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Resources

External & Regulatory Resources

DAIDS Regulatory Compliance Center (RSC)

Regulatory resources, including AE reporting manuals and forms, protocol registration materials, and toxicity tables, are available on the RSC website. There you will find the most current version of these resources, often with multiple format options. Some materials may be password protected.

Instructional videos have been posted to the RSC Website

  • How to Access Your Clinical Research Site (CRS) Profile Report through the DAIDS Protocol Registration System (DPRS) - view video

  • How to Modify Personnel at Your Site Using the DAIDS Adverse Experience Reporting System (DAERS) - view video

DAIDS SOPs

Financial Disclosure and Conflict of Interest Guidelines Standard Operating Procedure

ClinRegs

  • The ClinRegs website is designed to help the research community explore clinical research regulations within specific countries and compare regulatory requirements across countries.

FDA Financial Disclosure by Clinical Investigators

New Study-Specific FDA Financial Disclosure Form Issued
This form is based on the FDA Financial Disclosure by Clinical Investigators. All individuals listed on an FDA Form 1572 for an IMPAACT study conducted under an Investigational New Drug (IND) application with the US FDA must have on file at the site a completed financial disclosure form prior to enrollment of any participants in that study. Each CTS will follow-up with the study teams to complete these forms and to provide further instructions. View Sample Form

Other Regulatory Resources

Human Subject Protection Resources

Clinical Resources

NIAID and DAIDS Policies and Guidance Documents

 

 

 

 

 

 

 

 

 

 

 

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.