PHIRST: Supporting Documents

 The system will prompt you to upload all applicable study documents:

• The funding agreement

• If NIH funded, the Data Management and Sharing Plan

• BSPH training certifications for study team members

• The Research Plan for your study

• All documents to be used with study subjects (including Recruitment Materials and Consent Forms, surveys, guides, etc.)

• Translated consent forms and recruitment documents (once the BSPH PHIRST application has been approved) with a Certificate of Translation

• Study product information (for food supplements, drugs, devices, etc.)

• Local IRB approvals, permissions, letters of collaboration, etc.

•  All consents and recruitment materials must be uploaded in a Word format.

• All documents should include study identifiers which include PI name, study title, IRB number, date, and version number.

•  Contact the PHIRST Help Desk for technical assistance at JHSPH.PHIRSTHelp@jhu.edu

•  Need help with a research application? Which forms do you need? Which Research Plan? The IRB Navigator may be able to help: IRBNav@jh.edu.

•  What do I need to submit?

• Recruitment Materials Guidance

• Guidance on Document Control and Naming Conventions