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A professional regulatory consultant reviewing clinical trial documents in an office setting, with charts and regulatory guidelines in the background, looking focused and engaged.

RAd Clinical Trial Knowledge Quiz

Test your knowledge on the regulatory aspects of clinical trials with our comprehensive quiz! This quiz is designed for professionals involved in clinical research and regulatory submissions, covering important topics like application procedures and document requirements.

Get ready to evaluate your understanding through multiple choice questions that will challenge your expertise:

Initial clinical trial applications
Import licenses and necessary documentation
Turnaround times and approvals

10 Questions2 MinutesCreated by ExploringRegulation357

The turnaround time for initial clinical trial application is 30 days

True

False

Import license application for ancillary items is to be submitted together with initial clinical trial application

True

False

Packing list is required for import license application of all items

True

False

Who should be the signatory for appendices and cover letters submitted to PFDA?

Global Site Activation Manager

Regulatory Advisor

Country Site Activation Specialist

Appendix D1 - Amendment application form is required for Amendment - Notification submission.

True

False

Update in patient materials requires prior approval from PFDA

True

False

Change in shelf-life of the investigational product requires submission of the following appendices EXCEPT:

Appendix D1

Appendix C4

Appendix C5

None of the above

What is the turnaround time for RAd QC review?

3 days

1 day

5 days

CSA shall save all the documents in Common drive > _REGULATORY SUBMISSIONS

True

False

Sites which are not Level 3 PHREB accredited is acceptable, provided that a Level 3 accredited site who will oversight will be identified.

True

False

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RAd Clinical Trial Knowledge Quiz

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