Supporting the DAIDS Research Enterprise

Resources from the Division of AIDS (DAIDS) offices, including the Clinical Laboratory Operations Team (DCLOT), Office of Clinical Site Oversight (OCSO), and Office for Policy in Clinical Research Operations (OPCRO).

Announcements & Deadlines

Updated Sample Informed Consent Template

May 23, 2022

A new version of the DAIDS Protocol/Sample Informed Consent Template—General Use template is available on the NIAID website. This template was updated to:

  1. Ensure consistency with the revised Common Rule, related policies, and best practices
  2. Address data-sharing issues, including what type of information may be shared and with whom, and related country-specific consent requirements
  3. Include co-enrollment prevention/age and identity verification process information (see the SCORE Manual)

This template is intended to be used a tool to the Requirements for Informed Consent Forms policy.

Updated Laboratory Policies and Destruction of Specimens SOP

May 19, 2022

The following three policies and SOP are now updated and available on the NIAID website:

  1. Requirements for Laboratories Performing Testing for DAIDS-Supported and/or Sponsored Clinical Trials
  2. Guidance to Investigators Participating in DAIDS-Sponsored Clinical Trials-Requirements for U.S. Laboratories
  3. Guidance to Investigators Participating in DAIDS-Sponsored Clinical Trials-Requirements for Non-U.S. Laboratories
  4. Destruction of Clinical Research Specimens Owned by NIAID/DAIDS SOP

Common External Links

DAIDS Clinical Research Policies and Standard Procedures

DAIDS policies and procedures required for all human subjects research supported and/or sponsored by NIAID.

DAIDS Regulatory Support Center (RSC)

The DAIDS RSC provides support for all regulatory activities using the DAIDS Enterprise System (DAIDS-ES) within the NIAID Clinical Research Management System (NCRMS). 

DAIDS Organization Chart

Organization chart for the Division of AIDS and other divisions within the NIH National Institute of Allergy and Infectious Diseases (NIAID).

DAIDS Presentations

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DAIDS Co-Enrollment Prevention Requirements

DAIDS Co-Enrollment Prevention Requirements Webinar Slides

DAIDS Co-Enrollment Prevention Requirements Webinar Recording from September 28, 2021

Looking for more information? 

  • Examples of site Co-Enrollment Prevention SOPs are posted on the HANC Site Management Resources page under the Site SOP Templates section.
  • Find additional guidance, FAQs, and templates related to the DAIDS Co-Enrollment Prevention Requirements on the DAIDS SCORE Manual website under the Screening, Enrollment/Randomization, and Unblinding of Participants section. 
DAIDS EIS Policy Training

DAIDS EIS Policy Training Agenda

DAIDS EIS Policy Training Slides

DAIDS EIS Policy Training Recording (Session B) from June 11, 2021

DAIDS EIS Policy Training Recording (Session C) from June 29, 2021

Looking for more information? Find the DAIDS EIS Policy and appendices, including the EIS Checklist, implementation memo, and FAQs, on the NIAID website

  • More information about the 21 CRF Part 11 regulation can be found here.
  • EIS checklist submissions and queries related to the EIS checklist should be directed to DAIDSCRSSEISChecklist.sm@ppdi.com
DAIDS SCORE Manual

DAIDS SCORE Manual Launch Webinar
February 9, 2021. Speaker: Gregg Roby.

DAIDS SCORE Manual Launch Slides

Looking for more information? Take a look at the answers to questions asked during the DAIDS SCORE Manual Launch sessions held on February 9, 2021 and February 11, 2021.

Additional updates related to the DAIDS SCORE Manual can be found in the Memos dropdown under OCSO Resources.

Remote Monitoring and Source Document Verification

Remote Source Document Verification (rSDV) FAQs
June 24, 2021.

Remote Monitoring: Visits Logistics for Sites
April 20, 2020. Speakers: Bariatu Smith, Karen Hufham, Manizhe Payton, Bola Adedeji, Karen Reese. Q&A session starts at 28:00.

Remote Monitoring: Visits Logistics for Sites Slides

Looking for more information? Take a look at the answers to questions asked during the DAIDS Remote Monitoring session held on April 20, 2020.

Additional updates related to Remote Monitoring and Source Document Verification can be found in the Memos dropdown under OCSO Resources.

Other

DAIDS Monitoring Processes
October 7, 2019. Presented to the HANC Cross-Network Site Coordinators Working Group. Speakers: Bariatu Smith.

Protocol Deviations Working Group Presentation
June 19, 2019. Presented to the ACTG.

Protocol Signature Page Presentation
February 22, 2017.

DAIDS Clinical Laboratory Operations Team (DCLOT) Resources

Overview of the DAIDS Laboratory Audit Process

As clinical trial sponsor, DAIDS must oversee laboratory operations to ensure (with some level of confidence) that test results generated from all participating laboratories are accurate, reliable and auditable.

GCLP Standards and FAQs

This resource provides answers to the frequently asked questions (FAQs) regarding the DAIDS Guidelines for Good Clinical Laboratory Practice Standards deployment.

Office of Clinical Site Oversight (OCSO) Resources

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Organization Chart

View organization chart
Last modified February 17, 2021

Memos

Minor Updates to DAIDS SCORE Manual: Investigator Responsibilities, Essential Documents, Essential Documents Recordkeeping Appendix, CRS Facility Requirements, Site Activation Process, Source Documentation Requirements Appendix and Record Retention
May 17, 2022

FlowchartMonitoring Update: Expansion of Medidata Remove Source Review (Medidata RSR) to Facilitate Remote Source Document Review
December 20, 2021

Minor Updates to DAIDS SCORE Manual: Documentation of Training and Use of Synchronized Clocks
November 8, 2021

New DAIDS Requirement for Clinical Research Sites: Co-Enrollment Prevention SOP
September 8, 2021

Minor Updates to DAIDS SCORE Manual: DAIDS Delegation of Duties Log Template
August 30, 2021

Expansion of PPD Remote Review of Pharmacy Source Documents for all DAIDS supported or sponsored clinical trials monitored by PPD
August 27, 2021

Minor Updates to DAIDS SCORE Manual: Quality Management, Pharmacy Requirements, Laboratory Requirements
June 28, 2021

Expansion of rSDV to All DAIDS Sponsored Clinical Trials
January 13, 2021

CQMP QA Summary Report Submission Requirements
October 23, 2020

Remote Monitoring Strategy-rSDV
July 23, 2020

Phased Approach to Resumption of On-Site Monitoring Visits
May 11, 2020

Suspension of On-Site Monitoring Visits Extended Through May 15, 2020 and CRS QA Summary Report due June 2020 Eliminated
April 6, 2020

Coronavirus Disease 2019 (COVID-19) Guidance: Suspension of On-Site Monitoring Visits Conducted by PPD at DAIDS Clinical Research Sites
March 19, 2020

New Pharmacy Operations Monitoring Assessment
December 10, 2019

DAIDS CQMP Policy: Submission Requirements
September 12, 2019

Revised Announced Work Order
May 2, 2019

Revised Monitoring Process
January 31, 2019

CQMP QA Summary Report and QM Activities
January 25, 2019

CQMP QA Summary Report and QM Activities
February 15, 2018

CQMP News Blast
February 2016

Survey Reports

DAIDS HIV/AIDS Network Clinical Research Site (CRS) Survey: SARS-CoV-2 Testing
This report is the results of the DAIDS HIV/AIDS Network Clinical Research Site (CRS) Survey: SARS-CoV-2 Testing conducted in April 2020.

Office for Policy in Clinical Research Operations (OPCRO) Resources