Insights

The ability to move from intentions to actions in support of diversity, equity, and inclusion in clinical research is vital to opening more trials to underrepresented populations, and formulating a diversity action plan according to regulatory guidance is key to the process.

In a forthcoming peer-reviewed article for ACRP’s Clinical Researcher journal, Anthony Chew, a clinical trial operations professional and recent graduate of the MS program in Medical Product Development Management at San Jose State University, describes CRAs as serving as “the primary liaison between the sponsor and the site by monitoring and verifying data to ensure accuracy and adherence to protocols. They collaborate with investigators, conduct site visits [including for site feasibility/selection and validation/qualification purposes followed by study initiation and ongoing monitoring], and maintain strict documentation to guarantee the integrity of a trial.” 

It seems as if there’s an app for everything, and mobile apps are becoming more common in clinical trials. Using an app in a study can be tricky, though, especially when it comes to regulatory compliance.  

The Multi-Regional Clinical Trials Center (MRCT Center) of Brigham and Women’s Hospital and Harvard has introduced the Clinical Research Glossary (CRG), which offers plain language definitions along with additional contextual information that research professionals can use to empower participants and their families.