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DAERS Site User Instructional Guide for EAE Reporting

Formatted specifically for printing. applicable, to special instructions to keep in mind while entering values.

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DAIDS Clinical Trial Application Submission Checklist

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DAIDS Clinicaltrials.gov Protocol Checklist

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DAIDS ClinicalTrials.gov Protocol Checklist, version Date: 20 Nov. 2015

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DAIDS Collaborators Guide

Who are DAIDS collaborators? How are they involved in the protocol development lifecycle? And other information about collaborators.

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DAIDS CRSS ClinicalTrials.gov Initial Registration Process

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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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