Managing Study Documents After Approval

KC IRB electronic stamp on informed consent forms

The Kuali Coeus IRB will apply one of several versions of an electronic stamp, depending on the status of your protocol. Electronic stamps will appear as follows:

  • For studies Open to Enrollment: Protocol 1501429309 IRB Approved
  • For studies Closed to Enrollment: Protocol 1501429309 IRB Approved for re-consenting only
  • For studies in Data Analysis Only: Protocol 1501429309 IRB Approved — Do Not Enroll Subjects
  • For disapproved studies: Protocol 1501429309 Disapproved
  • For expired studies: IRB Approval of Protocol 1501429309 Expired DD-Month-YYYY
  • For closed studies: Protocol 1501429309 Closed

The electronic stamp will be applied by KC IRB to any unsecured PDFs on the Notes & Attachments tab. Your informed consent form must remain unsecured. Other PDF documents that do not require a stamp should be secured. Study teams are encouraged to secure any PDF documents that do not require a stamp prior to uploading to KC IRB. Per Human Subjects Office policy, the only document that requires an electronic stamp is the informed consent form.

The electronic stamp is applied by KC IRB when the document is viewed and downloaded. The correct stamp, per protocol status, will be applied to the current informed consent form each time it is viewed.

If you view documents from the Notes & Attachments tab within a Renewal or Amendment submission (i.e. followed by A00X or R00X), any unsecured PDF not affected by the amendment or renewal will be marked with a stamp that reads “Invalid copy – not being modified with this Amendment or Renewal.” Final approved study documents should always be retrieved from the Notes & Attachments tab of the main protocol.

To protect PDF files in Office applications for Windows:

  • Click the Create PDF button in the Acrobat task ribbon.
  • Type a file name and select Restrict Editing.
  • In the Security dialog box that opens, set up a password and permissions as desired.
  • Click OK, and then click Save.

The Kuali Coeus IRB electronic stamp does not include approval or expiration dates, so it is very important for study teams to use version dates and/or version numbers. 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.
  • The KC Electronic Stamp Presentation provides additional details.
  • Important: note the version date or version number in the Description field on the Notes & Attachments tab in KC IRB each time a document is uploaded or 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

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

Demographics Source Worksheet Template

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

Medical History Source Worksheet Template

Physical Examination Source Worksheet Template

Vital Signs Source Worksheet Template

Telephone Contact Source Worksheet Template

Subject Off Study Source Worksheet Template

Concomitant Medication Log Template (Accessible 07/03/19)

Adverse Event Log Template (Accessible 07/03/19)

Serious Adverse Event Log: Per Protocol Template

Serious Adverse Event Log: Per Subject Template

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

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