ICH-GCP Protocol

Clinical studies refer to the evaluation of clinical trials conducted to enable data to collected for health interventions. Such studies follow the ICH-GCP, or International Conference on Harmonisation - Good Clinical Practice protocol.

ICH

• The International Conference of Harmonisation, also called the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, refers to a project comprised of regulatory authorities and pharmaceutical experts from the United States, Japan and Europe. The ICH is designed to establish protocols for pharmaceutical product development and registration.

GCP

• GCP, or Good Clinical Practice, refers to an international quality standard provided by the ICH for the purpose of regulating clinical trials that involve human subjects. GCP standards offer assurance as to the effect and safety of compounds developed in clinical trials, human rights protection of trial participants, and also define the roles of clinical research investigators, clinical trial sponsors and clinical research associates.

ICH-GCP Protocol

• The clinical trial protocol, as defined by the ICH-GCP, contains a study plan for the clinical trial, describes who may participate in the trial and offers a schedule of procedures, tests, medications, dosages and trial length. The clinical trial protocol also describes methodology, statistical consideration, organization and offers such background information as to why the trial is being conducted.