Description

Inclusion/Exclusion Criteria Not Met (IE) is a Findings domain used for those criteria that cause the subject to be in violation of the inclusion/exclusion criteria. The IE domain is used to collect failures on or exceptions to the inclusion/exclusion criteria during the screening process before a subject is enrolled in a study. It is not intended to collect protocol deviations or violations that occur after enrollment; protocol deviations are collected using the DV domain.

The recommendation is that individuals involved in data collection be given an entry criteria worksheet to be used for each subject, to record the results of eligibility review. This worksheet should be considered a source document, used in monitoring activities and maintained with the subject’s files. The worksheet should identify each criterion using a unique identifier, which can be easily recorded on the CRF if a subject does not meet that criterion. If criteria lists are numbered the same for both inclusion and exclusion criteria (e.g., inclusion 001-100, exclusion 001-100), then this identifier could include a means of identifying the type of criterion (e.g., I001-I100, E001-E100). Alternatively, the criteria could be collected in 2 separate sections on the CRF labeled "Inclusion" and "Exclusion," and the output records could include the values of Inclusion or Exclusion on each record. These are only examples; an organization’s numbering scheme may be different, but some method that captures both the Inclusion or Exclusion category and the unique criterion identifier should be used.

The recommended collection method has been simplified to require recording of a single "Y/N" value in the IEYN variable to indicate whether the subject met all of the criteria. If any criterion is not met, then this is recorded in the CRF. The result value for each unmet criterion may then be derived in the tabulation IE domain from the collection of the specific criterion that was not met. In other words, if the collected criterion is an inclusion criterion that was not met, the value of "N" can be derived into IEORRES and IESTRESC for that record in the tabulation IE domain. If it is an exclusion criterion, then "Y" can be derived into IEORRES and IESTRESC to indicate that the subject met the conditions for that exclusion record in IE.

The rationale for the recommended collection method is that what is being collected in the IE CRF is aligned with the data that would be in the tabulation IE domain.

This design allows criteria to change over the life of a study or project. If inclusion/exclusion criteria are amended, then each complete set of criteria will be included in the TI domain. TIVERS is used to distinguish between versions of eligibility criteria.

Use of uniquely numbered entry criteria are recommended within a study to effectively manage protocol changes and to facilitate the collection and submission of IE data. The Inclusion/Exclusion worksheet may need to be updated and renumbered/relettered whenever a protocol amendment changes 1 or more criteria. For example, if new versions of a criterion have not been given new numbers, separate values of IETESTCD might be created by appending letters (e.g., INCL003A, INCL003B). A field could be added to the CRF to capture the version number of the criteria being used; this can be mapped to the tabulation variable TI.TIVERS. This enables the retrieval of the full text of the criterion from the code used on the CRF.

Alternatively, an implementer may choose to include the full text of each criterion (IETEST) with a result field (IEORRES) in the CRF and request the site to record explicitly the "Y" or the "N" for each criterion, but only the recommended, simplified method is presented in the IE example CRF.

Specification

TIG v1.0 Metadata Check for CDASH Domain Specification Table Beta 2

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Observation ClassDomainData Collection ScenarioImplementation OptionsOrder NumberCollection VariableCollection Variable LabelDRAFT Collection DefinitionQuestion TextPromptData TypeCollection CoreCase Report Form Completion InstructionsTabulation TargetMapping InstructionsControlled Terminology Codelist NameSubset Controlled Terminology/CDASH Codelist NameImplementation Notes
FindingsIEN/AN/A1STUDYIDStudy IdentifierA unique identifier for a study.What is the study identifier?[Protocol/Study]CharHRN/ASTUDYIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AAlthough this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation.
FindingsIEN/AN/A2SITEIDStudy Site IdentifierA unique identifier for a site within a study.What is the site identifier?Site (Identifier)CharHRN/ADM.SITEIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/A

Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site.

EDC: This should be pre-populated.

FindingsIEN/AN/A3SUBJIDSubject Identifier for the StudyA unique subject identifier within a site and a study.What [is/was] the (study) [subject/participant] identifier?[Subject/Participant] (Identifier)CharHRRecord the identifier for the subject.DM.SUBJIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/A

Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all collection domains. However, this collection variable is populated only in the tabulation DM domain.

FindingsIEN/AN/A4VISITVisit NameThe name of an encounter that encompasses planned and unplanned study interventions, procedures, and assessments that may be performed on a subject.What is the visit name?[Visit]CharR/CN/AVISITMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThe name of the clinical encounter is typically pre-printed on the CRF or displayed within the EDC for any visit-based data collection, most often in Findings domains. This Visit text description is then available in any EDC data extract for that Findings domain.
FindingsIEN/AN/A5VISDATVisit DateDate the encounter occurred (or started).What [is/was] the date of the visit?(Visit) DateCharR/CRecord the [date/start date] of the visit using theis format (DD-MON-YYYY).N/AThis field is not a tabulation variable. The date of a measurement, test, observation can be determined from the date/time of visit (VISDAT/VISTIM) and then concatenating the VISDAT/VISTIM components and populating the tabulation variable IEDTC in ISO 8601 format.N/AN/AThe date the inclusion and exclusion assessments were collected can be determined from the visit date variable (VISDAT) and applying that date to all of the observations at that visit or the collection date can be included on the Inclusion/Exclusion CRF using the date (IEDAT) field.
FindingsIEN/AN/A6IEYNAny Incl/Excl Criteria FindingsIndication whether the subject met all the eligibility requirements for this study at the time the subject was enrolled.Were all eligibility criteria met?Met CriteriaCharHRRecord Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if subject did not meet all criteria at the time the subject was enrolled.N/ADoes not map to an tabulation variable.(NY)N/AThe intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification if all other fields on the CRF were deliberately left blank.
FindingsIEN/AN/A7IEDATInclusion/Exclusion Collection DateThe date of collection of the inclusion/exclusion criteria represented in an unambiguous date format (e.g., DD-MON-YYYY).What was the date the eligibility criteria assessment was performed?DateCharORecord complete date when the eligibility assessment was performed using this format (DD-MON-YYYY).IEDTCThis does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable IEDTC in ISO 8601 format.N/AN/AA complete date is expected. The date of collection may be determined from the date of visit (VISDAT) and, if so, a separate assessment date field is not required.
FindingsIEN/AN/A8IECATInclusion/Exclusion CategoryA grouping category to denote whether the protocol entry criterion being assessed is inclusion criteria or exclusion criteria.What was the category of the criterion?Criterion TypeCharR/CCheck the appropriate box to indicate whether the criterion exception was related to the subject's inclusion or exclusion.IECATMaps directly to the tabulation variable listed in the Tabulation Target column.(IECAT)N/AThese categories have been defined in controlled terminology that must be used. Only records for criteria that are not met appear in the IE tabulation domain. IECAT must be populated. This criterion category may be collected on the CRF in a tick/checkbox format or it may be included as part of the criterion identification and mapped when the tabulation datasets are created.
FindingsIEN/AN/A9IESCATInclusion/Exclusion SubcategoryA sub-division of the IECAT values based on user-defined characteristics.What was the subcategory of the criterion?[Criterion Subtype]; NULLCharOIf collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.IESCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-defined controlled terminology. This would most commonly be either a heading or a pre-printed category value on the CRF, and not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Subcategory" can be included as the column heading. This can be used to distinguish criteria for a sub-study or to categorize the criterion as a major or minor exception.
FindingsIEN/AN/A10IETESTCDInclusion/Exclusion Criterion Short NameThe unique identifier associated with the criterion that was the exception.What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?Exception Criterion IdentifierCharHRIf the subject was not eligible, record the identifying code for each criterion that was an exception.IETESTCDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis field is required to appear on the CRF, but may be null if there are no exceptions to the inclusion/exclusion criteria. The CRF should allow multiple exceptions to be recorded. Applicants may provide a list of inclusion/exclusion criteria and the unique identifying codes to the site. The list provided should be versioned/updated when the protocol changes and the criteria are changed. Applicants should use applicant-developed controlled terminology for IETESTCD.
FindingsIEN/AN/A11IETESTInclusion/Exclusion CriterionDescriptive name of the inclusion or exclusion criterion that was the exception.What was the description of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?Exception Criterion DescriptionCharORecord the description of the criterion, if not pre-printed on the CRF. If collected on the CRF, the applicant may provide additional instructions to ensure the data is entered as intended.IETESTMaps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variable IETESTCD may be determined from the value collected in IETEST. The tabulation variables IETESTCD and IETEST are required in the tabulation datasets.N/AN/AApplicants could automatically populated the text in EDC systems when the criterion identifier is populated by the investigator. This can be verified by the PI to ensure the right exception identifier was selected.
FindingsIEN/AN/A12IEORRESI/E Criterion Original ResultAn indication of which inclusion criterion was not met or exclusion criterion was met.What is the result?(Result)CharHRIf collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.IEORRESMaps directly to the tabulation variable listed in the Tabulation Target column.N/A

(NY)

This is only a data collection field when a complete list of inclusion and exclusion criteria are included on the CRF with Yes/No response options. If the applicant collects only the criteria that are not fulfilled, then, when an inclusion criterion is not met, IEORRES is mapped to "N" and when an exclusion criterion is met, IEORRES is mapped to "Y".

Assumptions

  1. The recommendation is for only those records for criteria that are not met to be collected on the IE CRF.
  2. The complete list of inclusion/exclusion criteria and the version number of each of the criteria are provided in the SDTMIG TI dataset. The IETEST and IETESTCD values used to collect data on the IE CRF should match the values in the TI dataset.
  3. Categories IECAT and IESCAT
    1. The tabulation variable IECAT must be populated with INCLUSION or EXCLUSION. This criterion category may be collected on the CRF in a checkbox format using the collection field IECAT, or it may be included as part of the criterion identification and populated when the tabulation datasets are created.
    2. IESCAT may be used by the applicant to further categorize the exception criteria within the larger categories of Inclusion or Exclusion (e.g., Major, Minor).
    3. These categories may be collected on the CRF, or they may be used as titles on the CRF and hidden/defaulted in the operational system. If these categories are not collected on the CRF or created in the operational data management system, they are added when the tabulation datasets are created.
  4. There should be a unique IETESTCD for each unique criterion text in IETEST, and these values must match the values in the TI domain.
  5. It may be useful to collect the protocol version under which a subject was screened.
  6. The collection date (IEDAT) is the date that the IE data were recorded for the study, and not the actual date the exception occurred. The visit date (VISDAT) may be used, instead, to populate the tabulation IEDTC variable.
  7. The result (IEORRES)—"Y" or "N"—for each tabulation IETESTCD is derived or inferred from the collection of the specific criterion not met. IEORRES must be populated in the tabulation IE domain because it is a Required variable. Applicants will populate this in the operational data management system or in the creation of the tabulation datasets. When an inclusion criterion is not met, the tabulation variable IEORRES is populated with "N"; when an exclusion criterion is not met, IEORRES is populated with "Y".

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