CRC Foundations - Sponsor
Responsibilities questions & actual
answers.
Define the sponsor responsibilities in a clinical investigation. ANS -
List the major areas of sponsor responsibilities ANS -
Explain the sponsor-investigator relationship. ANS -
Who Is the Sponsor? ANS -an individual, company, institution, or organization that takes responsibility
for the initiation, management, and/or financing of a clinical trial
What are the sponsor's regulatory responsibilities? ANS -
The sponsor of a clinical investigation is defined as:
A) An individual, company, institution, or organization that conducts a clinical trial
B) An individual, company, institution, or organization that takes responsibility for the initiation,
management, and/or financing of a clinical trial
C) An individual, company, institution, or organization that reviews the initiation, management, and/or
financing of a clinical trial ANS -An individual, company, institution, or organization that takes
responsibility for the initiation, management, and/or financing of a clinical trial
*The correct response is that a sponsor is an individual, company, institution, or organization that takes
responsibility for the initiation, management, and/or financing of a clinical trial. The sponsor does not
conduct the clinical trial, as that is the investigator. The sponsor does not review the initiation,
management, or financing.
In the event of a serious adverse event that is related to study participation and is unexpected, the
sponsor is required to:
Responsibilities questions & actual
answers.
Define the sponsor responsibilities in a clinical investigation. ANS -
List the major areas of sponsor responsibilities ANS -
Explain the sponsor-investigator relationship. ANS -
Who Is the Sponsor? ANS -an individual, company, institution, or organization that takes responsibility
for the initiation, management, and/or financing of a clinical trial
What are the sponsor's regulatory responsibilities? ANS -
The sponsor of a clinical investigation is defined as:
A) An individual, company, institution, or organization that conducts a clinical trial
B) An individual, company, institution, or organization that takes responsibility for the initiation,
management, and/or financing of a clinical trial
C) An individual, company, institution, or organization that reviews the initiation, management, and/or
financing of a clinical trial ANS -An individual, company, institution, or organization that takes
responsibility for the initiation, management, and/or financing of a clinical trial
*The correct response is that a sponsor is an individual, company, institution, or organization that takes
responsibility for the initiation, management, and/or financing of a clinical trial. The sponsor does not
conduct the clinical trial, as that is the investigator. The sponsor does not review the initiation,
management, or financing.
In the event of a serious adverse event that is related to study participation and is unexpected, the
sponsor is required to:
