Upcoming Changes Affecting Studies Involving CTSI CRS Centers or Services

Effective Monday, February 3, 2014, the following three changes affecting studies involving CTSI CRS Centers or Services will be implemented:

CRS Center Utilization Review form moving offline and out of iRIS

The online CTSI Clinical Research Services (CRS) Application appended to the CHR iRIS Study Application form will be decommissioned on February 3, 2014. After that date, when you submit a new study using CRS Centers or services, the iRIS system will send you an email including a link to the Clinical Research Services Budget Estimate Request Form, instructions on how to submit the form, and who to contact with questions.

Sequential Routing of New Studies in iRIS

iRIS was originally implemented to route new studies involving CRS Centers or services to both the CHR and the CRS Advisory Committees (CRSAC) for concurrent review. However, since January 2, 2013, all interventional clinical trials have been required to undergo Scientific and Feasibility Review prior to CHR review. Now, in many cases that the CHR must return CRS studies back to the study team pending completion of CRSAC scientific review, making concurrent routing inefficient.

Effective February 3, 2014 any new study submitted in iRIS that involves CRS Centers or Services will be routed first to the CRSAC, and after their review is complete, routed to CHR. If scientific review has already been completed by an external group (e.g., NIH), CRSAC will administratively review and forward the study to CHR on the same day whenever possible.

New Modification Form Question Screening for Addition of CRS Centers or Services

Also on February 3, 2014, a new question will be added to the Modification Form asking if the modification includes adding the use of CRS Centers or services to the study for the first time. This will help the CRS staff identify new requests easier so they can contact the study team and begin the utilization review process quickly.

Please contact Leslie Mullin at the CTSI CRS at 415-514-2292 with questions about these changes.

These changes will eliminate hand-offs and bottlenecks from the current process and CHR and CTSI CRS expect this will result in a more efficient process.