L4C_RA0091

Data Collection (Domain, Table, etc.)	Model	State	Updated	Open Discrepancies	Waiting for Medical Review	Records	Waiting for Coding
DM - Demographics	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6	5	15	1,431	15
SUPPDM - Supplemental Demographics	SDTM	Reviewed	about a month ago02 Feb 2019 10:16 v6	3	1	1,431	0
SE - Subject Elemeents	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v9		6	1,431	0
SV - Subject Visits	SDTM	Reviewed	about a month ago02 Feb 2019 10:16 v6	2		3,855	0
CO - Comments	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v4			123	0
CM - Concomitant Medications	SDTM	Reviewed	about a month ago02 Feb 2019 10:16 v11			931	14
SUPPCM - Supplemental Concomitant Medications	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			931	0
SU - Substance Use	SDTM	Reviewed	about a month ago02 Feb 2019 10:16 v6	3	14	1,431	0
SUPPSU - Supplemental Substance Use	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v3	1	9	1,431	0
EX - Exposure	SDTM	Reviewed	about a month ago02 Feb 2019 10:16 v5			1,431	0
SUPPEX - Supplemental Exposure	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			1,431	0
AE - Adverse Events	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			788	0
SUPPAE - Supplemental Adverse Events	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			788	0
MH - Medical History	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			1,431	0
SUPPMH - Supplemental Medical History	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			1,431	0
CE - Clinical Events	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
DS - Disposition	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
SUPPDS - Supplemental Disposition	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
DV - Protocol Deviations	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
SUPPDV - Supplemental Protocol Deviations	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
EG - ECG Test Results	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
SUPPEG - Supplemental ECG Test Results	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
LB - Laboratory Test Results	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
SUPPLB - Supplemental Laboratory Test Result...	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
QS - Questionnaires	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
VS - Vital Signs	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
VS - Vital Signs	EDC	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
MB - Microbiology Specimen	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
PC - PK Concentrations	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
SUPPPC - Supplemental PK Concentrations	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
IE - Inclusion/Exclusion Criteria Not Me...	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
PE - Physical Examination	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
SC - Subject Characteristics	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
DA - Drug Accountability	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
MS - Microbiology Susceptibility Test	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
PP - PK Parameters	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
SUPPPP - Supplemental PK Parameters	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
FA - Findings About	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
TA - Trial Arms	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
TV - Trial Visits	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
TS - Trial Summary	SDTM	As Collected	about a month ago02 Feb 2019 10:16 v6			890	0
Subjects Over 50 with Severe AEs	EDC	As Collected	about a month ago02 Feb 2019 10:16 v2			890	0

Discrepancy ID	Discrepancy Text	Status	Key	Source	Check Type	Created	Updated
Q313-12	Any AEs? is blank. Please, provide the missing data	Open ---	USUBJID = 100008	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q318-46	Any AEs is No but multiple log lines have been entered. Please correct.	Open ---	USUBJID = 100012	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q313-11	Birth Date is blank. Please provide the missing data.	Open ---	USUBJID = 100019	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q355-44	Birth Date is not in expected format. Please correct.	Open ---	USUBJID = 100008	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q320-90	Date entered is a future date. Please correct.	Open ---	USUBJID = 100012	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q313-13	Vital signs row has BMI that doesn't match height or weight and we don't know which is wrong.	Open ---	USUBJID = 100014	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q313-15	Birth Time is not in expected format. Please correct.	Open ---	USUBJID = 100019	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q313-14	Any Meds? is blank. Please provide the missing data.	Open ---	USUBJID = 100008	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q313-17	Any Meds? Is No, but information is present. Please correct.	Open ---	USUBJID = 100012	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q313-18	Not taken Prior but Start Date is before the Date of Informed Consent. Please correct	-- Candidate to Close -	USUBJID = 100014	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q313-20	Taken Prior to Study is Yes, but Start Date is after Date of Consent. Please correct.	-- Candidate to Close -	USUBJID = 100019	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q314-01	Start Date is after the Date of Subject Completion/Discontinuation. Please correct.	-- Candidate to Close -	USUBJID = 100008, AETERM = "Headache", AESTD = "2/19/2019"	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q314-02	The AE Toxicity Grade is not recorded as "Life Threatening Event" however "Is the adverse event Life Threatening?" is recorded as Yes. Please correct.	-- Candidate to Close -	USUBJID = 100012	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q314-03	Severity is blank. Please provide the missing data.	Open ---	USUBJID = 100014	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16
Q314-24	Any AEs is Yes, but Severity is blank. Please provide the missing data.	Open ---	USUBJID = 100019	DM.AGE	Missing Data	about a month ago02 Feb 2019 10:16	about a month ago02 Feb 2019 10:16

Check Code	Logic Text	Discrepancy Message	Open Discrepancies	Check Type	Reference Item(s)	Auto-close if resolved	Trigger source notification
AE_0010	Any AEs? must be present.	Any AEs? is blank. Please, provide the missing data	6	Missing Data	Any AEs?	Yes	Yes
AE_0021	If Any AEs is No then there must only be one log/add entry line present (with line number = 1).	Any AEs is No but multiple log lines have been entered. Please correct.	3	Conflicting Data	Line Number	Yes	Yes
DM_0023	Birth Date must be present.	Birth Date is blank. Please provide the missing data.		Missing Data	Birth Date	Yes	Yes
DM_0030	Birth Date must have correct format. Non-conformant data are dates such as 32/JAN/2011 or...specified as unknown).	Birth Date is not in expected format. Please correct.	2	Non-conformant Data Type	Birth Date	Yes	Yes
DM_0031 Disabled	Birth Date must be less than or equal to the System Date.	Date entered is a future date. Please correct.		Future Date	System Date	Yes	Yes
DM_0040	Birth Date must be before than or equal to the Date of First Visit.	Birth Date is after the Date of First Visit. Please correct.		Conflicting Data/td>	Birth Date	Yes	Yes
DM_0041	Birth Time must have correct format. Non-conformant data are times not between 00:00 and 23:59...stem allows this).	Birth Time is not in expected format. Please correct.		Non-conformant Data Type	American Indian or Native American	Yes	Yes
CM_0050	Any Meds? must be present.	Any Meds? is blank. Please provide the missing data.	5	Missing Data	Any Meds?	Yes	Yes
CM_0051	If Any Meds? is No then Line Number Medication or Therapy, Specific Medication or...must be blank.	Any Meds? Is No, but information is present. Please correct.	1	Conflicting Data	Any Meds?	Yes	Yes
CM_0060	If Taken Prior to Study? is No or blank, Start Date must be after or equal to the Date of Informed Consent. Updated source Compare	Not taken Prior but Start Date is before the Date of Informed Consent. Please correct.		Conflicting Data	TakenPriorToStudy?	Yes	Yes
CM_0061	If Taken Prior to Study? is Yes, Start Date must be before or equal to the Date of Informed Consent.	Taken Prior to Study is Yes, but Start Date is after Date of Consent. Please correct.		Conflicting Data	TakenPriorToStudy?	Yes	Yes
CM_0070	Start Date must be before or equal to the Date of Subject Completion/Discontinuation.	Start Date is after the Date of Subject Completion/Discontinuation. Please correct.		Conflicting Data		Yes	Yes
AE_0080	If Toxicity Grade does not equal "Life Threatening Adverse Event" then Life Threatening must be No or blank.	The AE Toxicity Grade is not recorded as "Life Threatening Event" however "Is the adverse event Life Threatening?" is recorded as Yes. Please correct.		Conflicting Data		Yes	Yes
AE_0090	Severity must be present.	Severity is blank. Please provide the missing data.	7	Missing Data	Severity	Yes	Yes
AE_0100	If Any AEs is Yes, Severity must be present.	Any AEs is Yes, but Severity is blank. Please provide the missing data.		Missing Data		Yes	Yes

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34 matches
L4C_RA0090 Adverse Event Show form

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090

Adverse Event
Show 4 variables Hide 4 variables

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
CDASH 1.1 Global Standard Adverse Event

SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

Supplemental Medical History

MHOSDTC

Onset of What Symptoms Date
L4C_RA0090 Adverse Event

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
CDASH 1.1 Global Standard Adverse Event

SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

Supplemental Medical History

MHOSDTC

Onset of Symptoms Date
L4C_RA0090 Adverse Event

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
CDASH 1.1 Global Standard Adverse Event

SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

Supplemental Medical History

MHOSDTC

Onset of What Symptoms Date
L4C_RA0090 Adverse Event

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?

Done

Pull from standards or similar studies

34 matches
L4C_RA0090 Adverse Event Show form

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090

Adverse Event
Show 4 variables Hide 4 variables

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
CDASH 1.1 Global Standard Adverse Event

SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

Supplemental Medical History

MHOSDTC

Onset of What Symptoms Date
L4C_RA0090 Adverse Event

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
CDASH 1.1 Global Standard Adverse Event

SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

Supplemental Medical History

MHOSDTC

Onset of Symptoms Date
L4C_RA0090 Adverse Event

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
CDASH 1.1 Global Standard Adverse Event

SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

Supplemental Medical History

MHOSDTC

Onset of What Symptoms Date
L4C_RA0090 Adverse Event

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?

Done

L4C_RA0091

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