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Chicken Soup for the Busy Coordinator May 2009

Chicken Soup for the Busy Coordinator May 2009. Tip of the Month. Case Scenario: I have a new clinical trial agreement that is in the process of negotiation. For ethical reasons and safety of the subjects, insurance and indemnity will have to be provided for this study.

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Chicken Soup for the Busy Coordinator May 2009

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  1. Chicken Soup for the Busy CoordinatorMay 2009

  2. Tip of the Month Case Scenario: • I have a new clinical trial agreement that is in the process of negotiation. • For ethical reasons and safety of the subjects, insurance and indemnity will have to be provided for this study. • Who should be the one providing insurance coverage and indemnity for this study?

  3. Answer • The party to provide the insurance coverage and indemnity for the clinical trial, will be based on the type of trial being conducted: • For an Industry Sponsored Trial, insurance and indemnity will be provided by the Company sponsoring the trial. • For the Principal Investigator initiated Trial, insurance will be provided by the institution that undertakes the trial. The provider of the study material will provide the indemnity for the product that is used in the clinical trial. (Exception is when study material are commercially available, and given according to labeled use and dosage.) • The certificate of insurance is to be provided by the Sponsor/ Clinical Research Administration office of the institution.

  4. References • Clinical Trial Agreement (CTA) • Clause on “Indemnity” • Clause on “Insurance” • PCR SOP 501-B02 • PCR 599-001 NHG CTA Guidelines • PCR 504-001 NHG CTA Checklist • PCR 507-001 NHG CTA Template • SGGCP 5.8, 8.2.4, 8.2.5, 8.2.6

  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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