GOOD CLINICAL PRACTICE

Question 1

how did the FDA come about?

Answer 1

pure food and drug act which also brought in US federal law, labelling of habit-forming drugs

Question 2

what led to the office for human research protections (OHRP)?

Answer 2

tuskegee syphilis experiment

Question 3

how did the 1938 federal food, drug and cosmetic act come about?

Answer 3

Elixir sulfanilamide was a improperly
prepared and caused mass poisoning in US,
1937 - more than 100 deaths

Question 4

what replaced the pure food and drug act?

Answer 4

federal food, drug and cosmetic act replaced it and it gave authority to FDA to oversee the safety of food, drugs, and cosmetics

Question 5

what is the nuremberg code and how did it come about?

Answer 5

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

Question 6

how did the willowbrook state school hepatitis study come about?

Answer 6

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.

Question 7

why was thalidomide withdrawn?

Answer 7

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

Question 8

what is the declaration of helsinki?

Answer 8

• 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

Question 9

what is the belmont report?

Answer 9

Prompted in part by Tuskegee Syphilis Study
3 fundamental ethical principles
◦ Respect for Persons
◦ Beneficence
◦ Justice

Question 10

what is ich?

Answer 10

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

Question 11

what is GCP?

Answer 11

• rules of conducting good, clean, ethical research.

- Originated in response to unethical, unsafe and abuse of human rights

Question 12

why must adhere to GCP?

Answer 12

• 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

Question 13

what is the purpose of GCPs?

Answer 13

• Make most efficient use of human, animal and
  material resources
• Improve public health - achieve earlier availability of
  new treatments

Question 14

what is QSEM in ICH?

Answer 14

Quality - Stability testing, GMP
Safety - toxicology testing, pharmacology studies
Efficacy - Safety Data Management, GCP
Multidisciplinary - medical terminologies

Question 15

what is in ICH?

Answer 15

8 chapters, 61 definitions and 13 high level statements based on declaration of helsinki

Question 16

what is GCP legislation?

Answer 16

• 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

Question 17

what is protocol?

Answer 17

A document that describes the objective(s), design,
methodology, statistical considerations, and
organization of a trial

Question 18

what is sponsor?

Answer 18

An individual, company, institution, or organization
which takes responsibility for the initiation,
management, and/or financing of a clinical trial

Question 19

what is CRO?

Answer 19

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

Question 20

what is CRA?

Answer 20

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).

Question 21

what is investigator?

Answer 21

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)

Question 22

what is a doctor and investigator?

Answer 22

doctor : A person trained in the healing arts and licensed to practice
investigator : One who searches diligently into a subject - physician, dentist, nutrionist

Question 23

what is subject?

Answer 23

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control

Question 24

what are RA?

Answer 24

bodies having the power to regulate

• review submitted clinical data and those that conduct inspections
• In SG : HSA

Question 25

what is IRB?

Answer 25

Institutional Review Board
- An independent body constituted of medical, scientific, and nonscientific members, whose responsibility is to ensure the protection of
the rights, safety and well-being of human subjects involved in a trial

Question 26

how does IRB ensure protection and well-being of subjects?

Answer 26

Reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects

Question 27

what does GCP need?

Answer 27

• Protect human participants in research ( ETHICAL )

- Regulate new drugs - include labelling ( QUALITY DATA )