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Managing Study Documents After Approval
How to manage your study documents
There are a number of tools and templates to guide you in creating and maintaining good study documentation at IU.
Approval documents for IRB protocols
IRB approval documents vary based on the type of your submission and the level of review needed. All submission approvals are documented by an approval letter or formal email notification.
Instructions for locating approval documents in Kuali Protocols and downloading a copy for your research records can be found in the Kuali Protocols instructional guides.
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:
Adult subject, Consenting for Self (Accessible 07/22/19)
Adult subject, Cannot Consent for Self (Accessible 07/22/19)
Parent/Guardian Consenting for Minor Subject (Accessible 07/22/19)
Subject Re-consent (Accessible 07/22/19)
Screening and Enrollment Log Template (Accessible 04/12/21)
Eligibility Source Worksheet Template (Accessible 07/03/19)
Vital Signs Source Worksheet Template (Accessible 04/12/21)
Subject Off Study Source Worksheet Template (Accessible 04/12/21)
Concomitant Medication Log Template (Accessible 07/03/19)
Adverse Event Log Template (Accessible 07/03/19)
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)
Note to File Template (Accessible 07/22/19)