FORMS-G Changes to be Reflected in Human Subjects Clinical Trials Form on February 10 – Action Required by UsersFollowing a release on Thursday, February 10, 2022, the NIH 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:
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 necessary because, as NIH transitions 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. To re-save Study Records for an application:
3. Click one of the “Save…” buttons at the bottom of the screen. You need make no change, but the study will save in the newer format. If an error is encountered, you might need to open an Inclusion Enrollment Report (listed under question 2.9) and re-select a country from the Enrollment Country(ies) drop-down list; see Figure 2. New Country Codes New country codes appear in the Enrollment Country(ies) field on the Inclusion Enrollment Report. For general information on FORMS-G changes, see High-level Grant Application Form Change Summary: FORMS-G. electronic Research Administration (eRA) Need Help? Submit a web ticket; or call Toll-free: 1-866-504-9552, Phone: 301-402-7469. The Service Desk hours are Mon-Fri, 7 a.m. to 8 p.m. ET. |