Philadelphia University + Thomas Jefferson University

Essential Study Documentation

As part of the Quality Improvement Program, the OHR offers assistance in the creation and maintaining of study/regulatory and patient binders for clinical research studies. While the Quality Improvement Team is more than happy to meet with and assist any study personnel in their documentation methods, the OHR has provided all the tools needed to create your own binder using the documents below. Documents for both study/regulatory and patient binders have been provided.

Click Here for: Instructions for Creating an Essential Documentation Binder

Study/Regulatory Binder Documents

Document Description
Divider Tabs The divider tab inserts needed for the binder
Binder Section Descriptions A sheet for each section indicating what should be stored in that section
Screening and Enrollment Log List of all screened/enrolled subjects
Delegation of Responsibility Log List of responsibilities assigned to each team member
Biological Specimen Tracking Log (De-identified) De-identified tracking log for biological specimens
Biological Specimen Tracking Log (Identifiable) Identifiable tracking log for biological specimens
Protocol Deviations/Violations Log List of protocol deviations/violations
Unanticipated Problems Log List of unanticipated problems

Patient Binder Documents

Document Description
Patient Binder Contents Sheet List of some patient binder contents
Informed Consent Checklist Checklist to help document all aspects of the consent process
Investigational Product Accountability Log Documents test article dispensation and return
Documentation of Subject Unblinding Documents when a subject's treatment must be unblinded
Adverse Event Log List of adverse events