| # | Question | Response / annotation |
|---|---|---|
|
1
|
Type of Consent
field_001
|
DSSCAT |
|
2
|
Date of Consent Withdrawal
field_002
|
DSSTDTC DSDECOD = WITHDRAWAL BY SUBJECT DSCAT = DISPOSITION EVENT |
| # | Question | Response / annotation |
|---|---|---|
|
1
|
Is the subject a screen failure (signed an informed consent but was not randomized/registered)? If Yes, please provide the reason
field_001
|
[NOT SUBMITTED] |
|
2
|
Primary Screen Failure Reason
field_002
|
DSDECOD DSTERM when DSDECOD is not OTHER EPOCH = SCREENING DSSCAT = SCREEN FAILURE DSCAT = DISPOSITION EVENT |
|
3
|
If Primary Screen Failure Reason is 'Other' please specify
field_003
|
DSTERM when DSDECOD = OTHER |
| # | Question | Response / annotation |
|---|---|---|
|
1
|
Disposition Category
DSCAT
|
DSCAT = PROTOCOL MILESTONE |
|
2
|
Disposition Subcategory
DSSCAT
|
DSSCAT |
|
3
|
Did the subject re-consent?
DSTERM
|
DSTERM = RE-CONSENT OBTAINED / DSDECOD = INFORMED CONSENT OBTAINED [NOT SUBMITTED] [NOT SUBMITTED] |
|
4
|
Line Number
DSSPID
|
DSSPID |
|
5
|
Reason for Re-Consent
DSRECAS
|
DSRECAS in SUPPDS |
|
6
|
Protocol Version (If Protocol Amendment)
DSREFID
|
DSREFID |
|
7
|
If Other, Please Specify
DSRECAS_OTH
|
DSRECAS in SUPPDS |
|
8
|
Informed Consent Date
DSSTDAT
|
DSSTDTC |
| # | Question | Response / annotation |
|---|---|---|
|
1
|
Date Consent Form Signed
enrlment.ICDT_RAW
|
RFICDTC DSSTDTC when DSDECOD = INFORMED CONSENT OBTAINED |
|
2
|
Consent Version Number
enrlment.ICVERS
|
ICVERS in SUPPDS when DSDECOD = INFORMED CONSENT OBTAINED |
|
3
|
Protocol Version
enrlment.PRTVERS
|
PRTVERS in SUPPDS when DSDECOD = INFORMED CONSENT OBTAINED |
|
4
|
Date of Enrollment
enrlment.ENRLDT_RAW
|
DSSTDTC when DSDECOD = ENROLLED |
|
5
|
Date of Randomization
enrlment.RANDDT_RAW
|
DSSTDTC when DSDECOD = RANDOMIZED |
|
6
|
Randomization number
enrlment.RANDNO
|
DSREFID when DSDECOD = RANDOMIZED |
| # | Question | Response / annotation |
|---|---|---|
|
1
|
Did the subject complete the investigational product treatment?
field_001
|
[NOT SUBMITTED] |
|
2
|
Did the subject complete the investigational product treatment?
field_002
|
[NOT SUBMITTED] |
|
3
|
Date of completion or discontinuation
eos.EOSTDT_RAW
|
DSSTDTC |
|
4
|
Primary reason for ending treatment
eos.EOTERM
|
DSTERM DSDECOD |
| # | Question | Response / annotation |
|---|---|---|
|
1
|
Did the subject complete the study?
field_001
|
[NOT SUBMITTED] |
|
2
|
Date of completion/discontinuation
eos.EOSTDT_RAW
|
DSSTDTC |
|
3
|
Primary reason for ending study
eos.EOTERM
|
DSDECOD DSTERM when DSDECOD is not OTHER DSCAT = DISPOSITION EVENT DSSCAT = END OF STUDY |
|
4
|
If other, specify
field_004
|
DSTERM when DSDECOD = OTHER |
| # | Question | Response / annotation |
|---|---|---|
|
1
|
Subject Identifier
PT
|
USUBJID |
|
2
|
Date
EOSTDT_RAW
|
DSSTDTC |
|
3
|
Outcome
EOTERM
|
DSTERM DSDECOD DSCAT = DISPOSITION EVENT |
| # | Question | Response / annotation |
|---|---|---|
|
1
|
Subject Identifier
PT
|
USUBJID |
|
2
|
Date
EOSTDT_RAW
|
DSSTDTC |
|
3
|
Outcome
EOTERM
|
DSTERM DSDECOD DSCAT = DISPOSITION EVENT |
| # | Question | Response / annotation |
|---|---|---|
|
1
|
Subject Identifier
PT
|
USUBJID |
|
2
|
Date
EOSTDT_RAW
|
DSSTDTC |
|
3
|
Reason for Ending
EOTERM
|
DSTERM DSDECOD DSCAT = DISPOSITION EVENT |