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CRF master inventory list template.

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

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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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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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DAIDS Therapeutic Research Program protocol eligibility criteria for pregnancy prevention.

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Purpose: To define general informed consent procedures. Scope: This procedure applies to all staff involved in obtaining informed consent. (Adapted from the Microbicide Trials Network)

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Purpose: To define informed assent/permission/consent procedures for potential participants who are children. Scope: This procedure applies to all staff involved in obtaining informed assent, parental permission, and consent when children are research participants.  (Adapted from the Microbicide…

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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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DAIDS protocol specific informed consent template—general 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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Protocol Development Lifecycle flowchart

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