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Instructions Page for the DAIDS Sample Informed Consent Template - Stored samples and Associated Health Information for future Research Use

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

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LOA Flowchart

Letter of amendment flowchart for Protocol Teams.

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Non-IND Protocol Lists

Completed Non-IND studies that have met or exceeded the 3 year retention period (per 45 CFR 46.115); CRFs and pharmacy records will not be stored by DAIDS.

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Protocol Development Lifecycle Resource

Protocol Development Lifecycle flowchart

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Protocol Registration at a Glance Quick Reference Card

Quick reference card for protocol registration at a glance.

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Protocol Registration Checklist

Division of AIDS (DAIDS) protocol registration checklist. NOTE: This form is not required if submitting materials through the DAIDS Protocol Registration System (DPRS).

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Protocol Registration Checklist (Alternate Format)

Division of AIDS (DAIDS) protocol registration checklist. NOTE: This form is not required if submitting materials through the DAIDS Protocol Registration System (DPRS).

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Required Documentation Based on 45 CFR 46

Required documentation of risk/benefit category and approval of clinical studies for inclusion of children by institutional review boards/ethics committees based on 45 CFR 46, Subpart D.

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Study Statuses

Study statuses and milestones handout.

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Translation Confirmation Document

DAIDS protocol registration translation confirmation document.

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Uganda - Expedited Reporting to DAIDS and DAERS Refresher June 2014

Zip file contains: Presentation slides from ACTG June 2014 network meeting Presentation to ACTG about expedited reporting on Adverse Events Presentation to ACTG about reporting via DAERS Case study on Adverse Events Case Study on chest pain

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