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Chicken Soup for the Busy CoordinatorApril 2009
Tip of the MonthTip 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.
AnswerAnswer
ReferencesReferences
SGGCP 3, 4.4.1 DSRB Investigator Manual download from
DSRB website: www.b2bresearch.nhg.com.sg
HSA website: www.hsa.gov.sg
FeedbackFeedbackYour feedback is important to us.
Do write to us through:• Email: [email protected]• Snail mail:
Clinical Research Coordinator Society (CRCS)
c/o Research & Development Office
6 Commonwealth Lane
#04-01/02 GMTI Building
Singapore 149547