eRA Information: FORMS-G Changes to be Reflected in Human Subjects Clinical Trials Form on February 10 – Action Required by Users
Wednesday, February 9, 2022
Following a release on Thursday, February 10, the Human Subjects System (HSS) will transition to using the FORMS-G version of the post-submission Human Subjects Clinical Trial (HSCT) form. HSCT forms will have new expiration dates and a new OMB number on the Inclusion Enrollment Report, as well as the following changes:
- New country codes, detailed here, incorporated in country drop-down lists on the Inclusion Enrollment Report form; see Figure 2.
- The label for question 3.2 will change from If yes, describe single IRB plan to Single IRB plan attachment. (Note, this field is currently required for AHRQ applicants only).
- .csv files listing large numbers of enrollees (over 100,000) can now be uploaded on the Inclusion Enrollment Report using the Upload Participant Level Data Attachment button.
IMPORTANT: Re-Save Study Records That Are in Work in Progress Applications
After the release date, but prior to application submission, users should re-save Study Records in Work in Progress applications (without necessarily making any changes). This is to update the underlying data to match the new FORMS-G version. This is because as we transition to the new FORMS-G version of the HSCT, any Work in Progress record will be migrated behind the scenes so users will need to save again before submitting the form.