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 Updates and Expansion of PPD Remote Review of Pharmacy Source Documents

August 30, 2021

Two new memos are posted under OCSO Resources regarding the recent expansion of remote monitoring for pharmacy source records and revisions to the DAIDS Delegation of Duties Log template. 

August OCSO Monitoring Operations Branch Newsletter

August 19, 2021

The DAIDS Office of Clinical Site Oversight (OCSO) Monitoring Operations Branch (MOB) has released the August 2021 edition of the OCSO MOB Newsletter. Highlights from this issue include a recap of the Critical Events Policy obsoletion, an update on remote source document verification efforts, and year-to-date monitoring metrics. Feedback on the newsletter content and/or suggestions are welcome and can be sent to the Monitoring Operations Branch at ocsomob@niaid.nih.gov.

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 (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.

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