L35 Clinical Trials LA

Question 1

What 3 individuals are involved in clinical trials

Answer 1

Chief Investigator
Co investigator
Qualified Person

Question 2

What is an investigational Medicinal Product

Answer 2

Anything being tested falls under this category: API/Placebo/Comparator

Question 3

Role of chief investigator?

Answer 3

primary responsible person overseeing all clinical trial sites and staff.

Question 4

What is Good clinical practice and what is it for?

Answer 4

Overview
- A set of internationally recognised ethical and scientific quality requirements for conducting clinical trials
Principles: REMPIB
- Rights, safety, and well-being of subjects should prevail over interests of the study
- Each QP involved in the clinical trial should be appropriately qualified
- Medical care by healthcare practitioner
- Informed consent
- Patient Confidentiality
- Benefits justify risk

• CT conducted ethically and follow regulatory requirements

Question 5

outline GMP

Answer 5

Good Manufacturing Practice is a process in which MP and IMPs are manufactured according to the quality standards appropriate to their intended use as required by the product specification

Question 6

what does informed consent ensure

Answer 6

• subject’s voluntary participation and freedom to withdraw
• subject’s understanding and permission to undergo the trial
• Ensure subject’s understanding of risks
• Ensure confidentiality of subject’s identity
• Ensure proper remuneration and medical treatment for subject
• Ensure all relevant information is made available to subject

Question 7

what does Ethical considerations mean?

Answer 7

• Involves fairness, doing good, doing no harm, and respecting individual rights
• Considers risk and benefits

Question 8

All clinical trials involving IMPs need a particular type of authorisation. What is it called?

Answer 8

A clinical Trial Authorisation.
Review for phase 1: 14-21 days
Review for phase 2: up to 60 days

Question 9

What is the IMP dossier?

Answer 9

summary of:
- Quantitiy
- Manufacture
- Control
of all IMPs. Also contains non clinical + toxicology studies, and thus risk/benefit of the drug overall.

Question 10

Outline the role of the research ethics committees

Answer 10

two types:

Type 1: review phase one clinical trial IMPs in healthy volunteers.

Type 3: review of clinical trials IMP in healthy volunteers in 2,3,4 of clinical trials, and all other reseach taking place in more than one domain in UK.