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DEVIATIONS FROM PROCESSES: protocol
perfomance
Example: clinical trial
EFC 5512: RT QA documentation an
Operation Resource Manual (QART)
Definitions of significant deviations in protocol performance
Dose delivered:
Treated Volume
PTV1
PTV2
PTV3
GTV
Protocol
requirement
50 Gy
70Gy
60Gy
70Gy
Deviation definition
<44 Gy to any part
of PTV1
<66.5 Gy
Or
D10>70 Gy
D90<57 Gy
<66.5Gy to any part
of GTV
Tolerance
Lower limit
-6 Gy
Upper and
lower limit
Lower limit
Lower limit
Dose per fraction 2 Gy. If other re-scale doses to Biological
Equivalent doses