Recommendations for sponsors, CROs, and health systems/private practices
I. Recommendations for developing site-based research infrastructure & staff
- Recognize principal investigators, co-investigators, and research coordinators as key contributors to product development
- Provide opportunities for investigators and site staff to remain engaged in between trials
II. Recommendations for optimizing trial execution and conduct
- Create enrollable study protocols and ensure effective recruitment planning
- Follow FDA safety reporting requirements
III. Recommendations for site budget and contract negotiations
- Use master agreements whenever possible
- Foster transparency about fair market value (FMV) determination
IV. Recommendations for investigators interested in conducting additional studies
N/A
Recommendations for identifying and developing new investigators. Medical schools, industry sponsors, clinical research organization (CROs) and physicians themselves should use active measures to identify, initiate, and train site investigators.
Source: Clinical Trials Transformation Initiative. CTTI recommendations for strengthening the investigator site community. Published October 2017. https://www.ctti-clinicaltrials.org/projects/investigator-community
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