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

Updated: Resources for DAIDS Co-enrollment Prevention Requirements

October 22, 2021

The DAIDS Office of Clinical Site Oversight (OCSO) released a new requirement for co-enrollment prevention SOPs at sites, detailed in a memo dated September 8, 2021. The DAIDS SCORE Manual has been updated to reflect the new co-enrollment prevention requirement, and a webinar was hosted on September 28, 2021 to provide additional context. The webinar recording and slides are available below.

Example co-enrollment prevention SOPs have also been added to the HANC website here.

A summary of the Q&A portion of the webinar is still in development and will be posted on this page once available.

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 March 17, 2021

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