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CCTSI > Research Resources > CTRCs > Protocol Submission
 

Scientific Advisory & Review Committee (SARC) Protocol Submission

SARC is a committee of experienced investigators, biostatisticians, and others. The purpose of this committee is to evaluate the scientific merit of research protocols utilizing CTRC resources.

To Access CTRC Resources

Note: Please do not submit to SARC and COMIRB simultaneously. This will cause a delay in approval for your protocol. Submit to SARC first.

Industry supported clinical trials do not undergo SARC review. Follow the instructions for Industry Supported Protocols on the right (CTO protocol submission).

To submit a protocol to SARC, please click on the link to the right that best describes the location where the study will be conducted. The link will provide detailed instructions regarding the specific submission process.

Once a protocol has been submitted to SARC, it will be routed through the appropriate review process, either Expedited Review or Full Review. Please note that the submission process is the same for both types of review processes. After the protocol has been submitted, the investigator will be notified as to which process it will be routed though.

Two Processes for SARC Protocol Review:

SARC Expedited Review

Eligible protocols must meet all criteria:

  • A multi-site clinical trial
  • Non-Industry supported protocol
  • Peer-reviewed for scientific merit by the sponsoring agency (e.g. NIH, DOD, foundations)
  • Has a detailed Statistical Analysis Plan
  • Has oversight by an independent Data and Safety Monitoring Board or the equivalent (e.g., NIH monitoring committee)
  • Has a finalized Research Protocol that cannot be changed

Protocol review is conducted electronically by a SARC co-chair, a biostatistician, and the Research Subject Advocate. Review is typically completed in 7-10 days.

SARC Full Review

  • All protocols that do not qualify for SARC Expedited Review require SARC Full Review

Protocol review is conducted by two scientific reviewers and a biostatistician and is presented to the full SARC review committee.

SARC meets twice per month.

Click on the button(s) to the right that represents the CTRC site where you will be conducting your research.

 
 

Investigator and Non-Industry Sponsored Protocols

UCH Protocol Submission Information

Children's Colorado Protocol Submission Information

Perinatal CTO Protocol Submission Information

NJH Protocol Submission Information

UCB Protocol Submission Information

Industry Initiated Protocols

UCH CTO Protocol Submission Information

 Contact Us

Ade Benson Email
SARC Protocol Submission Coordinator
720.848.6661