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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
No
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.
Is it allowed to discard the shipping records after receipt?
Yes
No
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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