ROLES OF THE SPONSOR - UKM Medical Centre
ROLES OF THE SPONSOR - UKM Medical Centre
ROLES OF THE SPONSOR - UKM Medical Centre
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9. IRB/EC approval<br />
• Confirm/ Obtain from the investigator the<br />
IRB/EC approval<br />
• Ensure completeness of approval Letter : –<br />
- Protocol Title, version date<br />
- Statement of what was reviewed & approved<br />
e.g. Informed Consent – version date<br />
subject’s transport allowance<br />
advertisement<br />
- GCP statement QC<br />
- EC members list<br />
CRC GCP Workshop 2012 H<strong>UKM</strong>