Note: If your study will be conducted at National Jewish or Boulder campus please follow the links on the bottom of this page to contact them for the protocol form and submission process.
COMIRB has recently revised their application forms. The GCRC application form is no longer in use.
We recommend the steps listed below to ensure that your new protocol submission is reviewed and approved in a timely manner.
IMPORTANT NOTE:
- All investigators must now apply using the newly revised COMIRB forms .
- Protocols conducted on the GCRC must be reviewed by the Scientific Advisory Committee (SAC). Final COMIRB approval is contingent upon receipt of the final GCRC/SAC approval letter.
GCRC PROTOCOL SUBMISSION STEPS: [download a printable version of these instructions]
Design and plan the study.
- Meet with a biostatistician to discuss scientific and statistical issues.
- Meet with the RSA to identify safety monitoring needs (e.g., self-monitoring, Safety Officer, DSMB) and to develop a Data and Safety Monitoring Plan (DSMP).
- GCRC policy on Risk Assessment
- GCRC policy on DSMPs
- To ensure the study can be accommodated on the GCRC, you should contact the GCRC Administrator and any GCRC core service that will be heavily utilized by the study.
[GCRC contacts]
- Complete and submit the COMIRB application and all attachments for SAC review. Attachment W must be included.
Your application must comply with the requirements of both the GCRC and COMIRB.
[SAC submission instructions]
[SAC meeting deadlines]
[COMIRB Application downloads]
- Investigators are invited to participate in the SAC review process.
- Once reviewed by SAC, prepare and submit initial review packets to COMIRB.
- The GCRC protocol application should be submitted to COMIRB in place of a protocol/protocol summary.
- The consent form should contain the standard language for GCRC studies in the Invitation for Questions section, as demonstrated on the COMIRB Consent Template.
[Download COMIRB forms/templates]
- Submit materials for HRRC review.
For "A" and "B" studies
to be conducted on the GCRC, the HRRC process will be coordinated by the GCRC Administrator. Investigators are required to submit only the following documents to the GCRC(Campus Box B-141, Attn: Tim Lockie)
- Cover letter requesting expedited HRRC review
- COMIRB-approved consent form
- HIPAA Authorization B
Investigators planning to conduct "D" studies on the GCRC must obtain HRRC approval in the usual manner.
[HRRC website]
- Obtain approval from other review committees (e.g., IBC, RDRC) relevant to the study.
*ERL studies: For studies utilizing the facilities at the Exercise Research Laboratory, please note that there are additional approval requirements (contact 303.315.6700).
- Participate in the PI meeting to finalize the details of how the study will be implemented on the GCRC.
Scheduling of the preliminary PI meeting is contingent upon approval by COMIRB, HRRC, and all other relevant review committees.
[PI meeting process]
- Once the study begins, all amendments must be approved by both COMIRB and the GCRC.
[Amendment procedure]
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