Module 3: Quiz about Investigator

A trial involves payments to subjects for participation. How should this be handled in the informed consent process?

The amount should be approved by the Ethics Committee and included in the subject information.

The subjects should not be informed about the payment until after they have taken part.

The subjects should never be paid to take part in a clinical trial.

A subject wishes to withdraw from a trial. What should the investigator do?

Let the subject withdraw.

Persuade the subject to remain in the trial.

Let the subject withdraw and make a reasonable effort to ascertain the reason(s) for withdrawal, while fully respecting the subject's rights.

Can the study nurse make the final diagnosis of an adverse event and decide the treatment of it?

Yes

For double-blinded trial, is it allowed to break the treatment code for a subject; I.e. Identification of the investigational product is revealed?

Yes – only in case of a medical emergency where the knowledge of the investigational product is required for therapeutic decisions for the treatment of the subject.

Under which of the following circumstances would the investigational product need to be quarantined at the site?

The site staff are on holiday.

No subject visits are scheduled in the next month.

The product has been damaged during shipment.

Who should fully inform the subject about the clinical trial?

Ethics Committee

Sponsor

Investigator

The investigator or a person designated by the investigator

The study nurse found out that the data in the subject’s medical records was captured incorrectly. How should she make the correction?

Cross over the old data by one cross, write the correct data next to the old data. Date and initiale.

Use a white-out pen to cover the old data and enter the new data.

5 years after the trial completion, the investigator decides to destroy all documents related to the trial. Is it acceptable?

Yes

No, the investigator should not destroy any trial document without agreement with the sponsor.

According to ICH GCP when it is recommended that the investigator informs the subject’s primary physician about the subject’s participation in the trial?

If trial procedure will impact on existing medical care.

If the subject agrees to the primary physician being informed.

If the investigator deviated from the trial protocol to eliminate immediate hazards to the trial subjects, what should the investigator do afterwards?

Nothing

Document the deviation.

Document the deviation and report it promptly to the sponsor and IRB/IEC.

According to GCP, data reported on the case report form (CRF), that are derived from source document should be:

Consistent with the source documents.

Consistent with the source documents or the discrepancies should be explained.

Consistent with the source documents where possible.

Consistent with the source documents for primary endpoint and safety measures.

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