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Chicken Soup for the Busy Coordinator

Chicken Soup for the Busy Coordinator. March 2009. Tip of the Month. Question: Who should I list in the consent document as the contact person for subjects to pose questions to? . Answer.

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Chicken Soup for the Busy Coordinator

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  1. Chicken Soup for the Busy Coordinator March 2009

  2. Tip of the Month Question: • Who should I list in the consent document as the contact person for subjects to pose questions to?

  3. Answer 1. Many investigators list themselves, a Co-PI, or CRC as the contact for information regarding the study or trial-related injury. 2. It is good practice to list the approving Ethics Committee (EC) as the contact for questions related to the rights of trial subjects as the EC is viewed as a neutral entity to the study.

  4. References Please refer to the regulations: • SGGCP 4.8.10 • 21 CFR 50.25 (7) • ICH 4.8.10 (q)

  5. For more information • Your feedback is important to us. Feel free to 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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