This is an example CRF used to collect Subject Inclusion/Exclusion Criteria.
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| title | CDASH IE Metadata Specifications |
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Section 1 | Metadataspec |
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| Order | Question Text | Prompt | CRF Case Report Form Completion Instructions | Type | CDASH Collection Variable Name | SDTMIG Target Variable | SDTM Target Mapping | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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| 1 | Were all eligibility criteria met? | Met Criteria | Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled. | IEYNText | IEYN | Were all eligibility criteria met? | Met Criteria | Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled. |
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Section 2 CRF | Case Report Form Completion Instructions | Type |
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CDASH Name SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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Were all eligibility criteria met? | Met Criteria3 | Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled. | Text | IEYN | IEYN | Were all eligibility criteria met? | Met Criteria | Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled. | | What was the category of the criterion? | Criterion Type | Record whether the criterion exception was Inclusion or Exclusion. | Text | IECAT | IECAT |
What was the category of the criterion? | Criterion Type | Record whether the criterion exception was Inclusion or Exclusion. | 4 |
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| | 3 | What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met? | Exception Criterion Identifier | If the subject was not eligible, record the identifying code for each criterion that was an exception. | Text | IETESTCD | IETESTCD |
What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met? | Exception Criterion Identifier | If the subject was not eligible, record the identifying code for each criterion that was an exception. |