includes key components of a TMF such as core study documents, FDA/regulatory communications, Vendor qualifications, Investigational product records, and database records. A system that allows for ease of search and retrieval is recommended for maintaining your TMF at Penn Medicine; such as Penn Box or Veeva eTMF. Note: TMFs on computers and shared drives are highly discouraged.