CRO facilitated Trans-NIH committee to develop protocol template with NIDCR

Research Triangle Park, NC – June 25, 2019 – Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, announced today that Rho’s Principal Research Scientist and Program Lead Nancy Yovetich, PhD, and Project Manager Lisa Busko  participated in a trans-NIH + extramural committee to develop a standardized protocol template for behavioral and social science researchers.  Yovetich and Busko, facilitated committee meetings, template development, and document updates based on the formal public comment phase.

This new resource helps behavioral and social science researchers prepare research protocols for human studies measuring a behavioral or social outcome or testing a behavioral or social science-based intervention. The template has been fully integrated into the NIH’s Clinical e-Protocol Writing Tool.

The Behavioral and Social Science Clinical Trials Template was derived from the successful NIH-FDA Phase 2/3 IND-IDE Clinical Trial Template, and was adapted to include terminology and approaches used by behavioral and social scientists. The NIH Office of Science Policy shares some of the reasons investigators may want to adopt this template on her blog:

The template is an effective resource for communicating the science, methods, and operations of a clinical trial, thus allowing for standardization of procedures and guiding replication studies.
Consistent use of the template will reduce the chance for inaccuracies in study procedures that could potentially result in null or spurious findings.
It fosters training and accountability of study staff and allows for efficient review by peers and oversight bodies.
It assists investigators who are less familiar with the information and level of detail expected in a clinical protocol and fully adheres to the International Conference on Harmonisation E6 Good Clinical Practice guidelines.
Utilizing the template through the e-Protocol Writing Tool allows users to seamlessly send and edit protocol information directly to ClinicalTrials.gov.

While the template is a suggested format for clinical trials that are testing a behavioral or social intervention or manipulation for which a stand-alone clinical protocol is required, the template can also be a useful tool for those trials funded by NIH institutes or centers that do not require stand-alone clinical protocols. Using the template to anticipate decision points and potential challenges before a study launches can help avoid delays down the road.

Rho’s support for this project was funded in full with Federal funds from the National Institute of Dental and Craniofacial Research (administered by the National Heart, Lung, and Blood Institute), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN268201400073C.

To learn more about Rho, please visit www.rhoworld.com.

About Rho

Rho, a privately-held, contract research organization (CRO) located in Research Triangle Park, NC, provides a full range of clinical research services across the entire drug development process. For more than 35 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Facebook, LinkedIn and Twitter.