Coordination Areas
Cross-Network

Cross-Network Coordination

Cross-network coordination brings together the expertise, resources, and perspectives of the many groups who contribute towards the operations of the HIV/AIDS clinical trials research enterprise.

Specific areas of cross-network support include leadership, communications, data management & IT, performance evaluations and site management & logistics.

Leadership

HANC facilitates cross-network leadership communication and coordination via monthly calls with the Principal Investigators of the NIH-funded HIV/AIDS Clinical Trials Networks. In addition, HANC holds regularly scheduled calls with the Director of DAIDS and the Directors of OPCRO and OCSO. HANC also participates in NIAID’s Strategic Working Group.

Strategic Working Group (SWG)

The Strategic Working Group (SWG), facilitated by NIAID, provides expert advice on the scientific priorities of the NIH-funded HIV/AIDS Clinical Trials Networks. Specifically, the SWG serves as a forum for discussion, resolution, and proactive planning of critical issues; provides guidance on scientific priorities for future high resource trials, provides input about budget allocation for future funding of the networks and sites, and facilitates communication among all stakeholders relevant to the NIH-funded HIV/AIDS Clinical Trials Networks. The SWG meets one to two times a year, and members include the network principal investigators, NIAID-appointed external advisors, the director of HANC, representatives from the Community Partners, and the Director of DAIDS.

Network Leadership Group (NLG)

HANC organizes focused monthly and ad hoc conference calls with the Network Principal Investigators, the Network Leadership Group (NLG), to address cross-cutting network leadership issues.  The NLG provides a forum for coordination, collaboration and harmonization of cross-network activities. The NLG also provides a venue for DAIDS representatives to discuss proposed revisions or new policies and procedures.

Communications

Communications Working Group (CWG)

The Cross-Network Communications Working Group (CWG) brings together representatives from the HIV/AIDS networks to consider issues influencing HIV/AIDS clinical trials, review communications efforts, consider best practices, and share messaging strategies around major network studies. 

Data Management and IT

The NIH-funded HIV/AIDS Clinical Trials Networks are supported by three Statistical and Data Management Centers (SDMCs):

Data Management Center Working Group (DMCWG)

The Cross-Network DMCWG identifies key areas in which the sharing of expertise, resources, and procedures strengthens capacity and increases efficiency of data management operations. The DMCWG convenes monthly to discuss topics including but not limited to data quality assurance projects, harmonization of data collection processes, coordination of site infrastructure changes, and development of policies impacting clinical trial data management. 

IT Best Practices Working Group (ITBPWG)

The ITBPWG serves as an oversight body responsible for establishing a set of baseline technological standards for sites and laboratories, both domestic and international. This body will convene biennially on even years to revise and update the Information Technology Best Practice Standards at NIH-funded HIV/AIDS Clinical Research Networks’ Study Sites and Site Affiliated Laboratories document to be in accordance with modern guidelines.

Pregnancy Outcomes Data Working Group (PODWG)

The PODWG is a collaboration between SCHARP and Frontier Science to strengthen standards, improve cross-study and cross-network data sharing, and increase alignment in the collection of pregnancy outcomes data across the HIV/AIDS clinical trials networks. The PODWG developed the Cross-Network Pregnancy Data Standards and reviews the document biennially.

Performance Evaluation

Evaluation Working Group (EWG)

The Cross-Network Evaluation Working Group convenes members representing the performance evaluation committees from the HIV/AIDS networks, the Statistical and Data Management Centers, HANC, and DAIDS to discuss opportunities to harmonize evaluation processes and metrics across the networks. 

Site Management and Clinical Trials Logistics

​Site management and clinical trials logistics issues are diverse and addressing each issue involves a varied group of individuals with specific expertise. Network Leadership, DAIDS Leadership, and HANC work closely with the Office of Clinical Site Oversight (OCSO) and Office of Policy in Clinical Research Operations (OPCRO) at DAIDS to identify site concerns and identify appropriate individuals to engage in ad-hoc working groups dedicated towards addressing specified issues. ​

Site Coordinators Working Group (SCWG)

The Cross-Network Site Coordinators Working Group is dedicated towards addressing issues of common concern among clinical research sites (CRS) and harmonizing policies and procedures regarding site-level operations. Group members include representatives from the CRS and clinical trials unit (CTU) level, network operations centers, HANC, and DAIDS. 

Financial Disclosure Working Group

The HANC-facilitated Financial Disclosure Working Group (FDWG) is tasked with reviewing and updating cross-network financial disclosure guidelines. FDWG members provide HANC with a list of investigators to solicit each year. HANC collects financial disclosures from network investigators in leadership roles (i.e. executive committees, scientific leadership committees and protocol leadership positions) on behalf of the networks.

NIH-funded HIV/AIDS Clinical Trials Networks Financial Disclosure and COI Guidelines SOP