Writing Your Amendment
Writing Your Protocol Amendment
In addition to helping investigators write their initial protocol, Protocol Development also provides support for writing amendments.
Protocol Amendment vs. an Administrative Letter
There are two ways to change your protocol: a protocol amendment or an administrative letter.
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A protocol amendment would be used in an instance in which objectives, eligibility, treatment, or study design or other scientific changes need to be made. For instance, if you wanted to add an alternative treatment regimen, change your primary objective or add a new population to the study, these would constitute changes that would require an amendment.
Administrative letters serve as notifications for a clarification to ensure the correct intent of the protocol without diving into a full amendment. These changes are typically considered administrative in nature and may be used for clarifications, PI changes, or even in some cases, study closures. For instance, if in the Time & Events Table, serum chemistries list LDH to be tested and in the Laboratory Assessments section this test is not included. A letter may be issued to clarify if whether or not LDH was needed. Administrative letters used for active protocols are eventually incorporated fully into the protocol when a full amendment takes place.
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What To Expect
Amendments can be requested by anyone from the study team. Generally, it is the decision of the Principal Investigator (in lieu of additional guidance from funding sources or other regulating bodies, for example) as to whether a protocol amendment is needed, though there are some guiding principles used to assist in that decision making process as described above. The time it takes to complete an amendment can be highly variable; however, depending upon the type of protocol it may take anywhere from 2-6 months.
The Process
Changes are made to the protocol in track changes and logged on an Amendment Coversheet. Once the amendment is fully drafted it is reviewed by the study team and then subsequently “finalized” and ready for review by the official reviewing bodies. Depending up on the nature of the protocol and the amendment, the reviewing bodies involved may be the funding source, the PRC, and/or the FDA prior to “release” of the amendment and consent to the Regulatory team for IRB submission and review. One may expect approximately 1 month for each reviewing body to complete their review, but it may take longer depending upon the feedback or need for additional changes upon review.
Whether your protocol may require PRC review depends on the nature of the protocol changes. Typically, changes that affect the scientific nature of the protocol will need to be reviewed by the PRC. Examples include a change in the primary objective, adding a drug to a therapeutic regimen, or changes that affect the statistics of the study. Additional information may be found on the PRC website.
For additional resources you may refer to the following standard operating procedures (SOPs):
Amending Protocols
Administrative Letters