RAMS Systems Policies Forms Events Contact Us

Lines background

Regulatory affairs

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.

Navigate
Drugs/Biologics
Devices
Compassionate access and emergency use
Reporting adverse events to the FDA
FDA guidance and regulations

VCU policy and procedures

VCU forms and checklists

Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)

Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) LogoThe 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)

MedDRA logoVCU 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 indide@vcu.edu.

MedDRA training tools are located here

Contact us

Lauren Kanigher, MS
FDA program manager
indide@vcu.edu