DME

Global Validation Rule Standards

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 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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
AE_0010 Any AEs? must be present. Any AEs? is blank. Please, provide the missing data 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. 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. 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. 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. 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. 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. 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