SOCRA CCRP Informed Consent 2

Question 1

Under ICH-GCP, which of the following must be included in the informed consent form?

Accepted Answer

A statement that participation is voluntary and that the subject may withdraw at any time without penalty

Answer

The sponsor's total budget for the trial

Answer

The names of all other participants in the study

Answer

A guarantee of therapeutic benefit

Question 2

What must occur before any trial-related procedures are performed on a potential study subject?

Accepted Answer

Written informed consent must be obtained

Answer

The subject must complete all screening assessments

Answer

The subject must receive the investigational product

Answer

The site must submit the first enrollment report

Question 3

How should the informed consent process be handled for a subject who cannot read?

Accepted Answer

An impartial witness must be present during the entire consent discussion and must sign the consent form

Answer

The subject cannot participate in clinical trials

Answer

The investigator may waive the consent requirement

Answer

A family member can sign without the subject's involvement

Question 4

When a significant new finding arises during a clinical trial that could affect a subject's willingness to continue, what action is required?

Accepted Answer

The subject must be informed promptly and re-consent must be obtained with a revised consent form

Answer

No action is needed until the trial ends

Answer

The finding should be reported only to the sponsor

Answer

Only new subjects need to be informed

Question 5

What is the role of a legally acceptable representative (LAR) in the informed consent process?

Accepted Answer

To provide informed consent on behalf of a subject who is unable to provide consent themselves

Answer

To replace the subject entirely in making treatment decisions

Answer

To serve as the study monitor

Answer

To verify the accuracy of the case report forms

Question 6

Which of the following statements about informed consent language is correct according to ICH-GCP?

Accepted Answer

The consent form should be written in language that is understandable to the subject or the subject's legally acceptable representative

Answer

Technical medical terminology should be used to demonstrate scientific rigor

Answer

Legal disclaimers must be prominently featured

Answer

The consent form should be available only in English for standardization