L9: Good clinical practice Flashcards
what does GCP stand for?
good clinical practice. the international ethical and scientific quality standard for designing, conducting and reporting clinical trials that involve human subjects
GCP only covers phase IV clinical trials. T/F?
False. it covers phase I-IV clinical trials
main focus of GCP [3]
- protect human rights in clinical trial
- provide assurance of safety of newly developed pdt
- define role and responsibilities of people involved
why was the US Food drugs and cosmetic act enacted?
there were dangerous over the counter drugs sold eg. Grandma’s secret.
what change did the US Food drugs and cosmetic act 1938 bring about?
Change: manufacturers are required to do t test for safety and report to FDA before marketing
how did the Nuremberg Code 1947 come about?
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
key points from the Nuremberg Code [4]
- require voluntary, well-informed understanding consent of human subject
- should aim at +ve results and based on previous knowledge that justifies expt
- need to avoid unnecessary physical and mental suffering of subjects
- human subjects must be free to quit expt at any point OR medical staff to stop expt if they observe that continuing is dangerous
who created Declaration of Helsinki?
world medical association
what is Declaration of Helsinki created for?
- 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
what did the Tuskegee Syphilis expt highlight? [3]
the need to uphold ethics, justice and respect
3 main aspects of Belmont Report
- Respect for persons: protect person’s dignity and freedom/autonomy ==> NEED CONSENT
- Beneficence: researchers should MAXIMISE BENEFITS and minimise harm
- Justice: equitable selection and recruitment and fair treatment of human subjects
what did the International Guidelines for Biomedical research involving human research bring about?
WHO and CIOMS helped developing countries apply the Nuremberg Code and Declaration of Helsinki
what does ICH GCP stand for?
International Conference on Harmonisation’s (ICH) Guideline for good clinical practice
what does ICH GCP aim to do?
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
state the 13 principles of GCP
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
13 Principles of GCP: ethics [3]
- follow ethical principles that originate from Declaration of Helsinki and that of GCP and applicable regulatory requirements
- before trial starts, need to weigh risk and inconveniences against benefits [must justify benefits over risks]
- MUST consider rights, safety and well-being of human
subject
13 principles of GCP: Protocol and science [2]
- need to support trial w clinical and non-clinical info
- clinical trials shld be clinically sound and described in clear detailed protocol
principles of GCP: responsibilities [3]
- comply with protocol received prior to MCRC an hospital EC approval
- only qualified physicians are responsible for medical care and decisions of subjects
- person conducting trial MUST BE QUALIFIED by education, training and experience
Principles of GCP: data quality and integrity [2]
Data quality and integrity of trial [2]:
-all trial info must be recorded/handled/interpreted accurately
- CONFIDENTIALITY
principles of GCP: investigational pdts [1]
pdts should be manufactured, handled and stored accordance with applicable GMP
principles of GCP: quality control/assurance [1]
need to implement systems with procedures that assure the quality of EVERY ASPECT of trial
key issues with investigational product [3]
-LEAD creation
- must be GMP
- have pre-clinical testing
key issues faced by investigator
- conduct trial based on Helsinki and ICP
- need to apply for approval
key issues faced by regulators [state regulators in SG]
review ethics [IRB & MOH]
