Message previously sent on 12/16/2020
DF/HCC Research Teams and iRIS Users,
We are excited to offer enhanced navigation assistance to investigators and research staff to aid in the triage and coordination of amendments received when another submission is already in process within iRIS. Please carefully review the important information below.
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Why can't I submit multiple amendments on my own?
The safeguards and sequential review processes built into the iRIS system ensure the integrity and version control of a protocol's forms and documents. Therefore, having more than one amendment and/or initial submission in iRIS for the same protocol can cause numerous problems, including stuck submissions and accidental overwriting of document versions.
As a result, iRIS users must adhere to business rules that restrict the submission of multiple amendments or the submission of amendments while a new protocol application remains in process. However, we have heard loud and clear that additional flexibility is needed to allow for parallel submissions under the appropriate circumstances. As such, we have now hired DF/HCC iRIS Navigators to help facilitate the handling of multiple submissions and avoid these common issues.
What type of navigation assistance is available starting today?
As of today, requests for exceptions to the business rule (i.e., requests to submit an amendment in parallel) should be submitted to DFHCCiRISNavigator@dfci.harvard.edu for evaluation. In cases where an exception cannot be granted, the Navigators can take additional steps to help facilitate submission of time sensitive amendments for phase I and phase I/II protocols, since these have been marked high priority trials and ones that often have repeated and more frequent amendments. In the future, we hope to add resources and expand this enhanced support for other protocol types. Stay tuned!
Important! Please request navigation assistance prior to submitting an additional amendment in iRIS.
I just received an amendment, but there’s another submission pending in iRIS. What should I do?
As a reminder, amendments can be submitted in parallel with any of the following; no approval or navigation support is required!
- Continuing Review/Progress Report
- Administrative Modification
- Dose/Cohort Open/Closure Form
- Events
- Sponsor-Investigator Add/Open/Complete External Site
If there is an initial submission or prior amendment in iRIS, please evaluate whether the new amendment can wait for the prior submission to be activated. If the new amendment is time sensitive and cannot wait for the prior submission, please email DFHCCiRISNavigator@dfci.harvard.edu and provide the protocol number and a summary of the not-yet-submitted documents and changes.
Every situation is different. We will help you determine the quickest path to approval and activation depending on individual circumstances. In some cases, we may be able to help you merge submissions or avoid the need for an additional amendment altogether.
Can iRIS Navigators expedite SRC/IRB review dates or push reviewers to approve an urgent submission?
No. Study teams remain responsible for tracking the status of their submissions within iRIS and following up with reviewers based on expected turnaround times. Any questions related to SRC/IRB scheduling should be directed to OHRS@dfci.harvard.edu.
If you aren’t sure how to do this, we suggest you watch the recorded training on tracking submissions in iRIS available by clicking here.
What if I have other questions about iRIS?
iRIS users should continue to utilize the iRIS WIKI resources, local superusers, institutional clinical trials offices, and the Guide on Who to Contact found on the WIKI front page. Please do not contact the iRIS Navigators with general questions or requests for technical support.
Sincerely,
