QUESTION: 25

A clinical study of a drug is completed to support a marketing approval application. According to ICH, how long should a sponsor retain the clinical study essential documents?

For at least two years after the last approval of an application in an ICH region
For a minimum of 10 years after completion of the clinical study
Three years after the last clinical study site was supplied with investigational drugs
Until the product has been discontinued from marketing in all ICH regions

Answer(s): A

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QUESTION: 26

A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

Documented agreement
Frequent communication
Early collaboration
Follow-up meeting after submission

Answer(s): B

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During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.

Which action is MOST appropriate for the regulatory affairs professional to take?

Allow the auditor access to the room and records due to the current audit.
Allow the auditor accompanied access to the room to retrieve the records.
Deny the auditor access to the room and retrieve only the requested records.
Deny the auditor access to the room and records due to confidentiality concerns.

Answer(s): B

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QUESTION: 28

According to ICH, which of the following components of study information is NOT required in a clinical study report?

Randomization scheme and codes
Protocol and protocol amendments
List of lECs or lRBs
Detailed CV of all investigators

Answer(s): D

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QUESTION: 25

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QUESTION: 27

QUESTION: 28