Transcript Chicken Soup for the Busy Coordinator

Chicken Soup for the Busy
Coordinator
October 2009
Tip of the Month:
Recruitment Issues
Case Scenario:
You are conducting a Randomized, OpenLabel, Observational Study of Drug A
compared to the Standard of Care
treatment, with a ratio of 1:1.
A patient is very keen to participate in this
trial but insists on receiving Drug A.
What should you do?
Answer:
•
Ensure that the patient is fully informed before
deciding to participate in the trial
•
Explain that the trial uses randomization to allocate
treatment
•
Randomization is like flipping a coin and the patient
will have a 50% chance of receiving Drug A in the
study
•
If patient still insists on receiving Drug A, he/she is
not ready for the trial.
•
Do Not enroll patient into the trial
References:
• SG-GCP 4.8.10
• PCR SOP 501-C01
• ICH Guideline for Good Clinical Practice
4.8.10
• 21 CFR 50 Protection of Human Subjects
Subpart B - Informed Consent of Human
Subjects
Contributed By:
Belinda Mak
Research Nurse Manager
Gastro Clinical Trial
National University Hospital
Chicken Soup for the Busy
Coordinator Evaluation Survey
Dear DSRB/CRCS members,
We would like to invite you to take part in an Evaluation Survey on the
efficiency and applicability of the “Chicken Soup for the Busy
Coordinator” series.
We encourage you to provide feedback on how this series can benefit you
better.
Please access the survey via this link:
http://www.surveymonkey.com/s.aspx?sm=2XQWZBy2TiNkbzt_2fhOutEQ_3d_3d
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