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
Clinical Research Record Retention Requirements
DAIDS recently worked with DAIDS RSC to update their webpage related to Record Storage. The link with the updated RSC website information can be found here: https://rsc.niaid.nih.gov/clinical-research-sites/daids-record-storage-assessment
Please see the attached memo from the DAIDS Regulatory Affairs Branch for more information.
Electronic Information Systems Policy Update
An update to the Electronic Information Systems (EIS) Policy was issued by DAIDS QA. Please see the memo for more information.
Clarification to the DAIDS AE Grading Table
The DAIDS Office for Policy in Clinical Research Operations (OPCRO) has made revisions to the DAIDS AE Grading Table.
Please see the memo and the updated grading table for more information.
DAIDS Co-Enrollment Prevention Requirements Webinar Slides
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 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 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: Strategies for Site Preparedness and Planning
Presentation Slides
Medidata RSR FAQ
Presentation Q&A
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.
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.
DAIDS SCORE Manual Releases - Impact to Sites
June 20, 2025
Updates to DAIDS SCORE Manual: Appendix Source Documentation Requirements, Informed Consent of Participants, Site Visits
Summary of Changes
June 4, 2024
Minor Updates to DAIDS SCORE Manual
Summary of Changes
September 28, 2023
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
February 2016December 20, 2021
2024
MOB Newsletter - December 2024
MOB Newsletter - July 2024
2023
MOB Newsletter - December 2023
MOB Newsletter - August 2023
2022
2021
MOB Newsletter - December 2021
MOB Newsletter - August 2021
2020
MOB Newsletter - December 2020
MOB Newsletter - July 2020
2019
MOB Newsletter - December 2019
MOB Newsletter - July 2019
2018
MOB Newsletter - December 2018
MOB Newsletter - August 2018
2017
MOB Newsletter - December 2017
MOB Newsletter - July 2017
2016
MOB Newsletter - December 2016
MOB Newsletter - July 2016
MOB Newsletter - April 2016
2015
MOB Newsletter - December 2015
MOB Newsletter - August 2015
MOB Newsletter - April 2015
2014
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.
Clinical Research Record Retention Requirements
May 21, 2025
Clarification to the DAIDS AE Grading Table
February 28, 2025
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
Cross-Network Protocol Deviation Reporting Guide
September 29, 2023