Transcript Chicken Soup for the Busy Coordinator

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” email 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?
Answer
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.
References
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.
For more information
• Your feedback is important to us. Feel
free to write to us through:
• Email: [email protected]
• Snail mail:
Clinical Research Coordinator Society (CRCS)
c/o Research & Development Office
6 Commonwealth Lane
#04-01/02 GMTI Building
Singapore 149547