Enhancing Clinical Research Professionals’ Training and Qualifications Training Gaps by Competency Domains Domain Competency Working Groups were asked to identify training that met the competencies and to highlight training gaps that exist. One hundred and fourteen training gaps were identified among the 9 competency domains. Of these, 5 primary categories were identified. These included A) training that is needed but doesn’t currently exist; B) existing training that is not adequate; C) certification, documentation of skill, or formal assessment needed; D) a core training curriculum needs to be defined and/or developed; and E) not enough training at a level for clinical research coordinators. The number of gaps in each category is shown below. Overwhelmingly, the groups concluded that training does currently exist for most competency domains, but is not adequate. Some groups emphasized the need for certification for research team members prior to conducting clinical trials. In addition, groups noted the lack of comprehensive training for CRCs. Competency A B C D E Gaps Domain Training Existing Certification, Core training Not Identified doesn’t exist training is documentation, curriculum needs enough per Work not or formal to be training for (# gaps identified) Group adequate assessment is defined/developed CRCs (# needed gaps identified) (# gaps identified) (# gaps identified) (# gaps identified) Scientific 3 6 5 2 3 19 Concepts & Research Design Ethical & 2 1 0 0 0 3 Participant Safety Considerations Investigational 4 11 1 0 0 16 Products Development & Regulation 11 20 0 0 0 31 Clinical Trials Operations (GCPs) Study & Site 1 11 0 0 5 17 Management Data 4 8 0 0 0 12 Management &Informatics Leadership & 5 0 2 0 0 7 Professionalism Communication 6 2 0 0 1 9 Teamwork 0 0 0 0 0 0 TOTAL 36 59 8 2 9 114
Enhancing Clinical Research Professionals’ Training and Qualifications Training Gaps by Competency Domains Domain Competency Working Groups were asked to identify training that met the competencies and to highlight training gaps that exist. One hundred and fourteen training gaps were identified among the 9 competency domains. Of these, 5 primary categories were identified. These included A) training that is needed but doesn’t currently exist; B) existing training that is not adequate; C) certification, documentation of skill, or formal assessment needed; D) a core training curriculum needs to be defined and/or developed; and E) not enough training at a level for clinical research coordinators. The number of gaps in each category is shown below. Overwhelmingly, the groups concluded that training does currently exist for most competency domains, but is not adequate. Some groups emphasized the need for certification for research team members prior to conducting clinical trials. In addition, groups noted the lack of comprehensive training for CRCs. Competency Domain A Training doesn’t exist (# gaps identified) B Existing training is not adequate (# gaps identified) C Certification, documentation, or formal assessment is needed (# gaps identified) D Core training curriculum needs to be defined/developed (# gaps identified) E Not enough training for CRCs (# gaps identified) Gaps Identified per Work Group Scientific Concepts & Research Design 3 6 5 2 3 19 Ethical & Participant Safety Considerations 2 1 0 0 0 3 Investigational Products Development & Regulation 4 11 1 0 0 16 Clinical Trials Operations (GCPs) 11 20 0 0 0 31 Study & Site Management 1 11 0 0 5 17 Data Management &Informatics 4 8 0 0 0 12 Leadership & Professionalism 5 0 2 0 0 7 Communication 6 2 0 0 1 9 Teamwork 0 0 0 0 0 0 TOTAL 36 59 8 2 9 114
ECRPTQ-training-gaps-052915-ncn.docx