myCSG © |Area: SDTM| Concept: TU : Tumor/Lesion Identification | Lesson: L101 : Tumor/Lesion Identification |
Example to show the creation of SDTM.TU domain
Lesson description will be added soon
Lesson description will be added soon
:
| Question | Response |
|---|
TUYN : Tumor Assessment YN?
| Question | Response |
|---|---|
| Were target tumors identified? [TARG_TUYN] |
Yes No |
| Were non-target tumors identified? [NONTARG_TUYN] |
Yes No |
TUTGSC : Tumor Assessment - Target - Screening (RECIST v1.1)
| Question | Response |
|---|---|
| Line Number [TUSPID] |
|
| Tumor ID [TULNKID] |
T01 T02 T03 T04 T05 |
| Location [TULOC] |
ADRENAL GLAND BONE BRAIN CHEST COLON HEAD KIDNEY LIVER LUNG LYMPH NODE MEDIASTINUM NECK OMENTUM OVARY PANCREAS PELVIS PERITONEUM PLEURA RECTUM SKIN SOFT TISSUE SPINAL CORD SPLEEN STOMACH TESTIS THYROID GLAND TRACHEA UTERUS OTHER |
| If Other, Specify [OTHER_TULOC] |
|
| Method of Evaluation [TUMETHOD] |
|
| If Other, Specify [OTHER_TUMETHOD] |
|
| Date of Procedure [TUDAT] |
|
| Evaluator [TUEVAL] |
INVESTIGATOR INDEPENDENT ASSESSOR - RADIOLOGIST INDEPENDENT ASSESSOR - ONCOLOGIST |
| Longest Diameter [LDIAM_TRORRES] |
|
| Longest Diameter Unit [LDIAM_TRORRESU] |
mm |
| Shortest Diameter [SDIAM_TRORRES] |
|
| Shortest Diameter Unit [SDIAM_TRORRESU] |
mm |
TUTG : Tumor Assessment - Target (RECIST v1.1)
| Question | Response |
|---|---|
| Line Number [TUSPID] |
|
| Tumor ID [TULNKID] |
T01 T02 T03 T04 T05 |
| Location [TULOC] |
|
| If Other, Specify [OTHER_TULOC] |
|
| Select if changes to tumor were identified [TUCHANGE] |
|
| Method of Evaluation [TUMETHOD] |
|
| If Other, Specify [OTHER_TUMETHOD] |
|
| Date of Procedure [TUDAT] |
|
| Tumor Identification Evaluator [TUEVAL] |
INVESTIGATOR INDEPENDENT ASSESSOR - RADIOLOGIST INDEPENDENT ASSESSOR - ONCOLOGIST |
| Longest Diameter [LDIAM_TRORRES] |
|
| Longest Diameter Unit [LDIAM_TRORRESU] |
mm |
| Check if the diameter was too small to measure [TRTOOSM] |
|
| Check if the tumor was inevaluable [TRINEVAL] |
|
| If the tumor was inevaluable, what was the reason? [TRREASND] |
|
| Shortest Diameter [SDIAM_TRORRES] |
|
| Shortest Diameter Unit [SDIAM_TRORRESU] |
mm |
TUNT : Tumor Assessment - Non-Target (RECIST v1.1)
| Question | Response |
|---|---|
| Line Number [TUSPID] |
|
| Tumor ID [TULNKID] |
NT01 NT02 NT03 NT04 NT05 NT06 NT07 NT08 NT09 NT10 NT11 NT12 NT13 NT14 NT15 NT16 NT17 NT18 NT19 NT20 |
| Location [TULOC] |
ADRENAL GLAND BONE BRAIN CHEST COLON HEAD KIDNEY LIVER LUNG LYMPH NODE MEDIASTINUM NECK OMENTUM OVARY PANCREAS PELVIS PERITONEUM PLEURA RECTUM SKIN SOFT TISSUE SPINAL CORD SPLEEN STOMACH TESTIS THYROID GLAND TRACHEA UTERUS OTHER |
| If Other, Specify [OTHER_TULOC] |
|
| Select if changes to tumor were identified [TUCHANGE] |
Tumor Split Tumor Merged |
| Method of Evaluation [TUMETHOD] |
CLINICAL EVALUATION CT SCAN ENDOSCOPY MRI PET SCAN PET/CT SCAN PET/MRI SCAN PHOTOGRAPHY PHYSICAL EXAMINATION SCINTIGRAPHY SPIRAL CT ULTRASOUND X-RAY OTHER |
| If Other, Specify [OTHER_TUMETHOD] |
|
| Date of Procedure [TUDAT] |
|
| Evaluator [TUEVAL] |
INVESTIGATOR INDEPENDENT ASSESSOR - RADIOLOGIST INDEPENDENT ASSESSOR - ONCOLOGIST |
| Tumor State [TUMSTATE_TRORRES] |
Present Absent |
| Check if the tumor was inevaluable [TRINEVAL] |
Inevaluable |
| If the tumor was inevaluable, what was the reason? [TRREASND] |
Lesion or Background Change that Prevents Evaluation Focal Intervention Poor Scan Quality Insufficient Images/Anatomy Inconsistent Modality Site Error |
TUNTSC : Tumor Assessment - Non-Target - Screening (RECIST v1.1)
| Question | Response |
|---|---|
| Line Number [TUSPID] |
|
| Tumor ID [TULNKID] |
|
| Location [TULOC] |
|
| If Other, Specify [OTHER_TULOC] |
|
| Method of Evaluation [TUMETHOD] |
|
| If Other, Specify [OTHER_TUMETHOD] |
|
| Date of Procedure [TUDAT] |
|
| Evaluator [TUEVAL] |
|
TUNW : Tumor Assessment - New (RECIST v1.1)
| Question | Response |
|---|---|
| Line Number [TUSPID] |
|
| Tumor ID [TULNKID] |
New Target 1 New Target 2 New Target 3 New Target 4 New Target 5 New Non-Target 1 New Non-Target 2 New Non-Target 3 New Non-Target 4 New Non-Target 5 |
| Location [TULOC] |
ADRENAL GLAND BONE BRAIN CHEST COLON HEAD KIDNEY LIVER LUNG LYMPH NODE MEDIASTINUM NECK OMENTUM OVARY PANCREAS PELVIS PERITONEUM PLEURA RECTUM SKIN SOFT TISSUE SPINAL CORD SPLEEN STOMACH TESTIS THYROID GLAND TRACHEA UTERUS OTHER |
| If Other, Specify [OTHER_TULOC] |
|
| Method of Evaluation [TUMETHOD] |
CLINICAL EVALUATION CT SCAN ENDOSCOPY MRI PET SCAN PET/CT SCAN PET/MRI SCAN PHOTOGRAPHY PHYSICAL EXAMINATION SCINTIGRAPHY SPIRAL CT ULTRASOUND X-RAY OTHER |
| If Other, Specify [OTHER_TUMETHOD] |
|
| Date of Procedure [TUDAT] |
|
| Evaluator [TUEVAL] |
|
| Longest Diameter [LDIAM_TRORRES] |
|
| Longest Diameter Unit [LDIAM_TRORRESU] |
mm |
| Shortest Diameter [SDIAM_TRORRES] |
|
| Shortest Diameter Unit [SDIAM_TRORRESU] |
mm |
| Check if the diameter was too small to measure [TRTOOSM] |
|
RSYN : Disease Response YN?
| Question | Response |
|---|---|
| Was the response assessment performed? [RSPERF] |
Yes No |
RS_REC : Disease Response (RECIST 1.1)
| Question | Response |
|---|
| VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT | FORM_TUNTSC | FORM_TUNT | FORM_TUNW |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Populate as 'statschoice' | |||
| DOMAIN | Domain Abbreviation | Char | Populate as 'TU' | |||
| USUBJID | Unique Subject Identifier | Char | Populate using SUBJECT variable. | Populate using SUBJECT variable. | Populate using SUBJECT variable. | |
| TUSEQ | Sequence Number | Num | Sort the records using USUBJID, TUTESTCD, TUMETHOD, TUDTC, TULNKID and set to 1 on the first record of subject and increment by 1 on subsequent records. | |||
| TUREFID | Reference ID | Char | Populate using RECORDPOSITION as a 4 character wide string with leading zeros where applicable. Concate "TUNTSC-" as a prefix to the 4 character string created using RECORDPOSITION. | Populate using RECORDPOSITION as a 4 character wide string with leading zeros where applicable. Concate "TUNT-" as a prefix to the 4 character string created using RECORDPOSITION. | Populate using RECORDPOSITION as a 4 character wide string with leading zeros where applicable. Concate "TUNW-" as a prefix to the 4 character string created using RECORDPOSITION. | |
| TUSPID | Sponsor-Defined Identifier | Char | Populate using TUSPID | Populate using TUSPID | Populate using TUSPID | |
| TULNKID | Link ID | Char | Populate using TULNKID | Populate using TULNKID | Populate using TULNKID | |
| TUTESTCD | Tumor/Lesion ID Short Name | Char | Populate as 'TUMIDENT' | Populate as 'TUMIDENT' | Populate as 'TUMIDENT' | |
| TUTEST | Tumor/Lesion ID Test Name | Char | Populate as 'Tumor Identification' | Populate as 'Tumor Identification' | Populate as 'Tumor Identification' | |
| TUORRES | Tumor/Lesion ID Result | Char | Populate as 'NON-TARGET' | Populate as 'NON-TARGET' | Populate as 'NEW' | |
| TUSTRESC | Tumor/Lesion ID Result Std. Format | Char | Populate as SDTM.TU.TUORRES | |||
| TULOC | Location of the Tumor/Lesion | Char | Populate using OTHER_TULOC if it is not null, else populate using TULOC | Populate using OTHER_TULOC if it is not null, else populate using TULOC | Populate using OTHER_TULOC if it is not null, else populate using TULOC | |
| TUMETHOD | Method of Identification | Char | Populate using OTHER_TUMETHOD if it is not null, else populate using TUMETHOD | Populate using OTHER_TUMETHOD if it is not null, else populate using TUMETHOD | Populate using OTHER_TUMETHOD if it is not null, else populate using TUMETHOD | |
| TUEVAL | Evaluator | Char | Populate as 'INVESTIGATOR' when TUEVAL='INVESTIGATOR'. Populate as 'INDEPENDENT ASSESSOR' when TUEVAL contains 'INDEPENDENT ASSESSOR'. | Populate as 'INVESTIGATOR' when TUEVAL='INVESTIGATOR'. Populate as 'INDEPENDENT ASSESSOR' when TUEVAL contains 'INDEPENDENT ASSESSOR'. | Populate as 'INVESTIGATOR' when TUEVAL='INVESTIGATOR'. Populate as 'INDEPENDENT ASSESSOR' when TUEVAL contains 'INDEPENDENT ASSESSOR'. | |
| TUEVALID | Evaluator Identifier | Char | Populate using TUEVAL. When TUEVAL contains 'INDPENDENT ASSESSOR', present the word after hyphen. | Populate using TUEVAL. When TUEVAL contains 'INDPENDENT ASSESSOR', present the word after hyphen. | Populate using TUEVAL. When TUEVAL contains 'INDPENDENT ASSESSOR', present the word after hyphen. | |
| VISITNUM | Visit Number | Num | Populate using FOLDERSEQ | |||
| VISIT | Visit Name | Char | Populate using FOLDERNAME | |||
| TUDTC | Date/Time of Tumor/Lesion Identification | Char | Populate using TUDAT after converting it to ISO 8601 format. | Populate using TUDAT after converting it to ISO 8601 format. | Populate using TUDAT after converting it to ISO 8601 format. | |
| TUDY | Study Day of Tumor/Lesion Identification | Num | Derive using SDTM.DM.RFSTDTC and SDTM.TU.TUDTC. When TUDTC is before RFSTDTC, populate using the difference between TUDTC and RFSTDTC. When TUDTC is on or after RFSTDTC, add 1 to the difference between TUDTC and RFSTDTC. |
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