Module 7: Quiz about Handling of Investigational Medicinal Products (IMP)

Who trains the investigator and site staff in handling of the investigational medicinal products (IMP)?

Sponsor

Regulatory Authority

IEC/IRB

Who should instruct the subject about the correct use, storage and return of the IMP to the site?

Sponsor

Investigator or delegated site staff

IEC/IRB

Regulatory Authority

Who has the main responsibility for performing drug accountability?

Sponsor

Investigator or delegated site staff

What is the purpose of drug accountability?

To document which investigational product has been dispensed to subjects and returned by them. Drug accountability result is to measure the subject’s compliance with the investigational product.

To demonstrate that investigational product has been stored appropriately.

To allow appropriate dispensing of investigational product.

All hospital staff has access to investigational medicinal product (IMP)?

Yes

No - only authorised staff.

Can unused investigational medicinal product (IMP) be stored with used IMP?

Yes

Who should ensure that the investigational medicinal products (IMP) are stable over the period of use?

Sponsor

Investigator

Regulatory authority

IEC/IRB

When the investigational medicinal product is delivered with a temperature during shipment outside the allowed temperature ranges. What should the site staff do?

Make an evaluation of the temperature and release the product.

Report the case to the sponsor immediately and await sponsor's instruction.

Who needs to keep the samples of the IMP after the end of a clinical trial?

The sponsor

The investigator

Regulatory Authority

Who has responsibility for IMP once it is at the site?

The sponsor

The investigator

Regulatory Authority

The investigator or delegated by the investigator should maintain records of which of the following:

Product’s delivery to the site

The inventory at the site

The use of each subject

The return to the sponsor or alternative disposition of unused products.

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Module 7: Quiz about Handling of Investigational Medicinal Products (IMP)

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