E6: 13 PRINCIPLES OF GCP

Question 1

13 PRINCIPLES OF GCP

2.1

Answer 1

Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

Question 2

13 PRINCIPLES OF GCP

2.2

Answer 2

Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

Question 3

13 PRINCIPLES OF GCP

2.3

Answer 3

The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

Question 4

13 PRINCIPLES OF GCP

2.4

Answer 4

The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

Question 5

13 PRINCIPLES OF GCP

2.5

Answer 5

Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

Question 6

13 PRINCIPLES OF GCP

2.6

Answer 6

A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.

Question 7

13 PRINCIPLES OF GCP

2.7

Answer 7

The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

Question 8

13 PRINCIPLES OF GCP

2.8

Answer 8

Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

Question 9

13 PRINCIPLES OF GCP

2.9

Answer 9

Freely given informed consent should be obtained from every subject prior to** clinical trial participation.**

Question 10

13 PRINCIPLES OF GCP

2.10

Answer 10

All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

Question 11

13 PRINCIPLES OF GCP

2.11

Answer 11

The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

Question 12

13 PRINCIPLES OF GCP

2.12

Answer 12

Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

Question 13

13 PRINCIPLES OF GCP

2.13

Answer 13

Systems with procedures that assure the quality of every aspect of the trial should be implemented.