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Guidance for implementing protocol clarifications or changes.

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DAIDS letter of Amendment template for a protocol.

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Worksheet designed to assign risk levels to protocols for prioritizing clinical site monitoring resources.

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DAIDS expedited adverse event (EAE) reporting template.

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DAIDS final protocol template language for protocol registration (April 2010).

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Division of AIDS review of imformed consent forms, impact of the HIPAA privacy rule.

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DAIDS sample Informed consent template, stored samples and associated health information for future research use.

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Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.  

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Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.

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