NIH/AHRQ Human Participants and Clinical Trials attachments

For questions or additional help with NIH/AHRQ Human Participants and Clinical Trials attachments, contact myRESEARCHnavigators@duke.edu. 

• Human Subjects Study fillable form (download to view); annotated fillable form (see p. 31)

• Study Record: Human Subjects and Clinical Trials Information fillable form (download to view); annotated fillable form (see p. 32-39)

• Availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) Status

• Data and Safety Monitoring Plan

• Delayed Onset Justification

• Dissemination Plan

• Human Specimens and/or Data Not Considered Human Subjects Research

• Inclusion of Individuals across the Lifespan

• Inclusion of Women and Minorities

• Other Requested Information

• Overall Structure of the Study Team

• Protection of Human Subjects

• Recruitment and Retention Plan

• Recruitment and Retention Plan, if using existing dataset/resource

• Single IRB Plan

• Statistical Design and Power  

• Study Timeline