The UNC Global Infectious Diseases Clinical Trials Group (Chapel Hill CRS) is hiring a Project Manager (CRS Coordinator). They are looking for an experienced manager to oversee the staff and unit administration. The position is posted here: https://unc.peopleadmin.com/postings/220373 and will be accepting application through 2/4/22.
Questions about the position should be directed to:
Susan Pedersen: firstname.lastname@example.org
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.
The University of California, San Francisco, Center for AIDS Prevention Studies (CAPS) announces the Ujima Mentoring Program (Ujima Program). Funded by the National Institutes of Mental Health (NIMH) AIDS Research Centers (ARC) Program, the Ujima Program provides multidisciplinary research mentoring and funding to early-stage investigators, particularly those at Historically Black Colleges and Universities (HBCUs), who focus their programs of research on high priority areas that address HIV prevention, care, and treatment in Black/African American communities. Applications are due by February 11th, 2022 at 11.59 pm Pacific Standard Time.
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.
The development of a safe and effective HIV vaccine is one of the greatest biomedical research challenges of our time. The HIV Vaccine Trials Network (HVTN) is now accepting applications for Research and Mentorship Program (RAMP) Scholar Awards to attract African American/Black and Latinx medical students who want to make a difference in their communities and contribute to the development of an effective HIV vaccine. Applications are due on January 3, 2022.
The HIV Prevention Trials Network (HPTN) is proud to offer two scholarship programs for early-career investigators funded through a supplement from the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH). The HPTN Scholars Program now includes two components: a domestic (U.S.) program and an international program. Both programs seek to increase opportunities for scientists from groups under-represented in HIV prevention research. In the domestic program, successful applicants will be investigators who have received their terminal degree (MD, PhD, etc.). Initial drafts proposal due at 5pm ET- Friday, December 10, 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!
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.