GCP (Good Clinical Practice) regulations and E6 guidelines require that clinical studies be reviewed before they start, during the study proper, and at completion or termination. Stakeholders are required to protect human subjects throughout the course of the study as well as to ensure that study objectives are met. Good working relationships among stakeholders which include the sponsor, IRB, FDA and principal investigator, are essential for meeting trial goals in a timely and cost-efficient manner. When deviations or nonconformances are found during an audit, prompt corrective action and sustainable remedies must be implemented.

GCP (Good Clinical Practice) regulations and E6 guidelines require that clinical studies be reviewed before they start, during the study proper, and at completion or termination. Stakeholders are required to protect human subjects throughout the course of the study as well as to ensure that study objectives are met. Good working relationships among stakeholders which include the sponsor, IRB, FDA and principal investigator, are essential for meeting trial goals in a timely and cost-efficient manner. When deviations or nonconformances are found during an audit, prompt corrective action and sustainable remedies must be implemented.