2022

New Animated Video Series: Understanding Science

August 2, 2022

The HANC-facilitated COVID-19 CAB Coalition Work Group formed an ad-hoc work group to develop five scripts to help people better understand science and clinical research. For more information and to view the videos, click here

Job Opportunity: HANC Director

July 27, 2022

The Office of HIV/AIDS Network Coordination (HANC) is recruiting for its next HANC Director. The HANC Director is responsible for managing and supervising all aspects of the activities of HANC, and reports to the principal investigators of the four NIH-funded HIV/AIDS Clinical Trial Networks and the Director of the Division of DAIDS at NIAID. View more details and apply on the Fred Hutch Careers page.

Network Sessions at AIDS 2022

July 25, 2022

Visit the new AIDS 2022 page on the HANC website to see a summary of all sessions, symposia, and satellites affiliated with the HIV/AIDS Clinical Trials Networks at the International AIDS Conference. This page will continue to be updated as more information becomes available. 

Announcing Acting HANC Director

June 27, 2022

Jeffrey Schouten will be retiring from his position as HANC Director on July 1, 2022. There is an ongoing search process for the next HANC Director. In the interim period the Network Leadership Group is pleased to announce that Russell Campbell, HANC Deputy Director, Legacy Project Director, and Community Partners Coordinator, has agreed to serve as the Acting HANC Director until the next HANC Director is hired.

Russell has been with HANC for over fourteen years and HANC Deputy Director for over six years, working closely with Jeff during that time. Jeff has also agreed to serve as a consultant starting August 1, 2022 to assist in the smooth transition during this interim period, and during the onboarding of the next HANC Director. 

New Memo: Minor Updates to DAIDS SCORE Manual Sections

May 17, 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 Page for Sites: Upcoming Deadlines

May 12, 2022

A new page for DAIDS Deadlines has been added to the DAIDS Resources section of the website. On this page, clinical research sites can find reminders for upcoming deadlines related to DAIDS requirements and new initiatives. This page will be updated regularly to reflect new requirements as they are released. 

Updated eConsent Webinar Resources

April 6, 2022

In March 2022, HANC hosted a two-part webinar series exploring the regulatory foundations and implementation of electronic informed consent in clinical trials. The recordings and slides from both webinars are now available on the HANC Webinars & Presentations page.

In addition, an extended Q&A recording has been added for Part 2, eConsent in Practice: Perspectives from Sites. The Q&A addresses questions including how each site verified participant ID, what conditions were needed to implement eConsent, and what support is needed to integrate eConsent more broadly into HIV/AIDS clinical trials. 

Youth Prevention Research Working Group Site Survey Report

March 21, 2022

The Youth Prevention Research Working Group (YPRWG) conducted a site survey in 2021 and recently finalized the site survey report which includes key findings and recommendations. 

YPRWG 2021 Site Survey Report

Network Leaders Express Gratitude

March 9, 2022

Network Leadership would like to share video messages expressing their gratitude and appreciation to the NIH HIV/AIDS Clinial Trials Network research staff and community. Click below to view the video messages.

Watch Video Messages

Network Presentations at CROI 2022

February 7, 2022

The Conference on Retroviruses and Opportunistic Infections (CROI) begins on February 12, 2022. Taking place as a fully virtual conference this year, the conference program features discoveries in HIV, hepatitis viruses, SARS-CoV-2, and other viral infections and their related conditions.

Each of the HIV/AIDS Clinical Trials Networks will be presenting at the conference. Find the compiled list of network sessions here.

Building Indigenuity, Generating HIV Science: HIV/AIDS Research Training (BIG HART)

February 4, 2022

The UW/Fred Hutch Center for AIDS Research (CFAR) will be working in collaboration with scholars at University of Washington’s (UW) Indigenous Wellness Research Institute (IWRI) and the University of Hawaii (UH) to launch a new project titled “Building Indigenuity, Generating HIV Science: HIV/AIDS Research Training (BIG HART)” This exciting new training opportunity will be led by Jen Balkus, PhD, MPH, CFAR DEI Lead and Assistant Professor in the Department of Epidemiology in the School of Public Health, and Karina Walters, MSW, PhD (Choctaw Nation of Oklahoma), Co-Director of IWRI, Professor and Associate Dean in the School of Social Work.

New Resource: IT Security Best Practices

January 12, 2022

A new version of the IT Security Best Practices (v5.0) is now published under Data Management & IT Resources. The IT Security Best Practices document outlines a recommended approach for NIH HIV/AIDS Clinical Trials Network research sites and labs to manage information technology and cybersecurity risks. This document was developed by the HANC-facilitated IT Best Practices Working Group (ITBPWG), whose members include the DAIDS, SCHARP, Frontier Science, NIH Office of Cyber Infrastructure and Computational Biology (OCICB), and HANC.

 

2021

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.

The Legacy Project Launches the “H=H, the H is for Human" Podcast

November 1, 2021

Join an informal conversation with the Legacy Project team and its working group members in the inaugural launch of the podcast, "H=H, the H is for Human". H=H is a podcast that centers on the human side of HIV research education, affirming Black, Indigenous, and other People of Color (BIPOC), and sexual gender minority communities disproportionately impacted by HIV. 

We invite you to listen to this first episode, subscribe, and share it with your friends, family, and colleagues. Send us your comments and let us know what topics you would like H=H to cover in upcoming episodes!

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 under DAIDS Presentations section.

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 the DAIDS Resources page once available.

The Legacy Project will support the Black AIDS Institute’s training program for students from HBCUs

October 21, 2021

The Black AIDS Institute (BAI), the nation’s only ‘think and do tank’ focused on ending HIV in all Black communities, was the sole recipient of the Health Resources & Services Administration - HIV/AIDS Bureau’s (HRSA/HAB) eight million dollar grant for a biomedical justice initiative. This four-year project led by BAI, in partnership with Cardea and the Legacy Project, aims to develop a national training program for students from Historically Black Colleges and Universities (HBCUs) to expand and diversify a strong pipeline of HIV advocates and leaders equipped to end the HIV epidemic.

DAIDS SCORE Manual Updates and Expansion of PPD Remote Review of Pharmacy Source Documents

August 30, 2021

Two new memos are posted under DAIDS 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.

RFA Announcement: Small Clinical Trials Advancing HIV Remission and Cure

July 23, 2021

The AIDS Clinical Trials Group (ACTG) Network is requesting applications for small experimental trials (<30 participants) to advance HIV remission and cure efforts. This opportunity is open to investigators with interest in experiemntal science clinical trials addressing questions important to the HIV cure agenda, and proposing investigators do not need to be affiliated with the ACTG. For more information, see the RFA - Small Clinical Trials Advancing HIV Remission and Cure

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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Thank you to the HIV/AIDS research community

April 2, 2021

We want to share a message of gratitude to research staff and community as we begin the new funding cycle for the HIV/AIDS clinical trials networks from Dr. Carl Dieffenbach, Director, Division of AIDS, NIAID.

Watch Full Video

HANC unveils newly refreshed website in collaboration with Fred Hutch

March 25, 2021

Welcome! The HANC team is excited to launch the newly redesigned Office of HIV/AIDS Network Coordination (HANC) website. Located at the same address, hanc.info, the new HANC website is crafted to be easier to navigate, mobile-friendly, and modernized in design.

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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.

2020

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​​.