TRIAL ACTIVITIES II

Question 1

three conditions to be satisfied when considering informed consent?

Answer 1

• individual’s decision is voluntarily
• decision is made with an appropriate understanding of the circumstances
• patient’s choice is deliberate insofar as the patient has carefully considered all of the expected benefits, burdens, risks and have considered reasonable alternatives

Question 2

what is IP?

Answer 2

a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a CT.
- includes a product with a marketing authorisation when used/assembled in a way different from the approved form or when used for an unapproved indication/when used to gain further info about an approved use

Question 3

what is the sponsor’s responsibilities in managing IP according to GCP?

Answer 3

GCP requires that sponsors control access to the IP and also document the quantities produced, to whom the product is shipped and the disposition of any unused supplies

Question 4

state the purpose of study monitoring?

Answer 4

verify that :

• the rights and well-being of human subjects are protected
• reported that data are accurate, complete and verifiable from source documents
• conduct of the trial is in compliance with the currently approved protocol/amendments with GCP and with the applicable regulatory requirements

Question 5

describe 5 types of information that can be found in a CT report?

Answer 5

CT report is submitted to the EC and RA

• a summary of the study objectives
• a description of the overall study design and plan
• a description of any protocol amendments
• a description of the ethical aspects of the study
• a description of the administrative structure of the study

Question 6

what is monitoring?

Answer 6

the act of overseeing the progress of a CT and ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP and the applicable regulatory requirements