Good Clinical Practice (GCP) (Healthcare)

Medical Lab General Courses

Target Level

• It is essential for anyone taking part in the running of clinical research and trials.
• It is important that everyone involved in research is trained or appropriately experienced to perform the specific tasks they are being asked to undertake.

Description

• Good clinical practice (GCP) is an international ethical and scientific guideline for clinical research which includes designing, planning, conducting, monitoring, recording, and reporting of biomedical studies or trials that involve human participants.
• GCP ensures that the studies are carried out in a scientific and ethical manner. These guidelines have two important principles, namely, protection of rights of human participants and the credibility of data generated.
• The central objective of GCP in human studies is to give priority to the well-being of human participants. The interest of science and society should not be above the wellbeing of the participants.
• Adherence to GCP guidelines by the researcher provides public confidence that the rights, safety, and well-being of human participants involved in research are protected.
• It has been observed that researchers require basic GCP training and to strengthen the knowledge and awareness regarding GCP. Considering this, we had decided to conduct a training session on an overview of GCP.

Objectives and Expected Results

This course of training was found to be significant in improving the knowledge base of participants, especially investigators, and study coordinators learning about GCP Element:

• What Good Clinical Practice (GCP) is
• The basic principles of GCP
• What being ‘GCP’ qualified means and why conducting a study according to GCP is important
• The responsibilities of the investigator
• How GCP should be adopted in the conduct of clinical research
• Investigator’s qualifications and agreements
• Adequate resources
• Medical care of trial subjects
• Communication with IRB/IEC
• Compliance with protocol
• Investigational product(s)
• Randomization procedures and unblinding
• Informed consent of trial subjects
• Records and reports
• Progress reports
• Safety reporting
• Premature termination or suspension of a trial
• Final report(s) by investigator/institution

Others Training Materials

Workshop, Sheets, and case studies paper will be conducted and implemented during training.

Target group