Enhancing ethical standards: a quantitative analysis of knowledge improvement a through structured good clinical practice workshop

Narasimha Murthy K. Muthahanumaiah; Manjunath G. Narasimahaiah; Swamy R. Mallikarjuna; Pesala Pavan Kumar Reddy

doi:10.18203/2319-2003.ijbcp20253372

Authors

Narasimha Murthy K. Muthahanumaiah Department of Pharmacology, Sri Siddhartha Medical College, Tumkur, Karnataka, India https://orcid.org/0000-0001-9999-652X
Manjunath G. Narasimahaiah Department of Pharmacology, Sri Siddhartha Medical College, Tumkur, Karnataka, India
Swamy R. Mallikarjuna Department of Pharmacology, Sri Siddhartha Medical College, Tumkur, Karnataka, India
Pesala Pavan Kumar Reddy Department of Pharmacology, Sri Siddhartha Medical College, Tumkur, Karnataka, India https://orcid.org/0009-0002-9968-6390

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20253372

Keywords:

Ethical principles, Good clinical practice, Postgraduate, Research

Abstract

Background: Good clinical practice (GCP) is an internationally recognized ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. In India, postgraduate medical students are mandated to take part in research projects as part of their academic curriculum, but a lack of training leads to considerable disparity in their understanding of GCP principles. A structured educational intervention like the GCP workshop helps in filling these disparities and promotes the conduction of ethical research.

Methods: An educational interventional study was conducted to assess the impact of a GCP workshop on knowledge among postgraduate medical students during a one-day GCP workshop at a tertiary care teaching hospital. A total of 163 students participated in the study. A self-developed, pre-validated questionnaire was used to assess the impact of knowledge before and after the workshop. Data was collected using Google forms and analysed by using Microsoft Excel and Jeffreys’s Amazing Statistics Program (JASP) software.

Results: Out of 163 participants, 158 postgraduate students completed both pre- and post-tests. The mean pre-test score was 22.3±3.5, which increased to 24.5±0.9 in the post-test. To assess the normality of data distribution, the Shapiro-Wilk test was performed and resulted in p<0.001, indicating the use of a nonparametric test. Then the Wilcoxon signed-rank test was performed, and results indicated statistically significant improvement (Z=7.48, p<0.001). Question-wise analysis revealed an increase in accuracy from 87.06% to 98.36%, indicating improvement in knowledge across the questionnaires.

Conclusions: The overall findings suggest that a structured good clinical practice (GCP) workshop plays a significant, important role in enhancing knowledge among postgraduate medical students.

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References

McNair L. Ethical and regulatory oversight of clinical research: The role of the Institutional Review Board. Exp Biol Med (Maywood). 2022;247(7):561–6. DOI: https://doi.org/10.1177/15353702221078216

Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008;4(1):e5. DOI: https://doi.org/10.2349/biij.4.1.e5

Mentz RJ, Hernandez AF, Berdan LG, Rorick T, O’Brien EC, Ibarra JC, et al. Good Clinical Practice guidance and pragmatic clinical trials: Balancing the best of both worlds: Balancing the best of both worlds. Circulation. 2016;133(9):872–80. DOI: https://doi.org/10.1161/CIRCULATIONAHA.115.019902

Jadhav M, Bhatt A. Ethics in clinical research in India: A survey of clinical research professionals’ perceptions. Perspect Clin Res. 2013;4(1):4–8. DOI: https://doi.org/10.4103/2229-3485.106368

Burt T, Sharma P, Dhillon S, Manchanda M, Mittal S, Trehan N. Clinical research environment in India: Challenges and proposed solutions. J Clin Res Bioeth. 2014;5(6):1–8.

Harshita H, Panda PK. Study on good clinical practices among researchers in a tertiary healthcare institute in India. World J Methodol. 2023;13(5):466–74. DOI: https://doi.org/10.5662/wjm.v13.i5.466

Vimal M, Nishanthi A, Kagne RN. Implementation of research ethics training for postgraduate medical students - A learner-centered approach. Perspect Clin Res. 2023;14(2):102–3. DOI: https://doi.org/10.4103/picr.picr_135_22

Johar SK, Jaybhaye DL, Chandra S, Mishra PS. Evaluation of knowledge, attitude and practices of postgraduate medical students towards clinical research in a tertiary care teaching hospital. Int J Basic Clin Pharmacol. 2021;10(7):800. DOI: https://doi.org/10.18203/2319-2003.ijbcp20212376

Chellaiyan VG, Manoharan A, Jasmine M, Liaquathali F. Medical research: Perception and barriers to its practice among medical school students of Chennai. J Educ Health Promot. 2019;8(1):134. DOI: https://doi.org/10.4103/jehp.jehp_464_18

Mondal H, Mondal S. A brief review on good clinical practice and its training methods. Indian Dermatol Online J. 2024;15(3):377–82. DOI: https://doi.org/10.4103/idoj.idoj_603_23

Dharmendra MY, Bhavsar B, Prajapati VD, Malhotra S. Perception of medical students regarding clinical trials and its impact after educational intervention – A questionnaire-based study. Apollo Med. 2024. DOI: https://doi.org/10.1177/09760016241296196

Goel D, Walia R, Sharma P, Kaur H, Agnihotri P. Impact of educational intervention on knowledge, attitude and awareness of good clinical practice among health care providers. Perspect Clin Res. 2017;8(2):90–4. DOI: https://doi.org/10.4103/2229-3485.203045

Sukriti SM, Ajay AG, Vinay VB. Perception and Attitude of Post Graduate Students towards Research and Audit of Their Thesis Protocol- A Cross Sectional Study.. Journal of Contemporary Clinical Practice. 2025 Jul;11(7):337-346.

Vora M, Shah C. Effectiveness of workshop training in basic principles of Good Clinical Practice among the Medical teachers - A cross sectional study. Natl J Physiol Pharm Pharmacol. 2011;2(1):92. DOI: https://doi.org/10.5455/njppp.2011.v1.i2.9

Patel A, Padarya SK, Virani A, Singh P. Evaluating the impact of a Good clinical practice workshop on the knowledge and attitude of postgraduate medical students. Cureus. 2025;17(2):e79674. DOI: https://doi.org/10.7759/cureus.79674

Kumar S, Maity S, Mondal H, Banerjee M, Das A. Impact of GCP workshop in improving knowledge about good clinical practice among participants attending GCP Workshop at Government Medical College, India. J Med Allied Sci [Internet]. 2025;15(1):20. DOI: https://doi.org/10.5455/jmas.213759

Awatagiri K, Gadgil D, Kannan S, Rane P, Bandekar B, Sawant N, et al. Effect of a planned training session on good clinical practice knowledge in research professionals: A pilot study. Perspect Clin Res. 2019;10(1):20–5. DOI: https://doi.org/10.4103/picr.PICR_146_17

Sureshbabu, Syamala Shanthi Kumari.B.S, Lakshmana Chintala, N.P.Sirisha. Impact of Educational Intervention on Knowledge, Attitude and Awareness of Good Clinical Practice among Health Care Providers. Perspect Clin Res. 2019;18(3):62–5.

Biswas A, Sen S, Ray K. Reliability assessment of pre -post test questionnaire on the impact of a daylong clinical pharmacology workshop among medical professionals. Asian J Med Sci. 2019;10(6):93–7. DOI: https://doi.org/10.3126/ajms.v10i6.25448