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GCP in the regular practice of medicine means the Good Clinical Practice that is part and parcel of the everyday practice of proper medicine. GCP in research has a different meaning, however. It refers to compliance with specific regulations and guidelines that govern human medical research.
The 13 Principles of ICH GCP (International Conference on Harmonization Good Clinical Practice) are as follows:
- Principle 1: Trials should be conducted with ethical principles that come from the Declaration of Helsinki.
- Principle 2: Risks, benefits and alternative procedures need to be weighed prior to designing and beginning a trial and discussed in detain with the prospective research subject volunteer.
- Principle 3: The rights, safety and welfare of the research subject volunteer override the interests of the study, society and science. The advancement of medicine is never the most important factor in research; therefore investigators must never sacrifice the interests and rights of study subjects to ensure completion of a trial.
- Principle 4: The proposed study should be based on sound scientific data.
- Principle 5: The need of the ICF (Informed Consent Form) prior to beginning any IND (Investigational New Drug) trial to describe in detail the negative things that are possible including an inconvience and side effects especially common ones and severe ones.
- Principle 6: IRB (Institutional Review Board)/IEC (Independent Ethics Committee) approval prior to beginning.
- Principle 7: Medical care is delivered by a qualified licensed physician.
- Principle 8: The PI (Principle Investigator) is responsible for maintaining a well trained medical research staff.
- Principle 9: IC (Informed Consent) as codified in the ICF (Informed Consent Form) needs to be freely obtained from every research subject volunteer prior to beginning a trial. As new data arise the subject needs to be apprised of this also.
- Principle 10: All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification by the sponsors CRA (Clinical Research Associate) to bring to the FDA to help support the sponsors NDA (New Drug Application).
- Principle 11: HIPAA confidentiality of medical records along with blinding the subjects name from the sponsor is required to protect the subjectís privacy and maintain confidentiality in accordance with regulatory requirements.
- Principle 12: The PI (Principle Investigator) is responsible for storing the experimental study drug in a score locked area with limited access. GMP (Good Manufacturing Practice) refers to the process whereby study drugs are manufactured, handled, and stored. The PI is expected to store the study drug with GMP in mind and use it only as the protocol permits.
- Principle 13: QA (Quality Assurance) systems with procedures that assure the quality of every aspect of the trial should be implemented by the PI that are study specific to ensure the research subject volunteers get a good deal and the sponsorís CRA receives easily verifiable accurate data to support the NDA.