Is your study team participating in a multi-site study in which each site will undergo separate IRB review? If so, take advantage of the option to submit a “local protocol addendum” to add detail about the main protocol the main site sends you.
The IRB knows that asking for a correction or an addition to a centrally provided protocol is a long shot at best. However, these protocols designed for use at multiple sites may not contain all the information the local IRB needs. That’s where the “local protocol addendum” comes in.
This document, prepared by the local study team, can fill in the gaps and allow the IRB to approve the research at our site. Protocol addenda can address site-specific details including, but not limited to, the following:
- Specific local data sources. Medical records — ok, but are there any specific medical records systems you’ll use? Does your study team routinely have access to those systems? If not, how will you arrange for the appropriate access?
- Local data handling measures — how will the data be stored locally, labeled, shared with the main site? This information is required for the local site to determine if HIPAA requirements are met.
- Recruitment details — which of the multiple recruitment methods that may be listed in the main protocol do you plan to use? If the main protocol says the potential subjects will be approached in clinic, give us details about that process. Will the study team approach the potential participants?
The IRB’s protocol template provides a guide to the information the IRB needs to be able to evaluate a protocol. If, when you compare the main protocol to the template, you notice the main protocol doesn’t address some information, you can use the protocol template text as a guide to creating the protocol addendum. The protocol addendum doesn’t have to address everything in the full protocol template — only the information missing from the central protocol.
When uploading a protocol addendum to CLARA, please put it in a separate document stack from the central protocol. Use the document type “protocol” for a protocol addendum.