Good Clinical Practice
What is Good Clinical Practice (GCP)?
Clinical trials are conducted according to Good Clinical Practices.
GCP Principles ensure that:
- All trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH-GCP).
- Benefits outweigh risks for each patient.
- Rights, safety and well-being of patients prevail over science.
- All available non-clinical and clinical information on any investigational agent can support the trial as designed.
- All trials are scientifically sound and clearly described.
- All clinical trials have current Institutional Review Board approval.
- Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians and, if applicable, dentists.
- Everyone involved in the clinical trial is qualified by training, education and experience.
- Informed consent is given freely by every participant.
- All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
- Confidentiality of subjects is respected and protected.
- Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling.
- Systems to ensure quality are implemented in all aspects of the trial.
Federal Regulations require that sponsors of clinical studies select individuals who are qualified by training and/or experience to monitor their studies per Good clinical practice (GCP) and local regulations. It also states that Monitors be appropriately trained, and their qualifications documented. In the United States, the rules are codified in Title 21 of the Code of Federal Regulations. In the European Union these guidelines are part of EudraLex. In India he / she requires knowledge about schedule Y amendments in drug and cosmetic act 1945.