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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CDASH Variable Name CRF | Case Report Form Completion Instructions |
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SDTMIG Target SDTM Target Mapping | Controlled Terminology Code List | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 1 |
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. | Text | 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. | 2 | IECAT | What was the category of the criterion? | Criterion Type | Record whether the criterion exception was Inclusion or Exclusion. | IECAT |
Section 2 | Order | Question Text | Prompt | Case Report Form Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 2 | What was the category of the criterion? | Criterion Type | Record whether the criterion exception was Inclusion or Exclusion. |
| IETESTCD | If the subject was not eligible, record the identifying code for each criterion that was an exception.| 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 |
What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met? | Exception Criterion Identifier |