Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. According to article 4, sub article 11 of proclamation No. 661/2009; The Food, Medicine and Healthcare Administration and Control Authority of Ethiopia is responsible to authorize conducting of clinical trial, monitor the process as to its conduct in accordance with good medical procedure, evaluate the results and authorize the use of the result in such a way that it benefits the public; suspend or stop the clinical trial where necessary. Articles 15 of this proclamation also provides detail requirements for the clinical trial approval procedures. In addition, articles 22-28 of the Food, Medicine and Healthcare Administration and Control Council of Ministers Regulation No. 299/2013 provides a detail description of responsibilities and activities of the Authority, Ethical Committee Advisory Board, Researchers and/or the sponsors and subjects that need to be included and not included in clinical trials. Accordingly, clinical trial studies must undergo review by the Authority for use of the investigational product or intervention in human subjects, to ensure that the study is appropriately designed to meet its stated objectives, according to all applicable laws and regulation and procedures of the country. The conduct of the trial is subject for inspection at initiation time, during conduct and at the end of trial based on different conditions at different times by the authority. The purpose of this guideline is to provide with clearly articulated standards of good clinical practice in research that are also relevant to local realities and contexts and to ensure that clinical trials conducted on human participants are designed and conducted according to sound scientific and ethical standards within the framework of good clinical practice. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected; consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The guideline was developed with consideration of the current good clinical practices of the World Health Organization (WHO) and International Council for Harmonization (ICH).