An analysis of certification processes for Good Clinical Practice and project management competencies

Aim/purpose – The purpose of this paper is to clarify the certification process Good Clinical Practice (GCP) competencies based on a comparison with project management (PM) process. This aim was accomplished by model development. Design/methodology/approach study divided into three main phases: 1st phase identification key characteristics PM and GCP processes, 2nd development models for GCP, 3rd conclusions from in-depth interviews. Findings As result research, processes were identified, developed. In addition, interviews, solutions organizing way confirming knowledge guidelines proposed. Research implications/limitations proposed rules may be too complex exceed needs expectations clinical trial environment. focus stakeholder relations, without granting procedures, enable broader contextualization issues discussed in paper. analysis might fragmented as it regards sole research refers Poland only, hence will valuable identify whether foreign authorities have same attitude competency model. It recommended increase number respondents’ interviews obtain results higher validity reliability. Originality/value/contribution raises topics at crossroads management, trials, that been underdeveloped so far. significant all organizations involved conducting projects. findings contribute quality trials provide public assurance rights, safety, well-being subjects are protected data credible. Keywords: certification, Practice, GCP. JEL Classification: M10, O32, I11.