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Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents

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DAIDS Protocol Registration Frequently Asked Questions

This section provides answers to the frequently asked questions (FAQs) regarding DAIDS requirements for Protocol Registration Policy:

I. GENERAL

 
 
 
 
 

II. FORM FDA 1572/DAIDS INVESTIGATOR OF RECORD (IOR) FORM

 
 
 
 
 
 
 

III. CURRICULUM VITAE (CV)

 

IV. PROTOCOL REGISTRATION SUBMISSIONS (AMENDMENTS, LETTER OF AMENDMENT (LoAs), SUB-STUDIES)

 
 
 
 
 
 
 

V. SITE-SPECIFIC INFORMED CONSENT FORM (ICF)

 
 
 
 

VI. INSTITUTIONAL REVIEW BOARD/ETHICS COMMITTEE (IRB/EC), INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)& OTHER REGULATORY ENTITY (RE)/APPROVING ENTITYAPPROVALS

 
 
 

VII. TRANSLATION REQUIREMENTS

 
 
 
 
 

VIII. DEREGISTRATION

 
 
 

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Last Updated May 19, 2010

Last Reviewed May 19, 2010