Good Clinical Practice

Question 1

What 2 main principles does GCP take into account?

Answer 1

1. Patient safety
2. Data integrity

Question 2

When does GCP apply?

Answer 2

The entire period from planning of a clinical trial through to the final reporting of results.

Question 3

What does GCP apply to?

Answer 3

All clinical trials in the UK involving human participants. It is not legally binding but is expected to be followed.

Question 4

What was the Nuremburg Code (1947)?

Answer 4

The first codified standard for research involving human participants.

Question 5

What are the 4 main principles of the Nuremburg Code (1947)?

Answer 5

1. Respect for autonomy
2. Research should be voluntary and non-coercive
3. Participants should receive informed consent
4. The rights of participants take precedence over society or scientific benefit

Question 6

What was the Declaration of Helsinki (1964)?

Answer 6

More extensive guidelines for the protection of subjects in medical research.

Question 7

What critiques were there of the Declaration of Helsinki (1964)?

Answer 7

The documentation was difficult to follow, there were frequent updates and it was not oriented to the process of conducting research.

Question 8

What type of clinical trials is the Declaration of Helsinki (1964) particularly relevant to?

Answer 8

Placebo-controlled trials, as the declaration states that “it is unethical to withdraw effective treatments from
patients”.

Question 9

What is the ICH-GCP (1996)?

Answer 9

The International Conference on Harmonisation of Good Clinical Practice.

Question 10

Why was the ICH-GCP (1996) developed?

Answer 10

To internationally standardise the process of human research. It replaced the CTIMP guidelines of individual countries to make designing of trials easier, quicker and more cost effective.

Question 11

What is the NIH definition of a clinical trial?

Answer 11

“Research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioural outcomes.”

Question 12

What differentiates a clinical trial from a clinical study?

Answer 12

Clinical trials:
1. Involve human participants
2. Participants are prospectively assigned to an intervention
3. The study is designed to evaluate the effect of the intervention on the participants
4. The effect being evaluated is health-related, biomedical or a behavioural outcome

Question 13

What is ethical conduct? (13 Principles of Good Practice)

Answer 13

Trials must be conducted in accordance with the ethical principles in the Declaration of Helsinki, GCP and any other regulatory requirements.

Question 14

What is risk-benefit assessment? (13 Principles of Good Practice)

Answer 14

Side-effects of the trial must be weighed against the anticipated benefits to the participants and to society.

Question 15

What is trial participants? (13 Principles of Good Practice)

Answer 15

The rights, safety and wellbeing of participants takes precedence of scientific or societal benefits.

Question 16

What is information on medicinal product? (13 Principles of Good Practice)

Answer 16

The preclinical and nonclinical information on the IMP must be adequate to support the trial.

Question 17

What is good quality trials/scientific integrity? (13 Principles of Good Practice)

Answer 17

The protocol that details the trial should be scientifically sound.

Question 18

What is protocol compliance? (13 Principles of Good Practice)

Answer 18

Investigators should follow the protocol at all times unless modifications are necessary for immediate safety concerns.

Question 19

What is medical decisions? (13 Principles of Good Practice)

Answer 19

A qualified physician (or dentist) should be responsible for all medical decisions and care related to the trial.

Question 20

What is qualified personnel? (13 Principles of Good Practice)

Answer 20

Every member of staff involved in the trial must be qualified by education, training and experience. This must be recorded.

Question 21

What is informed consent? (13 Principles of Good Practice)

Answer 21

Participants must voluntarily consent to the trial after being adequately informed of the potential benefits and risks.

Question 22

What is record keeping and reporting? (13 Principles of Good Practice)

Answer 22

All information regarding the trial should be accurately recorded, handled and stored for reporting, interpretation and verification.

Question 23

What is confidentiality? (13 Principles of Good Practice)

Answer 23

The data of participants must be protected and their identities kept private unless legally required.

Question 24

What is good manufacturing process (GMP)? (13 Principles of Good Practice)

Answer 24

IMPs should be manufactured, handled and stored in accordance with GCP.

Question 25

What is quality systems? (13 Principles of Good Practice)

Answer 25

Systems should be in place to assure the quality of all aspects of the trial.

Question 26

What are the Medicines for Human Use (Clinical Trials) Regulations (2004)?

Answer 26

A law on clinical trials adopted across the EU in 2004 and incorporated into the law of the UK in the Medicines Act.

Question 27

What is the MHRA?

Answer 27

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the national oversight body to ensure the safe and appropriate use of medicinal products and medical devices in the UK.

Question 28

What are the MHRA responsible for?

Answer 28

The MHRA are responsible for approving research and for conducting inspections of clinical trial sites.

Question 29

What is GCP?

Answer 29

An international ethical, scientific and quality standard by which all clinical research involving humans is conducted.