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

DAIDS SCORE Manual Now Available

January 26, 2021

The DAIDS is excited to launch the Site Clinical Operations and Research Essentials (SCORE) Manual. The SCORE Manual is a new site-facing resource which consolidates DAIDS operational and procedural requirements to support the implementation of DAIDS-sponsored clinical research within the DAIDS Clinical Trials Networks. The manual serves as a reference describing DAIDS requirements and may be used as a resource for current site staff as well as for on-boarding new research personnel.

 The DAIDS Learning Portal is also updated with new and revised trainings to improve adherence to and understanding of DAIDS policies and procedures, and current ICH GCP guidelines.

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 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.

Remote Monitoring

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.

CQMP

Requirements for Clinical Quality Management Plans (CQMP) Policy
October 17, 2019. Speakers: Bariatu Smith, MJ Humphries, and Isabel Guerra. Q&A session starts at 33:00.

Requirements for Clinical Quality Management Plans (CQMP) Policy Slides

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

Guidelines and Documents

QA Summary Report Preparation Guidelines

Guidelines for Clinical Research Site (CRS) staff on Preparation of the Bi-annual Quality Assurance (QA) Summary Report required per DAIDS Clinical Quality Management Plan (CQMP) Policy. Version 1.0, October 22, 2019

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