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

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

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

Monitoring frequency depends on the trial complexity, subject population and number, and site staff experience.

Yes

Can the sponsor perform audit at trial site before the trial is initiated?

Yes

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Module 4: Quiz about Sponsor

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