Essential Documentation


Your clinical trial material will consist of many essential documents. These documents demonstrate the compliance with the standards of Good Clinical Practice and with all applicable regulatory requirements. Essential documents should be organized in a regulatory binder with tabs dividing each category. Essential documents should be gathered at the time of study initiation, maintained until the study is complete, and periodically reviewed for completeness. The original and all updated versions of the documentation must exist.

Required Essential Documents

The list below does not include the additional regulatory documentation requirements for Sponsor-Investigator studies. Sponsor-Investigator checklists are available on the Office of Compliance website

  1. All versions of the investigator’s brochures (drug trials) or device manuals (device trials) and updates
  2. All versions of the protocol and sample case report forms
  3. All versions of information given to subjects, such as
    • Informed consent forms,
    • HIPAA authorization forms,
    • Questionnaires and diaries, and
    • Recruitment and retention materials
  4. Financial aspects of the trial, such as
    • Emory University eCOI summary,
    • Sponsor conflict of interest (COI) forms or FDA Form 3455, and
    • Clinical trial budget and prospective reimbursement analysis (PRA)
  5. Signed agreement between involved parties, such as
    • FDA Form 1572 (drug trials) or Investigator Agreement (device trials),
    • Fully executed clinical trial agreement, and
    • Contract research organization agreement
  6. IRB approval letters for initial approval, amendments, continuing reviews, and reportable events
  7. Curriculum vitae or other relevant documentation evidencing qualifications of study team
  8. External laboratory contact information
  9. Normal values/ranges for laboratory or medical procedures included in the protocol
  10. Certification, accreditation, or other quality control mechanisms for all medical/laboratory/technical procedures/tests included in the protocol
  11. Sample of labels attached to investigational product packaging
  12. Instructions for handling the investigational product and trial-related materials
  13. Shipping records for investigational products and trial-related materials
  14. Decoding procedures for blinded trials
  15. Monitoring reports
  16. Notification of sponsor to investigator of safety information
  17. Subject enrollment log
  18. Investigational product accountability log
  19. Delegation of authority log
  20. Records of retained fluid/tissue
  21. Training logs
  22. Correspondence

Going Green

Study teams with multiple studies may find it difficult to keep essential documentation updated for all studies. One option is to have central binders to maintain department-specific essential documentation with a note in the study regulatory binders that references the location of the central binders.  Central binders work well for CVs, licenses, CITI certification, departmental training, and certification and normal ranges for frequently used laboratories. Central binders may also be stored electronically on a departmental shared drive that is easily accessible for all study staff for QA checks or audits. 

Study-specific essential documentation (e.g., IRB approval letters and protocols) must be maintained in a study-specific regulatory binder or folder on a secured shared drive.

References

International Conference of Harmonization, Efficacy Guidelines, Good Clinical Practice