Issue: An error happened in giving a medication dosage to a trial participant/ subject.
The error happened due to a mistake by the pharmacy research technician in dispensing the correct dose of the investigational product. The pharmacy technician dispensed a dose that was for another patient who is not involved in the study. The research nurse gave the medication to the patient enrolled in the study, unaware of the pharmacy technician mistake. The event happened only in giving one dose. No adverse drug reaction happened. The event was discovered by the monitor during the trial site visit and documentation review.
Corrective and preventive action: Steps toward correcting and preventing such mistake from happening again has been taken. The preventative
The error happened due to a mistake by the pharmacy research technician in dispensing the correct dose of the investigational product. The pharmacy technician dispensed a dose that was for another patient who is not involved in the study. The research nurse gave the medication to the patient enrolled in the study, unaware of the pharmacy technician mistake. The event happened only in giving one dose. No adverse drug reaction happened. The event was discovered by the monitor during the trial site visit and documentation review.
Corrective and preventive action: Steps toward correcting and preventing such mistake from happening again has been taken. The preventative