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Quiz #1
The FDA GLPs regulations became effective as a law in the US during what year?
What do the FDA GLPs not regulate?
Organization & Personnel
Testing Facilities Operations
Scientific Process
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
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
What is not required to be in the personnel file?
Curriculum vitae
Training records
Job descriptions
Job application
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
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
The FDA GLPs define the role of a Study Coordinator.
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