<abstract xmlns="http://www.w3.org/1999/xhtml">

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

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

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

Chair of Management Processes, Faculty of Management

Department of Scientific Research and International Cooperation, Division Clinical Trials

Journal of Economics and Management

This work is licensed under the Creative Commons Attribution-NonCommercial 4.0 International License.

Aim/purpose – The purpose of this paper is to clarify the certification process of the Good Clinical Practice (GCP) competencies based on a comparison with the...

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

Pubblicato online: 18 giu 2021

Pagine: 179 - 205

Ricevuto: 10 ott 2020

Accettato: 20 mag 2021

DOI: https://doi.org/10.22367/jem.2021.43.09

Parole chiave
project management, clinical trials, certification, Good Clinical Practice, GCP

© 2021 Marek Zawada et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial 4.0 International License.

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

Pubblicato online: 18 giu 2021

Pagine: 179 - 205

Ricevuto: 10 ott 2020

Accettato: 20 mag 2021

DOI: https://doi.org/10.22367/jem.2021.43.09

Parole chiaveproject management, clinical trials, certification, Good Clinical Practice, GCP

© 2021 Marek Zawada et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial 4.0 International License.

Parole chiave
project management, clinical trials, certification, Good Clinical Practice, GCP