Research Pharmacy Workflow Updates
April 25, 2023
Studies Requesting Waiver of Services
Research Pharmacy (RP) has implemented a new workflow for studies requesting a waiver of services to improve the efficiency of the review process. For studies working with Clinical Trials Support Units (CTSU), the CTSU Portfolio Manager will facilitate this process. For studies not working with a CTSU:
- Studies requesting a waiver in section 15 of eResearch will also complete a Waiver Request Form (remote access requires VPN)
- Email the form to pharm-research-pharmacy-requests and include the following if not already provided:
- Protocol
- Investigator’s Brochure
- Pharmacy Manual
- The RP Portfolio Coordinator will set up a half-hour virtual consultation between the RP team and the study team
- RP decision will be communicated back to the study team and also posted to the study application in eResearch
Research Pharmacy OnCore Integration
- RP has integrated its administrative workflows into OnCore CTMS to enhance efficiency & transparency.
- Studies receiving RP support will have a management group called Research Pharmacy Service Utilization
- The following RP administrative workflows are now OnCore task lists:
- Study start-up
- Amendment
- Hazardous drug
- Audits
- Study closeout
- The study’s pharmacist will be listed on the OnCore Study Team
- New annotations have also been added to OnCore to accommodate RP data requirements.
FAQ Updates
Frequently asked questions about Research Pharmacy fees have been updated to address maintenance basic fees implemented in 2023. Read more here (remote access requires VPN) under, “When do “basic” maintenance fees apply?”
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Edited By: dagi@med.umich.edu
Last Updated: April 25, 2023