DAIDS Regulatory Support Center - Protocol Development Information


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	DAIDS Risk Worksheet Guidelines

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	General Protocol/Amendment Templates
	DAIDS Protocol Template

	DAIDS Letter of Amendment Template (Effective April 12, 2010)

	DAIDS Letter of Amendment Template for updates due to the EAE Manual, Version 2.0, dated January 2010 (Effective May 13, 2010)

	DAIDS Therapeutic Research Program Template for Pregnancy Prevention

	Updated Protocol Registration Section Template
	DAIDS Protocol Template Language for Protocol Registration (Effective April 12, 2010)

	Updated Expedited Adverse Event Reporting Section Template
	DAIDS Protocol Template Wording for EAE Manual Version 2.0

	DAIDS Required Protocol Template Wording for EAE Manual Version 1.0 All protocols requiring expedited reporting of adverse events to DAIDS and submitted for final CSRC/PSRC review after 10 November 2008 must include the Template Wording for the Expedited Adverse Event Reporting Section of DAIDS-Sponsored Protocols, Version 3.0, 11 November 2008.

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