Managing Study Documents After Approval

Versioning your study documents

It is very important for study teams to use version dates and/or version numbers, particularly on informed consent documents, to ensure the correct version of documents are being used by all study team members. A few tips to remember:

  • Be consistent. Develop a naming and versioning convention to be used by all members of your study team.
  • Document your naming convention in your study files where all team members, monitors, and auditors can reference it.
  • Abbreviate standard document types to reduce the length of file names (e.g., Protocol = PRO, informed consent = ICS; assent = AST)
  • Include version dates/numbers in document footers and document file names.
  • Format dates consistently and choose a clear standard. Always include the year.
  • Be sure to update version dates/numbers in document footers each time the document is revised.  Updating version dates is required for informed consent documents and will be verified during the HRPP pre-review process.
  • Important: Include the version date or version number in the Description field in the Attachments section in Kuali Protocols and ensure it is updated each time a document is replaced.

Clinical research management templates

The template documents below are starting points and should be customized to accommodate the needs of your individual study. Some of the documents are not applicable to all studies, and the nature of some research may warrant additions or changes to these forms. Be aware, too, that some sponsors and agencies may require you to keep additional documents that are not provided here.

Prior to Study Initiation

Regulatory Binder Content Template (Accessible 04/12/21)

Delegation of Authority/Site Signature Log Template (Accessible 07/03/19)

During the Study

Informed Consent Version Log Template (Accessible 07/03/19)

Informed Consent Process Documentation Templates:

Subject Re-consent (Accessible 07/22/19)

Screening and Enrollment Log Template (Accessible 04/12/21)

Demographics Source Worksheet Template (Accessible 06/29/21)

Eligibility Source Worksheet Template (Accessible 07/03/19)

Medical History Source Worksheet Template (Accessible 07/06/21)

Physical Examination Source Worksheet Template (Accessible 07/06/21)

Vital Signs Source Worksheet Template (Accessible 04/12/21)

Telephone Contact Source Worksheet Template (Accessible 06/22/21)

Subject Off Study Source Worksheet Template (Accessible 04/12/21)

Concomitant Medication Log Template (Accessible 06/29/21)

Adverse Event Log Template (Accessible 07/06/21)

Serious Adverse Event Log: Per Protocol Template (Accessible 04/12/21)

Serious Adverse Event Log: Per Subject Template (Accessible 04/12/21)

Drug Accountability Log: Per Protocol Template (Accessible 07/03/19)

Drug Accountability Log: Per Subject Template (Accessible 07/03/19)

Device Accountability Log: Per Protocol Template (Accessible 07/03/19)

Protocol Deviation Log Template

Protocol Training Log Template (Accessible 06/22/21)

Note to File Template (Accessible 07/22/19)