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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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!
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 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.
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.
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 email@example.com.
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.
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.
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.
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.
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.
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.
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.
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.
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.firstname.lastname@example.org.