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 Electronic Information Systems (EIS) Policy Resources

June 11, 2021

Find resources from the DAIDS Electronic Information Systems (EIS) Trainings here under DAIDS Presentations. Materials include presentation slides from the EIS Policy Training, a recording of the training, and links to additional resources provided by DAIDS.

Changes to CITI Program Access through the DAIDS Learning Portal

May 14, 2021

The HIV/AIDS Clinical Trials Network (ACTG, HVTN, HPTN, IMPAACT, and MTN), DAIDS, and HANC subscriptions to the CITI Program will expire May 31, 2021. After this date, learners will no longer have access to CITI Program courses through their network, DAIDS, or HANC affiliation. These subscriptions will not be renewed beyond May 31, 2021 due to changes in the CITI Program’s pricing structure. This change will not affect access to CITI Program courses through affiliations with other organizations outside of the networks, DAIDS, and HANC, i.e. some universities. Learners who no longer have access to the CITI Program after June 1, 2021 have several options to complete GCP and HSP Training.

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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 EIS Policy Training

DAIDS EIS Policy Training Agenda

DAIDS EIS Policy Training Slides

DAIDS EIS Policy Training Recording from Session B on June 11, 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.

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