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. 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

4. References  SGGCP 3, 4.4.1  DSRB Investigator Manual download from DSRB website: www.b2bresearch.nhg.com.sg 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