12 May New Study Intake and Activation
On June 1, 2020, the SCCA, Fred Hutch and UW Medicine are jointly implementing a new REDCap study activation process to improve research startup. All Consortium and Fred Hutch non-oncology human subjects research (i.e., any study that would currently be entered into OnCore and/or SRAMP) will be impacted by this update.
The Fred Hutch, SCCA and UW are committed to reduce clinical trial start-up times with a target of 100 median calendar days. To achieve the 100-day goal, we implemented a tri-institutional Clinical Trial Process Improvement (CTPI) effort to design, implement and measure improved processes. As part of the CTPI effort, a streamlined study intake, activation, and amendment process utilizing a REDCap-based submission workflow will go-live June 1st.
The REDCap platform will leverage more efficient methods of managing study information and documents during study startup and amendments. It allows for a web-based submission process with built-in logic and the ability to upload study-related documents to the system. The REDCap form replaces the existing Study Review and Management Portal (sRAMP) and impacts how study staff will interact with OnCore. In addition to expediting study startup, the new intake and activation process will support the implementation of OnCore financial functionality starting in 2021.
What studies are impacted by this process?
All consortium and Fred Hutch oncology and non-oncology human subjects research (i.e., any study that would currently be entered into sRAMP and/or OnCore).
What processes will be impacted?
- Creation of new protocols in OnCore
- sRAMP submission
- UW and SCCA coding and pricing
- SCCA compliance review of billing grid
- RG activation process
- Open to Accrual process in OnCore
What is changing?
- Project teams submit a REDCap Intake form to initiate the creation of a new protocol record in OnCore
- sRAMP submission replaced by a web-based REDCap Intake form
- RG code generated automatically upon completion of the REDCap form
- A single billing compliance review performed by UW CTO
- Radiology Application and IDS form automatically generated and sent to service areas (if applicable to protocol)
- RG Activation and Open to Accrual activities triggered in OnCore via a task list
- The CTMS Program Office will open the protocol to accrual in OnCore
How do I find more information?
Staff can expect to receive additional information and guidance as we approach the June 1st go-live date. Project team members are scheduled to speak at the following events:
- May 27th, 12:00pm: Webinar demonstration of new REDCap Intake Form and impacted workflows for studies utilizing sRAMP, Q&A opportunities
- May 29th, 12:00pm: Webinar demonstration of new REDCap Intake Form and impacted workflows for non-sRAMP studies (OnCore only), Q&A opportunities
- June 2nd, 11:00am: Webinar demonstration of new REDCap Intake Form and impacted workflows for studies utilizing sRAMP, Q&A opportunities
With the support and partnership of faculty and study staff, the CTPI collaboration provides an opportunity to implement the transformational changes needed to realize our clinical trial startup goal. The roll-out of the new intake and activation process is an important and exciting step.
Questions regarding communications and the roll-out plan can be directed to Eli Reis at email@example.com.
OnCore-related questions can be directed to the CTMS Program Office at CTMS_Office@fredhutch.org.