Amendments, Suspensions, Terminations, and Extensions

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For interim changes to the trial, you'll need to send your program officer certain documentation. For example:

• Amendments or changes to the protocol, identified by version number or date. Except in the case of imminent danger to participants, your IRB or IEC must approve changes before they are implemented.
• Changes in informed consent documents, identified by version number or date. The IRB or IEC must approve changes before they are implemented.
• Temporary suspension or permanent termination of patient accrual.
• Temporary suspension or termination of the protocol.
• Change in IRB or IEC approval status.
• Other problems or issues that could affect participants.

Talk to your program officer to confirm what documentation is required.

Notify your program officer by fax or email within three working days of these events; then follow up with a detailed letter signed by you and your institutional business official, and include copies of relevant communications with the IRB or IEC.

If a delay occurs due to circumstances beyond your control, you may be eligible for an administrative extension. See our Investigator-Initiated Clinical Trial Administrative Extensions SOP and Investigator-Initiated Clinical Trial Administrative Extensions questions and answers.

Additional Resources

• Human Subjects Certifications: IRB or IEC SOP

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