In October 2016, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) hosted the Core Competencies in Clinical Research Workshop, which brought together the JTF, a diverse group of representatives from the clinical research community and stakeholders who have utilized the Framework in their own organizations. Case studies were presented to highlight real-world applications, to gather feedback on potential revisions, and to develop future objectives for the JTF. Following this Workshop, the JTF launched the Revisions Workgroup in order to evaluate changes to the Framework based on suggestions from implementers and stakeholders. The Revisions Workgroup evaluated suggested revisions against a rubric that measured the suggested revision’s impact on stakeholders and implementers, relevance across the clinical research community, global applicability, and necessity.
The revised Core Competency Framework Version 2.0, which resulted from this process, was released on September 1, 2017.
In the process of evaluating revisions, the Revisions Workgroup and JTF decided to make two global changes to the language of the Framework:
- “Clinical trial” to “clinical study,” in order to be more inclusive of different kinds of research
- “Medicines” to “investigational products,” in order to be more inclusive of different interventions (e.g., medicines, devices, combination therapies)
In updating this Core Competency Framework, we recognize the dynamic nature of the clinical research enterprise and endeavor to ensure that the Framework remains relevant to meet the needs of clinicalresearchers globally.