Skip to content

e-Regulatory Binder & eDoA (Audit Prep)

What this page tells you

How to build and audit-proof the electronic regulatory binder: Box template link, required personnel documents (CITI Biomedical, CITI GCP, HIPAA, CV, license, protocol training acknowledgement), eDOA in REDCap, and the email template to send PIs before the Collaborative Protocol audit.

Templates to set up electronic regulatory binders for studies: https://upenn.box.com/s/ucqxqd1v5dpirvd138tqx0in96clco29

Use the outline below when creating the e-reg binder for all IRB studies

Collaborative Protocol 821778: Audited 9/11

  • Click here for the Electronic Regulatory Binder (for the collaborative study)
  • Before the audit, ensure all personnel on the study have the following documents:
    • Folder Name in pennbox reg binder (position-first name_last name)
    • CITI Biomedical Research - Human Research (no expiration)
    • CITI Good Clinical Practice (expires every 3 years)
    • Current HIPAA (expires annually)
    • Current CV
    • Medical license (if applicable)
    • Protocol training document (redone whenever there is a new protocol version)
      • Send everyone the current protocol and the site training acknowledgement (template below; be sure to update with the current version #)

📄 Protocol_Training_Acknowledgement_v13.pdf

    • Make sure all protocol versions and ICF versions are also in the "study documents" → "A-Protocol" or "B-Informed Consent&HIPAA Authorization" folders
    • If the study has a device, add all device manuals in "study documents" →"D-Device Manual"

  • Electronic DOA

Instructions to Email to PIs before

Hi everyone,

As you know, the (YEAR) Audit for the Collaborative Protocol 821778 is set to start (START DATE)! Please read the email below and get started on this process. 

Please check your lab's folder in the electronic regulatory binder to ensure all personnel is up to date and that each person's folder contains all of the documents listed below (Find the e-reg binder here: https://upenn.box.com/s/qimg8alsm4snlndgq7avm54ioxdldtss)

You are responsible for uploading your documents into PennBox. We ask that all documents be loaded into PennBox by (DATE). We will send out reminder emails as the (DATE) deadline approaches, but we will not be reminding individuals to get their documents in. If you do not have all your documents in by (DATE), we will remove you from the protocol before the start of the audit.

Once all of the documentation for your lab is complete, please let us know. As a reminder, the electronic delegation of authority log is kept in REDCap. All personnel added to the protocol are then added to the DOA. The individual, their PI, and the PI of the study (Kate) will all need to sign off when they are added.

If any of your trainings are due to expire during (DATE OF AUDIT), please redo them.
Documentation Required-

  • Folder Name in pennbox reg binder (position-first name_last name)
  • CITI Biomedical Research - Human Research (no expiration)
  • CITI Good Clinical Practice (expires every 3 years)
  • Current HIPAA (expires annually)
  • Current CV
  • Medical license (if applicable)
  • Protocol training document (current version)

Instructions for Obtaining Trainings-https://upenn.box.com/s/bwjk5cr1d3b8r52dba0sc1pvkj5sl71s