GCP - UKM Medical Centre - Universiti Kebangsaan Malaysia

Michael Gruber from NYU:
Trial using biologics
Maintain Records
“…failed to prepare and maintain…accurate case
histories…” AND “…lack of source data…”
Retain Records
“…failed to retain investigational records.”
Adhere to Protocol
“…there were many deviations from the protocol
requirements…”
Supervise
“…nurse practitioner was not listed on the Form FDA-
1572 as subinvestigator,…”