What is PRMS?
The University of Colorado Cancer Center is a designated National Cancer Institute Cancer Center. We have received national distinction, in part, due to the PRMS process which gives support and authority to the scientific research conducted at our institution
and our consortium partners.
The NCI mandates that all oncology clinical trials be submitted to the PRMS for review of scientific merit, priorities and progress prior to IRB review. As such, the PRMS has the authority to approve protocols that demonstrate scientific merit
and support our institutional mission as well as close trials that do not demonstrate scientific progress. The PRMS has established standardized processes and procedures for implementing these obligations per the NCI guidelines.
The PRMS provides the initial scientific evaluation of all oncology related protocols as well as ongoing review of any amendments or revisions to the protocol. We require scientific review to ensure not only the scientific integrity of the study but also
the feasibility and prioritization of the study, as it relates to our institutional mission and resources. All protocols with a cancer focus, regardless of type of review, must be submitted to PRMS.
New Protocol Submissions:
Any protocol whether industry sponsored, cooperative/national group or PI-initiated MUST be reviewed by PRMS prior to IRB review and/or approval. Click here to
review document requirements and instructions for submission. Each new submission must include the following documents:
- Final protocol
- Investigators Brochure (if applicable)
- Disease Site Schema
- LAPS form (if applicable)
- Signed PI Involvement page
- Signed Disease Site Leader and PI page
- PRMS Submission form
In addition to the PRMS submission form, the HSR Portal form must also be completed in order to consider your submission complete. HSR Portal access can be found here.
Both forms will need to be completed by noon on the deadline date to be considered for PRMS review.
NOTE: All incomplete submissions will be returned to the clinical research manager and not included on the next PRMS agenda for review. Studies that appear to compete for the same patient population must be indicated on the submission form. If not listed with a justification provided, the submission will be returned.
When Do I Submit To PRMS?
The PRMS meets the first Monday and third Wednesday of every month. Please see the PRMS Meeting Dates posted in the tab above for a current list for a current list of
our meeting dates and the due date(s) for new submissions.
The deadline for new submissions is 5:00 pm on the submission due date.
Remember to also complete the HSR Portal form.
What Happens Once I Submit My Protocol Application Packet To PRMS?
- PRMS staff will review the application for completeness
- The protocol is entered into OnCore and assigned a PRMS number
- The protocol undergoes pre-review by PRMS Chair and staff members
- The protocol is entered onto the PRMS agenda and routed for the following reviews:
- PRMS Full Board: Interventional studies
- PRMS Expedited Review: non-interventional studies, Chart reviews, Tissue Bank & Observational, National/ Cooperative groups, etc.
What Happens After My Protocol Has Been Reviewed By The PRMS?
Your protocol will be voted on by the Scientific Review Committee for Full Board reviews, or PRMS Chair for Expedited Reviews, with one of these outcomes:
- Approved
- Approved with Stipulations – clarification requested by reviewers
- Approved with Modifications – changes to the protocol must be considered before approval can be granted
- Disapproved – protocol is not permitted to be conducted. Major modifications are likely needed for approval and full re-submission is required
PRMS will communicate with you and your team via email if further action is necessary
Once approved, an approval letter will be sent to the PI, team manager and regulatory coordinator, indicating that the PRMS has reviewed your study and approves it opening at our institution. At this time you can move forward with your submission to the
IRB.
Is There Any Further PRMS Involvement Once My Protocol Is Open?
YES! The PRMS will oversee amendments and accrual to your study until it is closed.
- Amendment Review
- The PRMS is responsible for reviewing protocol amendments and revisions. All amendments must be submitted to PRMS. Depending upon the type of change, the amendment will undergo either Administrative Review, Chair Review or Full
Board Review.
Submit amendments in the PRMS Portal here. You must be using campus VPN to access the PRMS Amendment Portal
Low Accrual
PRMS evaluates low accruing interventional studies quarterly. You will receive notification if your study is considered to be low accruing. Either you and/ or your PI must respond to these notifications.
Underrepresented Populations
As mandated by the NCI, PRMS evaluates newly-submitted clinical trials for the potential for accruing minority and underrepresented populations from our catchment area (Colorado). Once studies are opened, the NCI requires continued monitoring to evaluate accrual of these specific populations. PRMS provides demographic data enrollments periodically to Disease Based teams regarding race, ethnicity, gender, age and rurality. The goal is to increase awareness of the demographic make-up of enrollees into cancer clinical trials, and to work in conjunction with the Office of Community Outreach and Engagement to assist teams in reaching the goal of matching the demographics of enrollees to our catchment population.
