IDEAS home Printed from https://ideas.repec.org/a/vrs/jecman/v43y2021i1p179-205n8.html
   My bibliography  Save this article

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

Author

Listed:
  • Zawada Marek

    (Chair of Management Processes, Faculty of Management, Warsaw University of Technology, Warsaw, Poland)

  • Gągała Dorota

    (Department of Scientific Research and International Cooperation, Division Clinical Trials, The Children’s Memorial Health Institute, Warsaw, Poland)

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.

Suggested Citation

  • Zawada Marek & Gągała Dorota, 2021. "An analysis of certification processes for Good Clinical Practice and project management competencies," Journal of Economics and Management, Sciendo, vol. 43(1), pages 179-205, May.
    • Handle: RePEc:vrs:jecman:v:43:y:2021:i:1:p:179-205:n:8
    DOI: 10.22367/jem.2021.43.09
    as

    Download full text from publisher

    File URL: https://doi.org/10.22367/jem.2021.43.09
    Download Restriction: no
    File URL: https://libkey.io/10.22367/jem.2021.43.09?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    More about this item

    Keywords

    project management; clinical trials; certification; Good Clinical Practice; GCP;
    All these keywords.

    JEL classification:

    • M10 - Business Administration and Business Economics; Marketing; Accounting; Personnel Economics - - Business Administration - - - General
    • O32 - Economic Development, Innovation, Technological Change, and Growth - - Innovation; Research and Development; Technological Change; Intellectual Property Rights - - - Management of Technological Innovation and R&D
    • I11 - Health, Education, and Welfare - - Health - - - Analysis of Health Care Markets

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:vrs:jecman:v:43:y:2021:i:1:p:179-205:n:8. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Peter Golla (email available below). General contact details of provider: https://www.sciendo.com .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.