Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. It is of utmost importance that this standard is upheld at all times when research involving human are conducted. In so doing, all those who are involved in clinical trials will provide the assurance that the rights, safety and well-being of the study subjects are safeguarded; in keeping with the principles that have their origin in the Declaration of Helsinki.
The objective of the Malaysian GCP Guideline is to ensure that all drug related clinical trials conducted in Malaysia are in accordance with the highest international ethical and scientific standards while at the same time taking into consideration the national issues and local realities without compromising the standards.
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