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).
Training toolkits from the DAIDS Applied Research Training (DART) pilot event are now available on the HANC website. The DART curriculum includes 13 training modules focused on strengthening Good Clinical Practice (GCP) and International Council for Harmonization (ICH) compliance at clinical research sites. The curriculum emphasizes small group, application-focused learning experiences and is free for sites to use to support staff training.
The 18th edition of the DAIDS Office of Clinical Site Oversight (OCSO) Monitoring Operations Branch (MOB) Newsletter is now published. Find the newsletter under the OCSO Resources section below.
DAIDS Applied Research Training (DART) Training Toolkits
DART Event Site (restricted to 2019 DART Pilot Training attendees, password required)
DAIDS Co-Enrollment Prevention Requirements Webinar Slides
DAIDS Co-Enrollment Prevention Requirements Webinar Recording from September 28, 2021
Looking for more information?
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.
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 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.
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.
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
Flowchart Monitoring 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
MOB Newsletter - December 2021
MOB Newsletter - August 2021
MOB Newsletter - December 2020
MOB Newsletter - July 2020
MOB Newsletter - December 2019
MOB Newsletter - July 2019
MOB Newsletter - December 2018
MOB Newsletter - August 2018
MOB Newsletter - December 2017
MOB Newsletter - July 2017
MOB Newsletter - December 2016
MOB Newsletter - July 2016
MOB Newsletter - April 2016
MOB Newsletter - December 2015
MOB Newsletter - August 2015
MOB Newsletter - April 2015
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.
Tutorial: DAIDS QA Summary Report, New Excel Template
DAIDS developed an updated version of the CRS QA Summary Report Template in a Microsoft Excel format. This tutorial will guide you through the different features included in the excel document.
OPCRO Electronic Information Systems Implementation Memo
August 7, 2020
OHRP Guidance on COVID-19
April 10, 2020
OPCRO Memo Timing of consent and re-consent with updated IRB/EC/RE-approved IC forms
August 20, 2018
OPCRO Memo New DAIDS Requirements IC Process
August 21, 2017