Module 4: Quiz about Sponsor

Which of the following is defined as sponsor according GCP?
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
A company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
Which of following are correct in clinical trial conduct?
Adequate resources and facility
Well-trained staff
Verbal delegation of tasks
Keeping timelines is the most important consideration
Which of following tasks should be performed by the monitor during monitoring visit?
Source data verification
Drug accountability and handling
Verifying protocol compliance by the investigator/site staff
Verifying informed consents
Checking delegation, equipment and facility
In a double-blinded (DB) trial, the sponsor can unbreak the blinding of the treatment:
Yes
No
yes, only in case of a suspected unexpected serious adverse reaction (SUSAR) by the sponsor staff handling adverse events.
The sponsor should notify promptly the findings and risks that could affect adversely the safety of subjects or impact on the conduct of the trial (e.g. new observations on the investigational product, particularly with respect to adverse reactions, risk and safe use) to:
The local regulatory authority
IEC/IRB
It is the responsibility of the sponsor to write the protocol.
Yes
No
What is a case report form (CRF)?
Forms designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
Instruction on handling of adverse event.
Report of each subject’s health status.
Who designs the Case Report Form (CRF)?
Sponsor
Investigator
Regulatory Authority
The monitor has access to medical records generated by investigator/trial site in order to perform source data verification (SDV)?
Yes
No
Monitoring frequency depends on the trial complexity, subject population and number, and site staff experience.
Yes
No
Who should perform audit?
Investigator
Sponsor
Regulatory authority
Can the sponsor perform audit at trial site before the trial is initiated?
Yes
No
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