Protocol Templates
The PPHS recommends using the NIH template if you are creating your own protocol involving human subjects. The PPHS requires a protocol with most projects coupled with one of the three HRP 503 templates. An example of an NIH template can be found here. Researchers can use their grant application, industry protocol or another version of a protocol providing it has all the necessary elements.
Consent Templates
The Program for the Protection of Human Subjects (PPHS) provides consent templates.
Tools
The NIH web-based clinical trials E-Protocol Writing Tool assists in the collaborative development of protocols for Phase 2 and 3 IND/IDE as well as behavioral and social sciences clinical trials. The e-protocol writing tool uses the NIH-FDA Phase 2 and 3 IND/IDE protocol template as well as the NIH Behavioral and Social Sciences protocol template.
Resources
- CTTI Learn About Quality by Design (QBD)
- CTTI Quality by Design (QBD) – Critical to Quality (CTQ) Factors Principles Document
- FDA – Drug Study Design
- FDA – Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics
- Levy Library Research Support
- NCI – CTEP Protocol Development Template and Guidelines
- SPIRIT Statement – Standard Protocol Items: Recommendations for Interventional Trials
- CLIC – Study Design Resources
Research 411 Portal
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