New clinical research agreement service launching May 1 to support WVU researchers

To further support researchers and their clinical research studies, West Virginia University is launching an enhanced service for negotiation for new clinical study agreements, new amendments to clinical study agreements, and clinical data use agreements.

Based at WVU Health Sciences and under the oversight of Associate Vice President for Clinical and Translational Science, Dr. Sally Hodder, the Clinical Study and Data Agreement Office will provide clear and transparent service for clinical study agreement negotiation, including clinical trials agreements and data use agreements.

Beginning May 1, 2024, all negotiation for new clinical study agreements, new amendments to clinical study agreements, and clinical data use agreements will be routed through this new office designed specifically to process clinical agreements in a timely and efficient manner. The process is linked to the Clinical Trials Center of Excellence registration and will be managed in KC+ until the Huron electronic research administration system, WRAP, becomes available in the future.

Any previously existing agreements that were submitted for negotiation prior to April 2024 will remain with their originally assigned negotiator for consistency. Users may notice updates to KC+ as early as April 21 in preparation for the May 1 launch.

A dedicated team of specialists, including a contract agreement specialist and concierge, is ready to provide excellent customer service to clinical investigators and their teams. The team works closely with WVU Medicine, WVU Research Office of Sponsored Programs and WVU General Counsel’s Office to ensure alignment and efficiency.

The research community is also invited to join upcoming virtual information sessions to learn about the new service. RSVP here for either of the sessions listed below:

• April 24, 2024: Noon – 1 p.m. via Zoom
• April 25, 2024: 2 – 3 p.m. via Zoom

Investigators and their team members can email ClinicalStudyAgreements@hsc.wvu.edu for specific questions related to clinical study agreement support and DUA@hsc.wvu.edu for data use agreement support.

General questions about the new service can be directed to Paul Fetty at paul.fetty@hsc.wvu.edu.