To submit your protocol to The Children's Hospital (TCH) CTRC, please follow the steps below:
Step 1: Verify that your protocol is eligible for CTRC support:
- Is the protocol industry-supported?
• If YES, your protocol is not likely to be eligible for CTRC support. Please contact Beth Esterl (720.848.6420; esterl.elizabeth@tchden.org) at the Clinical Trials Organization (CTO) to confirm.
• If NO, your protocol is likely eligible for CTRC support. Continue to Step 2.
Step 2: Consult with CTRC Protocol Manager (Elle Lothlorien at 720.848.6234; elle.lothlorien@ucdenver.edu) and with the following support (as applicable to your protocol):
- Bioinformatics
- Biostatistics
- Research Subject Advocate (RSA)
DSMP Guidance
- Nursing
- Bionutrition
- Core Lab(s)
Step 3: Access application documents at COMIRB website.
Step 4: Check submission deadlines.
All protocols requesting CTRC support must be reviewed by the CTRC Scientific Advisory and Review Committee (SARC). Submissions are due by the 4th Monday of each month in order to be put on the agenda for the SARC meeting on the 3rd Monday of the following month. Submission deadlines.
Step 5: Become a CCTSI member.
Step 6: Submit your protocol.
Email all protocol application documents from Step 3 to Elle Lothlorien (elle.lothlorien@ucdenver.edu), CTRC Protocol Manager.
Step 7: Examine the flowchart of the TCH CTRC protocol submission process.
If you have any questions about the status of your protocol please contact the CTRC Protocol Manager, Elle Lothlorien, at 720.848.6234 or elle.lothlorien@ucdenver.edu.