Chicken Soup for the Busy Coordinator April 2009
Tip of the Month Scenario: When may the pharmaceutical company sponsored study be initiated?
The study should be initiated only when the following are available: 1.IRB/ DSRB approval. 2.HSA approval & (Applicable to therapeutic studies). 3. Clinical Trial Agreement or Contract that has been signed by the sponsor, PI and the institution representative. Answer
References SGGCP 3, DSRB Investigator Manual download from DSRB website: HSA website:
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