This program offers guidance, oversight and support to investigators engaging in studies that are FDA-regulated investigator-initiated trials. Through the expertise of the team within the FDA program, investigators are able to conduct their studies while following the current FDA regulations. We provide resources for investigators prior to submitting their IND/IDE application to the FDA and through the completion of the IND/IDE.
VCU policy and procedures
- VCU policy: Reporting sponsor-investigator investigational new drug applications (IND) or investigational device exemptions (IDE)
- Submit your IND or IDE via the VCU FDA submission portal
- Read the VCU Faculty Held IND and IDE procedure handbook
VCU forms and checklists
- Plans to conduct a clinical investigation at multi-center, external study site
- Essential documents
- Financial interest forms for all clinical investigators
- Monitoring plan and standard operating procedure
- Regulatory binder checklist
- Sponsor instructions for completion of financial interests
21 CFR Part 11 compliant remote monitoring
A 21 CFR Part 11 compliant version of DocuSign has been obtained by VCU to facilitate remote monitoring of FDA-regulated research for documents outside of Epic. Instructions on how to obtain Epic access for your monitor.
In order to obtain access to this version of DocuSign, please complete the following RedCap training: DocuSign remote monitoring training
After completing the associated RedCap training, a user account will be created for you and you will be able to access the 21 CFR Part 11 Compliant version for remote monitoring. This version of DocuSign should only be used for purposes of facilitating remote monitoring.
- Account management instructions
How to create a monitor account, instructions for a monitor to complete the set up of their account and what to do if an account gets compromised
- DocuSign user instructions
How to send documents and how a monitor will view documents
For any questions regarding what this version of DocuSign can be used for, how to use the system or any difficulties, please contact Lauren Wallace and Jim Ward.
Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) network is comprised of regulatory affairs specialists and experts from regional institutions that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program. VCU is proudly a part of this network and this network is available as an additional resource.
Medical Dictionary for Regulatory Activities (MedDRA)
VCU has obtained MedDRA for investigators to use as a medical dictionary for their clinical trials. MedDRA’s goal is to provide a single standardized international medical terminology available which can be used to help evaluate data pertaining to medical products for human use. MedDRA aids in removing the need to convert data from one terminology to another to prevent the loss of data, improving the quality of data, providing consistency in terminology used and facilitating the exchange of data. VCU holds an institutional license that allows VCU investigators to utilize MedDRA for their studies. To obtain access, please reach out to VCU’s FDA program manager at email@example.com.