GCO Submission

We are pleased to announce a new, streamlined workflow for NEW Industry sponsored clinical trials that are managed by the FACTS Office. Effective for any new Industry trial submitted to PPHS after January 1, 2024, this workflow removes the requirement to submit these studies through Infoed.

Industry sponsored clinical trials with no competitive review process that have already been submitted to the GCO, please do continue submitting the non-competitive applications to the GCO through close out.

Industry funding where MSIP signs the agreement and all industry funding that is peer reviewed, including but not limited to SBIR/STTR subawards, continues to require GCO submission and review.

As a result of this change these clinical trials will no longer have a GCO number. These studies can leave the “GCO #” field blank in RUTH and eDMS.  Instead, the FACTS Office will create a unique study ID for each proposal that will serve the same purpose as the GCO number for fund creation and building studies in Epic. The study ID will be created using the number assigned automatically by the RUTH system and following the below rules:

• Drop the prefix ‘STUDY-‘.
• Convert the ‘2’ in the year to ‘B’.
• Drop the lead ‘0’ in the 5-digit sequential number after the year.

Example: STUDY-24-01234 = B4-1234

FACTS will discontinue manual creation of mock numbers for trials that are going to BRANY and instead create a study ID using the above rules.

The study ID will be logged in OnCore for study team reference. Please click here for detailed instructions on where to find the study ID in OnCore and for a detailed presentation about this process change.

For any questions/concerns please contact ORS via the Research 411 ticket.

In order to complete the GCO submission, the  Principal Investigator (PI) must approve/sign off on the InfoEd application.