Quality Management 2017

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

50 Gy

70Gy

60Gy

70Gy

requirement

Deviation definition

<44 Gy to any part of PTV1

<66.5 Gy

D90<57 Gy

<66.5Gy to any part of GTV

Or

D10>70 Gy

Tolerance

Lower limit

Upper and lower limit

Lower limit

Lower limit

-6 Gy

Dose per fraction 2 Gy. If other re-scale doses to Biological Equivalent doses