Multiple Amendments

Site amendments in the Online Reliance System can now process independently and concurrently, allowing each site to work at their own pace.

• No more waiting for one site amendment to process before adding the next.
• No limit to the number of amendments in progress at a given time.

What this means for you.

Sometimes, including all study sites on an initial reliance request can result in a long wait to reach a determination. If you have a study with just a few sites, including them all on the original request might be the way to go. However, the submitter of the original request (usually the Overall PI or a member of the study team) can take advantage of several flexible options to help speed up the process:

• You may opt to include on the original request only those sites that you know are ready to go, and then add others by amendment as appropriate.
• For studies with 6 or more sites, you may decide to select just a few to include on the original request, and then add the other sites by amendment.
• For maximum flexibility, you might select a single relying site to include on the original request, and add all other sites via amendment, so that sites can enter into the arrangement when they’re ready, without holding up the overall request.

You can always decide to remove any sites that are not ready to enter a decision, allowing the rest of your request to process. Once the Reviewing IRB issues a reliance determination for the original request, you can use the amendment process to add any sites you may have removed.

The process is simple:

1. The individual who submitted the original request initiates the amendment process, providing details about each new site’s involvement in the study.
2. POCs at each new site indicate whether they are willing to rely on the Reviewing IRB.
3. The Reviewing IRB POC confirms their willingness to review and issues an individual determination letter for each new site.

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