Module 1: Quiz about GCP history and principles

GCP is a set of rules originally intended for the clinical treatment of patients at a hospital.

Yes

What are the purposes of GCP?

To protect the subject’s right, safety and well-being.

To ensure that the clinical trial data are credible.

To increase the number of medicinal products on the market.

If a sponsor does not have a robust quality system to ensure compliance with ICH GCP (e.g. Inadequate instruction and training), which GCP principle does this sponsor deviate from?

Principle 1

Principle 10

Principle 13

What is GCP principle 3 about?

Protocol

The rights, safety and well-being of the trial subjects are the most important considerations.

Medical care of subjects

Which of following principles is the most challenging for the investigator and site staff?

Principle 6

Principle 8

Principle 11

Is it acceptable not to follow the procedure as described in the protocol?

Yes - only when it is necessary to eliminate immediate hazards to the subjects.

Dr. Jackson wrote the protocol and submitted the application to the authority. Dr. Jackson is responsible for the initiation and management of the trial and is also the investigator conducting the trial. The investigational medicinal product was supplied by a private pharmaceutical company. Who is Dr. Jackson?

Sponsor

Investigator

Sponsor-investigator

Dr. Hansen provided advice in developing the protocol and conducted the trial for a pharmaceutical company. The company was responsible for the initiation, application, management and financing of the trial. Who is Dr. Hansen?

Sponsor

Investigator

Sponsor-investigator

What is GCP principle 9 about?

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

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

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

If a local regulatory authority has more strict regulations than GCP, the local regulations need not to be followed.

True

False

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Module 1: Quiz about GCP history and principles

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