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 & Deadlines
New Issue of the OCSO MOB Newsletter
The 20th 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.
New Resources from DART 1.0
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.
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 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.
Additional updates related to the DAIDS SCORE Manual can be found in the Memos dropdown under OCSO Resources.
Remote Monitoring: Strategies for Site Preparedness and Planning
Medidata RSR FAQ
October 4, 2023. Presenters: Steven Gordon, Bariatu Smith, Grace Roy, Kayode Koleoso, Doreen Campbell, Pia Lohse, Karen Reese.
Remote Source Document Verification (rSDV) FAQs
June 24, 2021.
Remote Monitoring: Visits Logistics for Sites
April 20, 2020. Presenters: Bariatu Smith, Karen Hufham, Manizhe Payton, Bola Adedeji, Karen Reese. Q&A session starts at 28:00.
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.
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
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
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
February 2016December 20, 2021
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 New DAIDS Requirements IC Process
August 21, 2017