Demonstration Projects Required Materials and Resources
- Application Guide for Demonstration Projects
- Best Practices for Integrating Health Equity Concerns into Embedded Pragmatic Clinical Trials for Dementia
- IMPACT DSMB Charter
- IMPACT Resource and Data Sharing Plan
- IMPACT Waiver Guide
- Template - Acknowledgment Letter from IRB/HRPP Official
- Template - Clinical Trial Milestone Plan
- Template - Data and Safety Monitoring Plan
- Template - Dissemination Plan
- Template - Demonstration Project Pragmatic Design Worksheet
- Template - Single IRB
- Template - Study Record: PHS Human Subjects and Clinical Trials Information Form (Forms G version)*
* NIH Form cannot be opened in a web browser, requires opening in a desktop application. Requires Adobe Reader 8 or higher to open.
Relevant Resources