Abstract
Background: There is a significant lack of research regarding the knowledge, perception and attitude of health care professionals towards compliance with Good Clinical Practice (GCP) within the entire Arabic world. The present study intends to assess health care professionals' knowledge, perception, and attitude towards compliance with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines.
Methods: A cross-sectional study was conducted at King Abdullah International Medical Research Center (KAIMRC) and King Abdulaziz Medical City (KAMC) in Riyadh. A self-administered questionnaire was used to assess the knowledge, perception, and attitude towards ICH-GCP in a sample of 78 health care professionals.
Results: The vast majority of the respondents 55(71%) were principal or co-investigators and 23(29%) were research coordinators. Almost all, 66(85%), of the respondents had received GCP training. Of 78 health care professionals, 98% reported that the research subjects provide voluntary consent and the study protocols give a clear and adequate description of the study procedures. 97% reported that GCP principles are followed in clinical trial studies and GCP compliant activities improve the quality of clinical research. Only 57% of the health care professionals reported that clinical research is a part of routine activities done in the clinic. 72% reported that they suffer from delay in the approval by the national IRB to start their research and 59% reported negative attitude towards the IRB approval process or monitoring and audit of the clinical trials.
Conclusion: The present study suggests that the level of knowledge and perception towards compliance with ICH-GCP are generally satisfactory among health care professionals who involved in clinical trials in Saudi Arabia.