Chicken Soup for the Busy Coordinator Dearest colleagues, friends and members of the Clinical Research Coordinator Society, Welcome to the launch of the “Chicken Soup for the Busy Coordinator” series! The Society understands that the multitasking coordinator faces a multitude of ambiguous problems and tricky situations and aims to be a resource avenue for these professionals. As the name implies, the objective of this series of correspondences is to nourish our busy coordinators with essential, useful and practical knowledge that is easy to understand and apply in the typical research environment. We hope that you would benefit from the regular information blasts and look forward to your feedback and suggestions to help us improve further! Looking forward to hearing from you! Yours Sincerely, Belinda Mak Chairperson Clinical Research Coordinator Society

Chicken Soup for the Busy Coordinator January 2009

Tip of the Month Scenario: My subject signed the consent form to be enrolled in our study and I gave him a photocopy of the signed and dated consent form. Is that all that is required by the regulations for the consent process?

NO. The subject's signature on the consent form provides documentation of agreement to participate in a study, but is only one part of the consent process. To be effective, the process should provide ample opportunity for the investigator and the subject to exchange information and ask questions. Answer

Please refer to the regulations: SGGCP 4.8 Informed Consent of Trial Subjects. 21 CFR 50 Protection of Human Subjects Subpart B - Informed Consent of Human Subjects. ICH Guideline for Good Clinical Practice 4.8 Informed Consent of Trial Subjects. References

Your feedback is important to us. Feel free to write to us through: Snail mail: Clinical Research Coordinator Society (CRCS) c/o Research & Development Office 6 Commonwealth Lane #04-01/02 GMTI Building Singapore For more information