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Process for collection of financial disclosure by clinical investigators conducting DAIDS-sponsored IND trials.

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Guidance for implementing protocol clarifications or changes.

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DAIDS investigator of record form (7/2020).

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DAIDS letter of Amendment template for a protocol.

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DAIDS Memo Regarding Timing of Consent and Re-Consent with Updated IRB/EC/RE-Approved Informed Consent Forms.

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DAIDS protocol registration basic training.

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DAIDS protocol risk ranking data capture and distribution standard operating procedure, worksheet and flow chart.

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

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

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DAIDS protocol registration timelines.

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Definitions of the types of safety information distributed by DAIDS and methods of distribution.

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Training workshop in Durban, SA supporting documents: Case Review: All About AEs - Safety Training Expedited Reporting and Assessment - Safety Training Expedited Reporting via DAERS - Safety Training Expedited reporting via DAERS - Case Study

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Training workshop in Johannesburg, SA supporting documents: Case Review: All About AEs - Safety Training Expedited Reporting and Assessment - Safety Training Expedited Reporting via DAERS - Safety Training Expedited reporting via DAERS - Case Study

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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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