The Clinical Translational Research Centers (CTRCs) at UCH, TCH, NJH and UCB support clinical research with clinical inpatient and outpatient space, inpatient research beds, nursing support, and nutrition, and core lab services. To access CTRC resources, investigators become CCTSI members and submit their clinical protocol for review by the Scientific Advisory and Review Committee (SARC). Protocols must also be approved by COMIRB (or WIRB for industry-sponsored studies). The SARC review process gives investigators experience that may help them submit better-quality COMIRB applications, which in turn may result in faster approval.
If you are seeking statistical support only or informatics support only you may not need to submit a protocol to SARC. For further information on statistical support please contact John Kittelson (303.724.4364). For further information on informatics support please contact Tom Yaeger (720.848.6675).
The pediatric and adult SARC panels each meet once a month. Investigators must submit their protocol for review by the appropriate submission date. Each of the four CTRCs (UCH, TCH, NJH and UCB) has eligibility requirements and submission dates and processes detailed in the links to the right. The committee’s decision is sent to the investigator within one week of the SARC meeting.
Certain protocols may be eligible for an expedited “e-review.” An e-review protocol is reviewed by a Scientific Advisory and Review Committee (SARC) co-chair, biostatistics, bioinformatics, and the Research Subject Advocate. The e-review process takes place outside of the full SARC, and is therefore not scheduled to be heard at a SARC meeting.
Eligible protocols are multicenter clinical trials that:
- Have already undergone scientific design and internal and/or external review,
- Have an integrated statistical analysis design (by statisticians)
- Have an integral DSMP/DSMB
- Are funded by nonprofit organizations
Single or several center PI-awarded grants (such as K or R awards) with a clinical component will rarely qualify for e-review. However, if the protocol has an independent DSMP/DSMB and the PI can verify the protocol submitted to the CTRC does not differ from the NIH submission, consideration for e-review will be given.
***SARC Co-Chairs reserve the authority to send a protocol to full committee review even if all conditions above are met.***