L9: Good clinical practice

Question 1

what does GCP stand for?

Answer 1

good clinical practice. the international ethical and scientific quality standard for designing, conducting and reporting clinical trials that involve human subjects

Question 2

GCP only covers phase IV clinical trials. T/F?

Answer 2

False. it covers phase I-IV clinical trials

Question 3

main focus of GCP [3]

Answer 3

1. protect human rights in clinical trial
2. provide assurance of safety of newly developed pdt
3. define role and responsibilities of people involved

Question 4

why was the US Food drugs and cosmetic act enacted?

Answer 4

there were dangerous over the counter drugs sold eg. Grandma’s secret.

Question 5

what change did the US Food drugs and cosmetic act 1938 bring about?

Answer 5

Change: manufacturers are required to do t test for safety and report to FDA before marketing

Question 6

how did the Nuremberg Code 1947 come about?

Answer 6

a group of german physicians experimented on WW2 prisoners in nazi camps–> highlighted how there is a need for scientific basis for research on human subjects + volunteer consent and protection of human subjects

Question 7

key points from the Nuremberg Code [4]

Answer 7

1. require voluntary, well-informed understanding consent of human subject
2. should aim at +ve results and based on previous knowledge that justifies expt
3. need to avoid unnecessary physical and mental suffering of subjects
4. human subjects must be free to quit expt at any point OR medical staff to stop expt if they observe that continuing is dangerous

Question 8

who created Declaration of Helsinki?

Answer 8

world medical association

Question 9

what is Declaration of Helsinki created for?

Answer 9

• started when limb deformities observed from maternal thalidomide use
  create ethical principles to guide physicians and participants in research
• informed consent/respect, risk-benefit assessment, selection of subjects of research

Question 10

what did the Tuskegee Syphilis expt highlight? [3]

Answer 10

the need to uphold ethics, justice and respect

Question 11

3 main aspects of Belmont Report

Answer 11

1. Respect for persons: protect person’s dignity and freedom/autonomy ==> NEED CONSENT
2. Beneficence: researchers should MAXIMISE BENEFITS and minimise harm
3. Justice: equitable selection and recruitment and fair treatment of human subjects

Question 12

what did the International Guidelines for Biomedical research involving human research bring about?

Answer 12

WHO and CIOMS helped developing countries apply the Nuremberg Code and Declaration of Helsinki

Question 13

what does ICH GCP stand for?

Answer 13

International Conference on Harmonisation’s (ICH) Guideline for good clinical practice

Question 14

what does ICH GCP aim to do?

Answer 14

overcome inconsistencies in GCP internationally. streamline data used by countries eg. if country A conduct trial according to ICH GCP, country B will be able to use data from that trial

Question 15

state the 13 principles of GCP

Answer 15

Ethics [3]
1. follow ethical principles that originate from Declaration of Helsinki and that of GCP and applicable regulatory requirements
2. before trial starts, need to weigh risk and inconveniences against benefits [must justify benefits over risks]
3. MUST consider rights, safety and well-being of human
subject

Protocol and science [2]:
4. need to support trial w clinical and non-clinical info
5. clinical trials shld be clinically sound and described in clear detailed protocol

Responsibilities:[3]
6. comply with protocol received prior to MCRC an hospital EC approval
7. only qualified physicians are responsible for medical care and decisions of subjects
8. person conducting trial MUST BE QUALIFIED by education, training and experience

INformed consent [1]: subject need to give consent

Data quality and integrity of trial [2]: all trial info must be recorded/handled/interpreted accurately + CONFIDENTIALITY

Question 16

13 Principles of GCP: ethics [3]

Answer 16

1. follow ethical principles that originate from Declaration of Helsinki and that of GCP and applicable regulatory requirements
2. before trial starts, need to weigh risk and inconveniences against benefits [must justify benefits over risks]
3. MUST consider rights, safety and well-being of human
   subject

Question 17

13 principles of GCP: Protocol and science [2]

Answer 17

4. need to support trial w clinical and non-clinical info
5. clinical trials shld be clinically sound and described in clear detailed protocol

Question 18

principles of GCP: responsibilities [3]

Answer 18

6. comply with protocol received prior to MCRC an hospital EC approval
7. only qualified physicians are responsible for medical care and decisions of subjects
8. person conducting trial MUST BE QUALIFIED by education, training and experience

Question 19

Principles of GCP: data quality and integrity [2]

Answer 19

Data quality and integrity of trial [2]:
-all trial info must be recorded/handled/interpreted accurately
- CONFIDENTIALITY

Question 20

principles of GCP: investigational pdts [1]

Answer 20

pdts should be manufactured, handled and stored accordance with applicable GMP

Question 21

principles of GCP: quality control/assurance [1]

Answer 21

need to implement systems with procedures that assure the quality of EVERY ASPECT of trial

Question 22

key issues with investigational product [3]

Answer 22

-LEAD creation
- must be GMP
- have pre-clinical testing

Question 23

key issues faced by investigator

Answer 23

• conduct trial based on Helsinki and ICP
• need to apply for approval

Question 24

key issues faced by regulators [state regulators in SG]

Answer 24

review ethics [IRB & MOH]

Question 25

issues faced by participants

Answer 25

informed consent

Question 26

key issues faced by sponsors

Answer 26

need to prepare trial protocol [objective, design, methods, stats considerations and organisation]