13 Principles of GCP Flashcards
1) Ethical Princples
Clinical Trial should be conducted in accordance with the ethical principles of the DoH, and consistent with GCP and appropriate regulatory requirements
2) Risks and Benefits
Before a trial is initiate, foreseeable risks should be weighed against anticipated benefits for the individual trial subject and other present future trial subjects. A trial should be initiated and continued only if the anticipated benefits justify the risks
3) Patient rights
The rights, safety and well-being of trial subjects are the most important considerations and should prevail in the interests of science and society
4) Relevant drug information
Available clinical information and non-clinical information on IP should be adequate to support the proposed CT
5) Scientific basis
CT should be scientifically sound and described in a clear detailed protocol
6) Ethics Approval
A trial should be conducted in compliance with the protocol that has received prior ethics committee approval
7) Responsible Dr
The medical care given to and medical decisions made on behalf of the subject should be the responsibility of a qualified physician
8) Education
Each individual involved in conducting a CT should be qualified by education, training, and experience relevant to their task
9) Consent
Freely given informed consent should be obtained from every subject prior to CT participation
10) Data
All CT information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification
11) confidentiality
The confidentiality of records that could ID subjects should be protected in accordance with the applicable regulatory requirements
12) Manufacturing
Drug should be manufactured, handled and stored in accordance with applicable GMP. They should be used in accordance with the approved protocol
13) Quality
Systems that ensure the quality of every aspect of the trial should be implemented.
