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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13. Ongoing safety<br />
evaluation<br />
• Promptly notify – findings that may affect : -<br />
- the safety of subjects<br />
- impact the conduct of the trial<br />
- alter the IRB/EC approval to continue the trial.<br />
• For all ADR are both serious & unexpected,<br />
expedite reporting to: -<br />
- all investigators<br />
- Independent Review Board<br />
- Regulatory authorities.<br />
CRC GCP Workshop 2012 H<strong>UKM</strong>