The clinical research professionals of the Clinical Research Operations Core provide exceptional support and service to investigators conducting clinical research studies at Boston Children’s Hospital. The core supports a full spectrum of studies from high-risk interventional trials with experimental therapeutics, and experimental drugs and devices, to the minimal-risk observational clinical research studies. The core provides exceptional service in the following areas:
- protocol development
- project management for planning and implementation of studies
- case report form creation
- coordination of database builds
- recruitment and retention of research subjects
- administration of surveys, interviews and study tracking
- biospecimen collection and tracking
- medical record abstraction, data entry and reports
- study close out activities management of multi-institutional clinical trials
- single patient INDs
- support for FDA-regulated trials
- development of data safety monitoring plans and data safety monitoring boards or committees
- facilitating collaborative partnerships among key institutional resources that support clinical research
- foster collaborative relationships between clinical trialists and basic/translational researchers
- support for grant applications and publication submissions
- medical writing
- scientific review
- support for consortium work
For more information or to request assistance, contact Leah Cheng.
