Introduction to GCP (Good Clinical Practice) and Laws

Question 1

What is GCP?

Answer 1

Good Clinical Practice
the rules of conducting good, clean, ethical research
In response to unethical, unsafe and abuse of human rights

Question 2

What was the Tuskegee study about? What law did this lead to?

Answer 2

(1932-19772)

399 impoverished black men were recruited for the Syphilis study (A highly contagious sexually transmitted bacterial infection characterized by painless sore on the genitals, rectum or mouth).

Researchers failed to treat the patients appropriately after the 1940s validation of penicillin as an effective cure

This lead to (OHRP) Office for Human Research Protection and 1979 Belmont report

Question 3

What incident lead to the 1938 Federal Food, Drug and Cosmetic Act?

Answer 3

Sulfanilamide incident

Elixir Sulfanilamide was improperly prepared and caused mass poisoning in the US 1937, more than 100 deaths

Question 4

What is the Nuremberg code? What does it Emphasize?

Answer 4

A set of ethical principles for human experimentation
As a result of the subsequent Nuremberg trials at the end of world war 2

Emphasizes on:
1- Informed Consent
2-Absence of coercion (no persuasion)
3-Properly formulated scientific experimentation
4-Beneficence towards experiment participants

Question 5

What occurred at Willow brook state school for Hepatitis studies?

Answer 5

Healthy children were intentionally inoculated orally by injection with the hep A virus. They were monitored to gauge the effects of Gamma Globulin in combating it

Question 6

Give an example of a medical incident that occurred which lead to stricter testing for drugs:

Answer 6

Thalidomide, a sedative drug in late 1950s

Withdrawn from the market after being found to cause birth defects

Question 7

What is the declaration of Helsinki?

Answer 7

Developed by World Medical Association (WMA)
A set of ethical principles for the medical community

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 8

What are the 3 fundamental Ethical Principles in the Belmont Report?

Answer 8

1. Respect for Persons
2. Beneficence (resulting in good)
3. Justice

Question 9

What is the purpose of the initiation of ICH? (International Conference of Harmonisation)

Answer 9

1990s, brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan and the US

Question 10

Why is important to follow GCP?

Answer 10

With Adherence to GCP standards,

1. Ethics- Rights, integrity and confidentiality of research subjects are protected
2. Quality of data- credibility of data
3. Unified standard- provide a unified standard for the EU, Japan and US to facilitate mutual acceptance of clinical data by the RA

Question 11

Why harmonize GCPs? What are the goals to be achieved?

Answer 11

Standardize the conduct of clinical trials across world regions, so that clinical trial could be universally accepted

Goals:
1. Efficiency of resources: Make most efficient use of human, animal and material resources
2.Improve public health: Achieve earlier availability of new treatment (quicker approval)
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Question 12

What are the prime objectives of the GCP legislation?

Answer 12

1- To ensure that the trials of new products in humans are performed so as to ensure the least amount of harm to participants
2- To ensure that the safety and efficacy of the product is adequately demonstrated

Question 13

Define protocol:

Answer 13

A document that describes the
1-objective(s)
2-design
3-methodology
4-statistical considerations and 5- organization of a trial 

Also gives background and rationale for the trial but these could be provided in other protocol referenced documents

Question 14

What should the protocol involve?

Answer 14

A written, detailed action plan that:

1. Provides background about the trial
2. Specifies trial objectives
3. Describes trial’s design and organization
4. Ensures that trial procedures are standardized (e.g how to administer study drugs, visit intervals)
5. Defines adverse events and endpoints
6. Outlines data analysis plan

Question 15

Define a sponsor:

Answer 15

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

Question 16

What is a CRO?

Answer 16

Clinical Research Organization (CRO)

A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions

Question 17

What is a CRA? What are their responsibilities?

Answer 17

Clinical Research Associate-also known as monitor

Person employed by Sponsor/CRO to conduct monitoring

Responsibility is to monitor,

Monitoring:
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and report in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements

Question 18

Define Monitoring:

Answer 18

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, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements

Question 19

What is an investigator’s role?

Answer 19

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 principle investigator (PI)

remaining investigators are sub-investigator or co-investigators

Question 20

Define Subject/Trial subject:

Answer 20

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

Question 21

What is the role of Regulatory Authorities?

Answer 21

Bodies having the power to regulate

Includes authorities that review submitted clinical data and those that conduct inspections

In Singapore: HSA (health sciences authority)

Question 22

What is IRB?

Answer 22

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

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