New Resources from DART 1.0

September 28, 2022

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. 

New Issue of the OCSO MOB Newsletter

August 19, 2022

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. 

Updated Glossary of DAIDS Clinical Research Policy Terms

August 9, 2022

The Office for Policy in Clinical Research Operations (OPCRO), DAIDS is pleased to announce that the Glossary of Division of AIDS Clinical Research Policy Terms has been updated. The glossary can be found on the NIAID website.

Clarification of single IRB requirements

July 13, 2022

A new resource, "Information Sheet: Single Institutional Review Board (sIRB) Requirements," is now available on the NIAID website. This document includes information on when the sIRB requirement applies and several scenarios to illustrate the requirement. 

GCLP Training Frequently Asked Questions

June 8, 2022

A new DAIDS Good Clinical Laboratory Practice Training Related FAQs is now available for all DAIDS-sponsored clinical research laboratories. Find the FAQs on the NIAID website.

Updated Sample Informed Consent Template

May 23, 2022

A new version of the DAIDS Protocol/Sample Informed Consent Template—General Use template is available on the NIAID website. This template was updated to:

  1. Ensure consistency with the revised Common Rule, related policies, and best practices
  2. Address data-sharing issues, including what type of information may be shared and with whom, and related country-specific consent requirements
  3. Include co-enrollment prevention/age and identity verification process information (see the SCORE Manual)

This template is intended to be used a tool to the Requirements for Informed Consent Forms policy.

Updated Laboratory Policies and Destruction of Specimens SOP

May 19, 2022

The following three policies and SOP are now updated and available on the NIAID website:

  1. Requirements for Laboratories Performing Testing for DAIDS-Supported and/or Sponsored Clinical Trials
  2. Guidance to Investigators Participating in DAIDS-Sponsored Clinical Trials-Requirements for U.S. Laboratories
  3. Guidance to Investigators Participating in DAIDS-Sponsored Clinical Trials-Requirements for Non-U.S. Laboratories
  4. Destruction of Clinical Research Specimens Owned by NIAID/DAIDS SOP

New Memo: Minor Updates to DAIDS SCORE Manual Sections

May 18, 2022

A new memo from the DAIDS Office of Clinical Site Oversight (OCSO) notes minor updates to the Site Clinical Operations and Research Essentials (SCORE) Manual. These updates affect the following sections: Investigator Responsibilities, Essential Documents, Essential Documents Recordkeeping Appendix, CRS Facility Requirements, Site Activation Process, Source Documentation Requirements Appendix, and Record Retention.


New DAIDS Memo and Edition of the MOB Newsletter

December 20, 2021

A new memo from the DAIDS Office of Clinical Site Oversight (OCSO) provides information on the status, plans, and expectations for remote monitoring of studies configured in Medidata Remote Source Review (RSR) and guidance on use of this platform for all DAIDS sponsored studies.

The December 2021 edition of the Monitoring Operations Branch (MOB) newsletter also discusses the expansion of Medidata RSR as well as tips for navigating remote regulatory assessments.

Both resources are posted under the DAIDS Resources section.

Memo: Minor Updates to DAIDS SCORE Manual

November 8, 2021

Minor revisions were made to the DAIDS SCORE Manual requirements for the documentation of training. In addition, a clarification on synchronization of clocks has been added to the SCORE Manual FAQ. See the memo dated November 8, 2021 for full details of the changes.

Updated: Resources for DAIDS Co-enrollment Prevention Requirements

October 22, 2021

The DAIDS Office of Clinical Site Oversight (OCSO) released a new requirement for co-enrollment prevention SOPs at sites, detailed in a memo dated September 8, 2021. The DAIDS SCORE Manual has been updated to reflect the new co-enrollment prevention requirement, and a webinar was hosted on September 28, 2021 to provide additional context. The webinar recording and slides are available on the DAIDS Resources page.

Example co-enrollment prevention SOPs have also been added to the Site Management Resources page.

A summary of the Q&A portion of the webinar is still in development and will be posted on this page once available.

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.

DAIDS Electronic Information Systems (EIS) Policy Resources

June 30, 2021

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

Updated DAIDS Electronic Information Systems (EIS) Policy and EIS Evaluation Checklist

June 25, 2021

The Office for Policy in Clinical Research Operations (OPCRO), DAIDS is pleased to announce the availability of the updated policy, "Electronic Information System (EIS) Policy” and associated, “Electronic Information System Evaluation Checklist”.  This policy has been updated to clarify the scope, and clarify validation responsibilities for non-COTS systems. The associated checklist has been updated with minor changes. The checklist and associated Policy, additional Appendices, and Frequently Asked Questions (FAQs) can be found on the NIAID website.

If you have any questions regarding this associated policy or the associated checklist, please email DAIDSProPEP@mail.nih.gov.

New Remote Source Document Verification FAQs

June 25, 2021

A new frequently asked questions (FAQs) document is now available to address various aspects of Remote Source Document Verification (rSDV). Find the FAQs under the Remote Monitoring and Source Document Verification section.

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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DAIDS SCORE Manual Now Available

January 26, 2021

The DAIDS is excited to launch the Site Clinical Operations and Research Essentials (SCORE) Manual. The SCORE Manual is a new site-facing resource which consolidates DAIDS operational and procedural requirements to support the implementation of DAIDS-sponsored clinical research within the DAIDS Clinical Trials Networks. The manual serves as a reference describing DAIDS requirements and may be used as a resource for current site staff as well as for on-boarding new research personnel.

 The DAIDS Learning Portal is also updated with new and revised trainings to improve adherence to and understanding of DAIDS policies and procedures, and current ICH GCP guidelines.


New DAIDS Electronic Information Systems Policy

August 21, 2020

The Office for Policy in Clinical Research Operations (OPCRO), DAIDS is pleased to announce the availability of the new Electronic Information Systems Policy. This new policy has been developed to ensure consistency of Electronic Information Systems with 21 CFR part 11 and regulatory guidance. The Policy, associated Appendices, Frequently Asked Questions (FAQs) and the Implementation Memo can be found on the NIH website​ and is also posted in our DAIDS resources page.

Please note that DAIDS plans for a phased implementation of this policy, as described in the Implementation Memo​. If you have questions regarding this policy, please review the FAQs​. If your query is not addressed in the FAQs, email DAIDSCRSSEISChecklist.sm@ppdi.com​​.

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