Essential Documentation

Clinical trial documents are referred to as “essential documents” in GCP. These documents demonstrate the compliance of the investigator, sponsor and monitor with the standards of GCP and with other applicable regulatory requirements. Essential documents should be organized in a paper or electronic binder, commonly referred to as a regulatory binder, with tabs dividing each category. Essential documents should be gathered at the time of study initiation and maintained until the study is complete.  Original and all updated versions of the documentation must be maintained.

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 Research Compliance and Regulatory Affairs 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 or electronic data capture manual
  3. All versions of information given to participants, 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 eDisclose 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 applications and associated approval letters for initial approval, modifications, continuing reviews, and reportable new information
  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 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. Participant enrollment log
  18. Investigational product accountability log
  19. Delegation of authority (DOA) log
  20. Records of retained fluid/tissue
  21. Training logs
  22. Correspondence

Electronic Regulatory Binders

The use of electronic regulatory binders (“eReg”) to store clinical trial essential documentation is becoming the norm as more teams move away from paper. The use of eReg allows study team members from multiple locations to access documents, investigators to electronically sign-off on documents, and the sharing of documents with sponsors and contract research organizations. Emory researchers can use Emory’s One Drive and Emory’s Microsoft Teams platforms to create study-specific eReg binders. Emory also allows the use of Complion, Veeva Vault, and Florence for eReg. More information on eReg platforms at Emory can be found here. Sponsors may also provide eReg from other vendors platforms.

Study teams with multiple studies may find it difficult to keep personnel-specific essential documentation (e.g., CVs, medical licenses, CITI certificates, and departmental training) updated for each regulatory binder. One option is to have central paper or electronic binders to maintain personnel-specific documents with a note in each study-specific regulatory binder that references the location of the personnel-specific central binders. 

The use of electronic DOA logs eliminates some of challenges of maintaining a paper log. Electronic DOA logs may include electronic signatures by the PI and study team members. Wet-ink signatures are required by GCP in the case of audit so that the auditor can verify signatures located on paper research records. Study teams utilizing electronic DOA logs can capture wet-ink signatures for each study team member by using a Signature Sheet. Signature Sheets can be maintained in the personnel-specific electronic binders.

References

International Conference of Harmonization, Efficacy Guidelines, Good Clinical Practice