Jefferson Office of Human Research Protection
Essential Study Documentation
As part of the Quality Assurance Program, JOHRP offers assistance in the creation and maintaining of study/regulatory and patient binders for clinical research studies. While the Quality Assurance Team is more than happy to meet with and assist any study personnel in their documentation methods, JOHRP 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.
Study/Regulatory Binder Documents
| Document | Description |
| Divider Tabs (DOC) | The divider tab inserts needed for the binder |
| Binder Section Descriptions (DOC) | A sheet for each section indicating what should be stored in that section |
| Screening and Enrollment Log (DOCX) | List of all screened/enrolled subjects |
| Delegation of Authority Log (DOCX) | List of responsibilities assigned to each team member |
| Biological Specimen Tracking Log (De-identified) (DOC) | De-identified tracking log for biological specimens |
| Biological Specimen Tracking Log (Identifiable) (DOC) | Identifiable tracking log for biological specimens |
| Training Log (DOCX) | List of training completed by team members |
| Unanticipated Problems Log (DOCX) | List of unanticipated problems |
Patient Binder Documents
| Document | Description |
| Patient Binder Contents Sheet (DOC) | List of some patient binder contents |
| Informed Consent Checklist (DOC) | Checklist to help document all aspects of the consent process |
| Investigational Product Accountability Log (DOC) | Documents test article dispensation and return |
| Documentation of Subject Unblinding (DOC) | Documents when a subject's treatment must be unblinded |
| Adverse Event Log (DOCX) | List of adverse events |