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Chicken Soup for the Busy Coordinator

Chicken Soup for the Busy Coordinator. April 2009. Tip of the Month. Scenario: When may the pharmaceutical company sponsored study be initiated?. Answer. The study should be initiated only when the following are available: IRB/ DSRB approval. HSA approval &

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Chicken Soup for the Busy Coordinator

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  1. Chicken Soup for the Busy Coordinator April 2009

  2. Tip of the Month Scenario: • When may the pharmaceutical company sponsored study be initiated?

  3. Answer The study should be initiated only when the following are available: • IRB/ DSRB approval. • HSA approval & (Applicable to therapeutic studies). 3. Clinical Trial Agreement or Contract that has been signed by the sponsor, PI and the institution representative.

  4. References • SGGCP 3, 4.4.1 • DSRB Investigator Manual download from DSRB website: www.b2bresearch.nhg.com.sg • HSA website: www.hsa.gov.sg

  5. Feedback Your feedback is important to us. 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

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