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DAIDS Deregistration

Guidance regarding the DAIDS deregistration process.

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DAIDS Financial Disclosure Guidance

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

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DAIDS Guidance for Implementing Protocol Changes

Guidance for implementing protocol clarifications or changes.

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DAIDS Investigator of Record (IoR) Form

DAIDS investigator of record form (7/2020).

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DAIDS Letter of Amendment Template

DAIDS letter of Amendment template for a protocol.

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DAIDS Memo Regarding New DAIDS Requirements: Informed Consent Process

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

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

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DAIDS Protocol Change Process Job Aid

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DAIDS Protocol Change Process Policy

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DAIDS Protocol Registration Basic Training

DAIDS protocol registration basic training.

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DAIDS Protocol Registration Policy and Manual Training 2019 - PowerPoint

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DAIDS Protocol Risk Taking Data Capture and Distribution Standard Operating Procedure

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

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DAIDS Protocol Risk Worksheet

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DAIDS Protocol Risk Worksheet Guidelines

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

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DAIDS Protocol Specific Informed Consent Template - General Use

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

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DAIDS Protocol Template for Expedited Adverse Event Reporting

DAIDS expedited adverse event (EAE) reporting template.

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DAIDS Protocol Template Language for Protocol Registration

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

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DAIDS Review of Informed Consent Forms: Impact of the HIPAA Privacy Rule

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

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DAIDS RSC PRO Timelines

DAIDS protocol registration timelines.

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DAIDS Safety Information Types

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

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DAIDS Safety Workshop Durban SA (Nov 2015)

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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DAIDS Safety Workshop Johannesburg SA (Nov 2015)

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 11/5/2012

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

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DAIDS Sample Informed Consent Template - Stored Samples for Future Use

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 Template for Pregnancy Prevention

DAIDS Therapeutic Research Program protocol eligibility criteria for pregnancy prevention.

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