GOOD CLINICAL PRACTICE Flashcards
how did the FDA come about?
pure food and drug act which also brought in US federal law, labelling of habit-forming drugs
what led to the office for human research protections (OHRP)?
tuskegee syphilis experiment
how did the 1938 federal food, drug and cosmetic act come about?
Elixir sulfanilamide was a improperly
prepared and caused mass poisoning in US,
1937 - more than 100 deaths
what replaced the pure food and drug act?
federal food, drug and cosmetic act replaced it and it gave authority to FDA to oversee the safety of food, drugs, and cosmetics
what is the nuremberg code and how did it come about?
a set of ethics principle for human experimentation as a result of the Subsequent Nuremberg Trials at the end of the WWII which emphasizes on informed consent and absence of coercion
how did the willowbrook state school hepatitis study come about?
Healthy children were intentionally inoculated
orally or by injection, with the virus that cause
hep A, then they were monitored to gauge the
effects of gamma globulin in combating it.
why was thalidomide withdrawn?
Introduced as a sedative drug in late 1950s
- causes birth defects which affected 10 000 - 20 000
- led to stricter testing for drugs before they can be
licensed
what is the declaration of helsinki?
- Developed by the World Medical Association
- A set of ethical principles for the medical community
- The Declaration is morally binding on physicians and that obligation overrides any national or local laws or regulations, if the declaration provides for a higher standard of protection
what is the belmont report?
Prompted in part by Tuskegee Syphilis Study 3 fundamental ethical principles ◦ Respect for Persons ◦ Beneficence ◦ Justice
what is ich?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
- brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan and the United States
what is GCP?
- rules of conducting good, clean, ethical research.
- Originated in response to unethical, unsafe and abuse of human rights
why must adhere to GCP?
- Rights, integrity and confidentiality of research
subjects are protected (ETHICS) - credibility of the data (QUALITY DATA)
- Standardise the conduct of clinical trials across world regions, so that clinical trial data could be universally accepted
what is the purpose of GCPs?
- Make most efficient use of human, animal and
material resources - Improve public health - achieve earlier availability of
new treatments
what is QSEM in ICH?
Quality - Stability testing, GMP
Safety - toxicology testing, pharmacology studies
Efficacy - Safety Data Management, GCP
Multidisciplinary - medical terminologies
what is in ICH?
8 chapters, 61 definitions and 13 high level statements based on declaration of helsinki
what is GCP legislation?
- To ensure that trials of new products in humans are performed ensuring the least amount of harm to participants
- To ensure that the safety and efficacy of the product is
adequately demonstrated
what is protocol?
A document that describes the objective(s), design,
methodology, statistical considerations, and
organization of a trial
what is sponsor?
An individual, company, institution, or organization
which takes responsibility for the initiation,
management, and/or financing of a clinical trial
what is CRO?
CONTRACT RESEARCH ORGANIZATION
- A person or an organization contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions
what is CRA?
CLINICAL RESEARCH ASSOCIATE
- Person employed by Sponsor / CRO to conduct
monitoring
- The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirement(s).
what is investigator?
A person responsible for the conduct of the clinical
trial at a trial site
- If a trial is conducted by a team of individuals at a
trial site, the investigator is the responsible leader of
the team and may be called the principal investigator
(PI)
what is a doctor and investigator?
doctor : A person trained in the healing arts and licensed to practice
investigator : One who searches diligently into a subject - physician, dentist, nutrionist
what is subject?
An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control
what are RA?
bodies having the power to regulate
- review submitted clinical data and those that conduct inspections
- In SG : HSA
