Chicken Soup for the Busy Coordinator October 2009

You are conducting a Randomized, Open-Label, 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?

Tip of the Month: Recruitment Issues

Case Scenario:

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 MakResearch Nurse ManagerGastro Clinical TrialNational 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

• 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 Office6 Commonwealth Lane#04-01/02 GMTI BuildingSingapore 149547

For More Information