Revised SAE & INDSR Reporting Policy and ICF Version Control Guidance - Effective March 17, 2025

March 17, 2025

Dear DF/HCC Community, 

Please see below for two updates from OHRS.

Revised SAE and INDSR Reporting Policy Posted, Effective Date March 17, 2025

OHRS has updated the current “Adverse Event Reporting” policy to provide more detail about Serious Adverse Event and IND Safety Reporting. The new policy, currently available in the document library, is titled, “Adverse Event and INDSR Reporting.” Please note that the policy was updated to clarify the timelines for reporting, including expedited reporting, and to describe in more detail the investigator/sponsor responsibilities consistent with FDA regulation and guidance.

The policy may be found here.

Important Reminder Regarding Amendments and Informed Consent Form Submissions

It is very important for Informed Consent Form (ICF) version control that the iRIS WIKI Instructions are followed when uploading edited documents for review into iRIS. The process described ensures that the latest approved ICF is being submitted with new revisions tracked. This process should be followed, as opposed to storing a copy of the ICF on a desktop and uploading from there as the latter increases the possibility that a previous version is used to make revisions, which may lead to potentially significant deletions to the consent form. The length of consent forms makes word by word comparisons difficult and time consuming for IRB reviewers. Uploading these documents correctly is essential to ensuring that the proper version of the document is reviewed by the IRB, and that no information or risks are inadvertently removed. Please do not edit and submit versions of documents saved on desktops and instead follow the iRIS WIKI instructions.

Please see the link to the iRIS WIKI Instructions.

In the future, ICF documents submitted in a different manner may be returned to the study team without review in order to follow the version control process.

Please see a recording of the March 12th Office Hours associated with these updates for more information, and contact OHRS@dfci.harvard.edu for any additional questions.