Radioactive Drug Research Committee (RDRC)

calexh-sar commented 3 years ago

Resources

Home wiki with handy links, testing and bug reporting tips
[Workflow wiki](https://github.com/sartography/cr-connect-configuration/wiki/RDRC Approval Letter)

Configurator

[x] Build workflow
[x] Wiki update

Configurator Reviewer

[ ] Logic
[ ] Script
[ ] Wiki review

Support

[ ] Main Dashboard
[ ] Study Dashboard
[ ] Form input
[ ] Email notifications
[ ] Text throughout
[ ] Wiki review
[ ] If needed, modify configuration of study in protocol builder mock to trigger alternate scenarios, and re-test

CTO Office

[ ] Final sign-off

calexh-sar commented 3 years ago

sms8yk commented 3 years ago

Please Note we are meeting with RDRC Stakeholders to discuss requirements on 4/12/21

sms8yk commented 3 years ago

FYI - We just met with RDRC and will be releasing an update to the step instructions in CRC1. The new Step instructions in CRC1 will be:

This step is Open when: -"IRB Review Type" Step is Complete and IRB Review Type is 'Full Board', 'Expedited', 'Non-Engaged' or 'Exempt'. -"Compliance Requirements Checklist (by IRB-HSR)" Step is Complete and the question "Radioactive Drug Research Committee (RDRC) Review" is 'Applicable'.

Compliance Requirement: UVA Radioactive Drug Research Committee (RDRC) approval is required for radioactive drugs and agents that are not approved by the FDA or are not being used under an FDA approved IND (Investigational New Drug application).

The RDRC program permits basic research regarding metabolism, physiology, pathophysiology, or biochemistry — it is not intended for therapeutic or diagnostic purposes or determination of safety and effectiveness.

Additional information and links to the RDRC application process may be found at http://ehs.virginia.edu/Radiation-Safety-RDRC.html

Process: Go to the website noted above and click on "RDRC's online application (log-in)" to start the RDRC application process. Upload an approval letter from the RDRC committee below and submit this step. The document attached here will be automatically included in the submission to the IRB-HSR for Pre-Review.

lfetcho commented 3 years ago

FMI: This is currently in UVA Compliance Reviews

ajski commented 3 years ago

Closing since this was absorbed in to UVA Compliance Reviews

sartography / cr-connect-configuration

Radioactive Drug Research Committee (RDRC) #25