HRPP Toolkit: Protocol Templates
The VCU HRPP has made three protocol templates available at https://research.vcu.edu/forms/ to facilitate our transition toward a protocol-based application process. (If you receive an error message from this hyperlink, please copy/paste the address into your browser.)
- HRP-503 – PROTOCOL – submission of biomedical studies and clinical trials
- HRP-503a – SBS PROTOCOL – submissions not involving an investigational agent
- HRP-508 – SITE SUPPLEMENT TO SPONSOR PROTOCOL – provides VCU-specific information about research procedures and participant enrollment when there is an accompanying sponsor protocol
The protocol templates are immediately available to the VCU research community for the IRB submission of new human subject research studies. Formal protocols will be required for all human subject research submissions effective June 1, 2023. Thus, if the study sponsor does not provide a protocol, the completion and submission of the respective protocol template will be required. Please note: new IRB submissions that do not contain a formal protocol will be returned to the researcher to include a protocol after the effective date of June 1, 2023.
RAMS-IRB will be updated in the coming months to reduce duplication between the submission smartform and protocol template. The system will be more comprehensively updated later this fall – please be patient with us as we engage in this transformation work.
Questions are welcome, as are requests for additional consultation regarding new protocol templates. Please contact Tom Bechert of the Huron Team via bechertt@vcu.edu or the HRPP Office at orsp@vcu.edu. Learn more about the VCU HRPP’s transformation project and protocol templates here.
Categories Announcements and Updates, HRPP Transformation Project