GCP - UKM Medical Centre - Universiti Kebangsaan Malaysia

Mitchell Creinin from Pittsburgh:
Trial on a medical device
Inform Subject
“…informed consent document…does not identify
foreseeable risks…”
Notify IRB
“…failed to submit the sponsor’s model consent form … to
the Magee-Womens Hospital IRB…”
Adhere to Protocol
“…log forms were not completed…in specific dates.”
Report Adverse Events
“irritation or discomfort…was not recorded on …case report
forms.”
Maintain Records
“You did not maintain complete records related to
each…case history.”