Center for Clinical Investigation

As of October 15, 2009 the new Harvard Catalyst protocol review system has been activated.  Investigators will now be able to submit an electronic application for resources at ANY, or MULTIPLE, Harvard Catalyst Human Research Centers, including the Brigham and Women’s Hospital’s Center for Clinical Investigation (CCI) by using one common Resource Request Application.  Effective immediately, this system will replace the old GCRC Resource Request Application.  All applications currently under review will be completed using the old format, but all new applications will be completed using this new system.

A new Harvard Catalyst Human Research Center Review Committee has also been formed and all scientific review will be done by this committee.  Scientific review has been streamlined as well.

Protocols that are NIH funded or peer-reviewed with a summary statement (i.e. foundation and some TDN’s) will bypass the scientific review by submitting a copy of the Summary Statement Sheets and NIH Score, along with a functional protocol. 

Industry, multi-center, and consortium protocols will receive an abbreviated review and will be scored on an “accept/reject” basis.

Investigator-initiated protocol submissions, funded or unfunded and without previous peer review must include a letter from a biostatistician stating that he/she has reviewed the project and finds it acceptable.

To apply, please go to:

 https://review.pcir.catalyst.harvard.edu

You will need a Harvard eCommons username and password to access the system.  Additionally, all of your investigators and co-investigators will need to have a Harvard eCommons name.  These are usually issued very quickly (a matter of minutes, however could take up to one day.)  To register at eCommons, please go to:

 http://ecommons.med.harvard.edu

Once you have completed the Resource Request form, you will be asked to upload your IRB documentation; and any additional materials pertinent to your application (sponsor protocol, investigational drug brochure, etc.).

Resource review will occur prior to scientific review.  Total time for complete review of your application should not exceed 15 working days.

As this is a new process, we anticipate that there will be a learning curve.  If you would like assistance with filling out your resource request application, one of our Resource Facilitators will be happy to sit with you and assist with preparing the application.  Please e-mail cci@partners.org with any questions or concerns; or to set up a meeting with a Resource Facilitator.