Annual Progress Report on Supplement: Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ)

Specific Aims:

The goal of the supplement is to create a standardized, comprehensive training and qualification system for Good Clinical Practice (GCP) in conducting clinical trials across all CTSA sites.

The specific aims are:

  1. Streamline and standardize training in GCP across the CTSA consortium

  2. Develop a training platform that equips a highly qualified workforce with the necessary competencies to more effectively, efficiently, and safely execute clinical trials.  

Accomplishments:

Sixty-two CTSAs have participated in the development of the GCP training. Two working meetings of representatives from these CTSAs were conducted: the first in November 2014 and the second in February 2015.  Carolyn Apperson-Hansen and Jim Spilsbury are the CTSC’s representatives for this initiative and have participated in all initiative functions.  To date, accomplishments include:

  1. Developed a set of recommendations for GCP training and re-certification in GCP for NCATS;

  2. Developed competencies for and identified training resources/gaps in the following GCP domains:  Scientific Concepts & Research Design; Ethical & Participant Safety Considerations; Investigational Products Development & Regulation; Clinical Trials Operations (GCPs); Study & Site Management; Data Management & Informatics; Leadership & Professionalism; Communication; Teamwork & Team Science;

  3. Tailored competencies to needs of socio-behavioral investigators conducting intervention research that meets the NIH definition of a clinical trial;

  4. Examined potential training platforms to be used;

  5. Identified potential metrics to track GCP training;

  6. Initiated processes to develop agreements and partnerships with companies, centers, and organizations to assist in actual production and promulgation of training modules.

As part of their contribution to this supplement, Apperson-Hansen and Spilsbury participated as members of working groups who met numerous times via conference call to address competencies and training plans for specific GCP domains:  

  • GCP metrics (Apperson-Hansen),

  • Data management and informatics (Apperson-Hansen, Co-Lead),

  • Communication and teamwork (Spilsbury),

  • GCP in socio-behavioral research (Spilsbury).

On the local level, Spilsbury and Apperson-Hansen are member of the CTSC Clinical Team Training Taskforce (chaired by Spilsbury), which consists of representatives from each of the CTSC partner institutions and research centers (i.e., Comprehensive Cancer Center) who develop and implement training activities for investigators and research staff in the areas of RCR, GCP, and human-subjects research.  Spilsbury and Apperson-Hansen have kept the Taskforce abreast of supplement activities so that the CTSC partner institutions are poised to integrate ECRPTQ products as they become available.

Moreover, the set of competencies developed by the ECRPTQ have been shared with the city-wide group by Phil Cola, director of the CTSC Regulatory Knowledge Support Core, to insure that upper-level leaders across the CTSC partners are aware of ECRPTQ activities and can support them.  

Status of Milestones:

  • Phase 1: Recommendations developed for training and re-training on Good Clinical Practice for the clinical trial workforce.  

  • Phase 2: GCP Competencies and associated training resources and needs developed, compiled, and shared with the Joint Task Force on Clinical Trial Competency, CTSA Steering Committee, CTSA principal investigators’ meeting, and with other key stakeholders.  

Next Steps:

  1. Meeting of the ECRPTQ Leadership, Domain-Working Group Co-Leaders and other key stakeholders Sept 2015 to finalize and harmonize competencies with the Joint Task Force (JTF) for Clinical Trial Competency.

  2. Spilsbury will continue to participate with the Socio-Behavioral Working Group to further develop training activities for GCP Clinical Trials as it relates to socio-behavioral research.

  3. Integration of competency-based training across CTSAs.

Update from September 11, 2015 Meeting in Ann Arbor, Michigan

  • Goal  

    • Work towards a single competency framework for the clinical research enterprise

    • Incorporate views of key stakeholder groups

  • Identified and agreed upon the potential areas of overlap between the GCP domains:  Scientific Concepts & Research Design; Ethical & Participant Safety Considerations; Investigational Products Development & Regulation; Clinical Trials Operations (GCPs); Study & Site Management; Data Management & Informatics; Leadership & Professionalism; Communication; Teamwork & Team Science

  • For each competency of the GCP domains outlined previously, reviewed suggested wording from the JTF, Dallas Meeting/April 1, and Utah Meeting/April 27 and revised as needed to harmonize the wording from the three groups

  • Phase II deliverables will be updated with work from this meeting.

  • Writing team will add assessments to revised competencies and distribute to the co-leads by 9/21 and request comments/feedback from the Co-leads and project leadership by 9/30

  • CTSA PIs will receive revised deliverables by 10/7, request comments/feedback from the Steering Committee by 10/22, and the writing team will incorporate findings by 11/6

  • NCATS Steering Committee will received revised deliverables on 11/6, request comments/feedback from the NCATS Steering Committee by 11/26, and the writing team will incorporate findings by 12/10

  • Meeting Summary abstract supplied by MICHR:

    • MICHR hosted the third meeting of the NCATS supplement project "Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ)" on Friday, September 11 in Ann Arbor, MI. 

      This project aims to improve the safety, efficiency, and quality of clinical trials by establishing standardized educational competencies and training across the CTSA Consortium. The third meeting was attended by over 30 attendees representing more than 25 institutions and organizations, with the goal of harmonizing 51 competency statements into a single competency framework that will serve as the foundation for a national training curriculum for investigators and study coordinators involved in clinical trials. 

      Using the competency framework created by the Joint Task Force (JTF) for Clinical Competency as a foundation, the ECRPTQ project brought together representatives of the! entire CTSA consortium to refine the competencies and develop related assessments. This work also involved collaboration with members of the Joint Task Force, the Consortium for Academic Programs in Clinical Research, and the Association of Clinical Research Professionals. 

      Vicki Ellingrod served as a neutral facilitator for the one-day event, and Tom Shanley returned from his very busy new role at Northwestern to chair the meeting. Members of the Workforce Development Domain Task Force (WD DTF) leadership team sent delegates and and NCATS representatives, Todd Wilson and Michelle Culp, were also in attendance. A revised framework of clinical trial competencies will be validated by before being sent to NCATS as the meeting deliverable. We are grateful to MICHR leadership and staff for hosting the meeting and thank the attendees for traveling to Ann Arbor, MI for this important event.

    • More to come per timeline presented in earlier bullets

Related Publications:

None to date