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Quiz #1

1)	The FDA GLPs regulations became effective as a law in the US during what year?
		1976
		1978
		1979
		1980

2)	What do the FDA GLPs not regulate?
		Organization & Personnel
		Facilities
		Testing Facilities Operations
		Scientific Process

3)	In a multisite study,
		The PI is the Private Investigator.
		The PI writes their own protocol.
		The test facility's Master Schedule only contains activities conducted at the test facility.
		The Study Director approves and issue amendments relating to work undertaken at other sites

4)	According to the FDA GLPs, who is responsible to ensure that the study is conducted according to GLPs?
		Study Coordinator
		Study Manager
		Study Director
		Training Coordinator

5)	What is not required to be in the personnel file?
		Curriculum vitae
		Training records
		Job descriptions
		Job application

6)	Test Facility Management
		Needs to sign off on SOPs to signify that they agree with and support the SOP
		Don't need to review the SOP since others already reviewed it
		Must have Quality Assurance review and approve the SOP before it can be finalized
		May authorize the Study Director to sign an SOP in their place

7)	Data may be documented after all activities are completed for the day, as long as the person who performs the procedure ensures that data DO get recorded on the day the procedure occurs.
		OK as long as this is documented in an SOP
		Not acceptable, as data needs to be recorded promptly
		Not accpetable, unless authorized by the Study Director
		OK but it must go to Test Facility Management for approval

8)	The FDA GLPs define the role of a Study Coordinator.
		TRUE
		FALSE

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