tr CRFs

Example Case Report Forms for TR domain

Form: New Lesion

Question	Response
Lesion Number	NL01 NL02 NL03 NL04 NL05 NL06 NL07 NL08 NL09 NL10 NL11 NL12 NL13 NL14 NL15 NL16 NL17 NL18 NL19 NL20 TU.TULNKID
Date of Assessment	TU.TUDTC
Anatomical Location	Adrenal Gland Arm Axilla Brain Bladder Bone Breast Buttock Ear Other TU.TULOC
Anatomical Location Other Specify	SUPPTU.TULOCOTH
Laterality	Left Right TU.TULAT
Directionality	Anterior Posterior Deep Distal Inferior TU.TUDIR
Method of Evaluation	X-Ray CT Scan MRI PET TU.TUMETHOD
Status	Complete Response (CR) Non-CR/Non-PD Progressive Disease (PD) Not Evaluable (NE) RS.RSORRES

Form: Non-target Lesion

Question	Response
Lesion Number	NTL01 NTL02 NTL03 NTL04 NTL05 NTL06 NTL07 NTL08 NTL09 NTL10 NTL11 NTL12 NTL13 NTL14 NTL15 NTL16 NTL17 NTL18 NTL19 NTL20 TU.TULNKID
Date of Assessment	TU.TUDTC
Anatomical Location	Adrenal Gland Arm Axilla Brain Bladder Bone Breast Buttock Ear Other TU.TULOC
Anatomical Location Other Specify	SUPPTU.TULOCOTH
Laterality	Left Right TU.TULAT
Directionality	Anterior Posterior Deep Distal Inferior TU.TUDIR
Method of Evaluation	X-Ray CT Scan MRI PET TU.TUMETHOD
Status	Complete Response (CR) Non-CR/Non-PD Progressive Disease (PD) Not Evaluable (NE) RS.RSORRES

Form: Target Lesion

Question	Response
Lesion Number	TL01 TL02 TL03 TL04 TL05 TU.TULNKID
Date of Assessment	TU.TUDTC
Anatomical Location	Adrenal Gland Arm Axilla Brain Bladder Bone Breast Buttock Ear Other TU.TULOC
Anatomical Location Other Specify	SUPPTU.TULOCOTH
Laterality	Left Right TU.TULAT
Directionality	Anterior Posterior Deep Distal Inferior TU.TUDIR
Method of Evaluation	X-Ray CT Scan MRI PET TU.TUMETHOD
What was the Diameter of the Tumo	TU.TUORRES
What were the units for the Diame	mm cm TU.TUORRESU
Reason not measured	Coalesce Split Too small to measure Not Evaluable
If Not Evaluable (NE), select	Cavitation Necrosis Fibrosis Poor Scan Quality Other
Sum of Target Lesion Diameters