CCRC - Certified Clinical Research Coordinator Informed Consent Process Questions and Answers

Question 1

A potential participant in a clinical trial is fully fluent in Spanish but has limited English proficiency.
The IRB-approved informed consent form (ICF) is only available in English.
Which of the following is the most appropriate action for the Clinical Research Coordinator (CRC) to take?

Accepted Answer

Inform the participant they cannot be enrolled until an official, IRB-approved Spanish translation of the ICF is available.

Answer

Use a qualified, impartial interpreter to translate the English ICF to the participant during the consent discussion and document the process thoroughly.

Answer

Proceed with the consent process using the English ICF and have a bilingual site staff member informally translate key sections.

Answer

Provide the participant with the English ICF and ask them to use a consumer translation app on their phone for understanding.

Question 2

Which of the following is a primary responsibility of the CRC during the informed consent process?

Accepted Answer

Assessing the potential participant's understanding of the study information provided.

Answer

Determining the participant's medical eligibility for the study.

Answer

Ensuring the investigator has signed the ICF before the participant.

Answer

Deciding on the compensation amount for study participation.

Question 3

A participant has been enrolled in a long-term oncology trial for two years. The sponsor issues a protocol amendment that introduces a new, optional sub-study involving additional blood draws to test for a novel biomarker. What is the CRC's responsibility regarding the informed consent for this change?

Accepted Answer

Ensure the participant is re-consented using a new, IRB-approved consent form that details the optional sub-study.

Answer

Obtain verbal consent from the participant for the sub-study and document it in the progress notes.

Answer

No action is needed as the main study consent covers minor additions.

Answer

Inform the participant of the new sub-study during their next visit without requiring a signature.

Question 4

According to federal regulations (45 CFR 46 and 21 CFR 50), the informed consent process must minimize the possibility of coercion or undue influence. Which scenario best exemplifies undue influence?

Accepted Answer

An investigator offers an excessively large monetary payment to a financially vulnerable individual to encourage enrollment in a high-risk study.

Answer

A CRC offers a potential participant an IRB-approved compensation of $50 for each study visit to cover time and travel.

Answer

An investigator tells their own patient that their access to standard medical care will be limited if they do not enroll in the clinical trial.

Answer

A CRC provides a potential participant with a thorough explanation of the study in a private, quiet room.

Question 5

During an informed consent discussion for a pediatric study, the CRC must obtain permission from the parents/legal guardian. What additional step is typically required for the pediatric participant?

Accepted Answer

Obtaining the child's assent using an age-appropriate form and discussion.

Answer

Having the child sign the full informed consent form.

Answer

Documenting the child's verbal agreement in the source documents.

Answer

No additional step is needed if the parents provide consent.

Question 6

An investigator delegates the task of obtaining informed consent to the CRC. The consent form is signed and dated by the participant and the CRC. Later, a monitor reviewing the study files notes an error. Which of the following represents a common and significant documentation error in the informed consent process?

Accepted Answer

The version of the consent form used was outdated and had been superseded by a more recent IRB-approved version.

Answer

The participant was given a copy of the signed consent form to take home.

Answer

The consent discussion took place in a private examination room.

Answer

The CRC who obtained consent was listed on the delegation of authority log for that task.