Protocol Modifications
Throughout the course of the study, the protocol may be modified. Modifications may include addition or discontinuation of study procedures, changes in investigational product administration, revision of study visit schedule, and others.
When a protocol modification is planned, there are certain activities that need to take place. This page provides answers to some commonly asked questions regarding protocol modifications. For additional guidance or questions, please contact OCR Regulatory via email at psom-ind-ide@pobox.upenn.edu.
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For some studies, an individual might be both the PI and the (Regulatory) Sponsor. In this case, both sets of responsibilities mentioned apply.
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Sponsor
For some studies, an individual might be both the PI and the (Regulatory) Sponsor. In this case, both sets of responsibilities mentioned apply.
When updating the protocol, the Sponsor must ensure that the modification is thoroughly reviewed; this includes both a safety review and a review of its impact on the study as a whole.
The following information may assist the Sponsor in this review.
- Risk assessment – provides guidance on how to assess, document, and mitigate the risk posed by a modification.
- Pharmacovigilance (PV) Work Instructions (WI) – when the study is modified for safety reasons, refer to the PV WI on how study documents may be affected
- Core Document Revision Checklist – utilize the checklist to ensure that all needed steps are followed after a study document has been modified. Other study documents may need to be updated along with a protocol modification (i.e. investigator brochure, investigational device application, Form FDA 1572, informed consent form, data and safety monitoring plan, CRFs, study manuals, etc.) For templates of these documents, please visit the Forms, Tools, and Templates library.
- Protocol Amendment Log – utilize the log to assist in clearly tracking different versions of the protocol, as well as their approval and, if needed, training dates.
- Revising the posting on ClinicalTrials.gov
- Addition of new vendors / service providers
An IND or IDE exemption may be affected by a protocol modification.
Please refer to the IND-IDE Exemption Risk Assessment Tool and contact OCR Regulatory via email at psom-ind-ide@pobox.upenn.edu for additional guidance.
The Sponsor is responsible for approving modifications to the protocol, and other study documents. This must be done prior to submitting documents to the FDA, if needed, and prior to the PI submitting to the IRB.
If there is an agreement with a funding company/agency, the Sponsor should ensure required steps for a protocol modification are followed (i.e. the funder may require review, may have timelines, etc).
If the Sponsor and PI are different, the Sponsor should obtain PI acceptance of the change via a PI Signature Page.
For submissions to the FDA, please see FDA Submissions and Lifecycle Management.
For submissions to the Penn IRB, please see the protocol modifications page on the IRB website.
Ensure everyone is informed of the protocol amendment. If training is deemed necessary, the Sponsor must provide training on the revised documents and document the training. A Protocol Training Log should be used.