ELEMENT I.8.D.
ELEMENT I.8.D.: Before initiating research, the organization has a written agreement with the sponsor about plans for disseminating findings from the research and the roles that researchers and sponsors will play in the publication or disclosure of results.
If the organization has a policy regarding the publication of findings from sponsored research and works directly with a sponsor or its agents, contracts or other funding agreements should require the sponsor to follow that policy and procedure.
This Element does not apply to the organization that does not directly work with sponsors or to the organization that has no policy regarding the dissemination of findings from sponsored research.
Regulatory and guidance references
Required written materials
- Essential requirements:
- Policies and procedures have contracts or other funding agreements require the sponsor to follow the organization’s policies and procedures regarding the publication of findings from sponsored research.
- When following VA requirements:
- For VA facilities:
- The appropriate VA Clinical Trial Cooperative Research and Development Agreement (CRADA) is used for research collaborations where
- The industry Sponsor holds the FDA investigational device exemption (IDE).
- The industry Sponsor holds the FDA investigational new drug (IND) application and developed the protocol.
- The VA PI has substantially designed the protocol for clinical studies.
Outcomes
- Contracts or other funding agreements require the sponsor to follow the organization’s policies and procedures regarding the publication of findings from sponsored research.