David R. Bobbitt, president and CEO at Clinical Data Interchange Standards Consortium (CDISC), appointed Shannon Labout CDISC’s interim chief standards officer. A collaborative leader, dedicated educator and Certified Clinical Data Manager (CCDM), Labout has a proven track record of creating, leading and growing successful organizations in clinical data management, standards implementation and training. In her new role, she will guide the future of standards development, working with CDISC leadership, partners, members and volunteer teams. She will also continue to serve as CDISC’s VP of Education.

“I am excited that Shannon is taking this key role,” Bobbitt commented. “Now that CDISC standards are required by the FDA and PMDA, endorsed by China FDA, and requested for use by the European Innovative Medicines Initiative (IMI), CDISC is at a critical inflection point. Shannon’s leadership will ensure we do what is necessary to support our volunteer teams while building sustainable clinical data standards.”

“Shannon has a great ability to motivate her team and leverage each individual's strengths, which is difficult enough with a dedicated pool of resources, so it is even more impressive that she is able to accomplish this with a team primarily consisting of volunteers,” said Lauren Shinaberry, associate director, Data Standards, AbbVie and CDISC Volunteer.

“As an implementer of CDISC standards since 1999, a volunteer and instructor for eleven years, and member of CDISC staff and leadership for over seven years, I am deeply aware of the challenges and opportunities facing CDISC and our community,” added Labout. “It is a great privilege to be able to influence the future of the CDISC organization in this new role.”

CDISC began as a grass roots initiative in 1997 in response to the need to better structure and improve the quality and consistency of data in clinical research. Volunteers came together to create workgroups and share the idea of CDISC, building awareness and generating support. Ms. Labout has served as a CDISC staff member since 2010 and a volunteer since 2006.