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 PCR SOP 501-C01 ICH Guideline for Good Clinical Practice 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

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