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

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Do write to us through:• Email: crcs@nhg.com.sg• Snail mail:

Clinical Research Coordinator Society (CRCS)

c/o Research & Development Office

6 Commonwealth Lane

#04-01/02 GMTI Building

Singapore 149547