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| Metadataspec |
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| Num | Variable Population | Implementation | Multiple Values for a Topic Variable | Product Impact on Individual Health Only: Interventions and events class datasets will conform with the record structure defined for the domain. If multiple values are reported for an intervention or event topic variable (i.e., for variables --TRT or --TERM), the applicant will split the values into multiple records or otherwise resolve the multiplicity per the applicant's data management procedures. For example, if an adverse event term of "Headache and nausea" is reported, sponsors will often split the original report into separate records and/or query the site for clarification. |
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| 1 | Prespecified interventions and events (--PRESP, --OCCUR, --STAT, REASND) | Product Impact on Individual Health Only: Interventions (e.g., concomitant medications) and events (e.g., medical history) can be collected as responses to a prespecified list of treatments or terms. In such cases: - --PRESP represents when topic variable values, specific interventions (--TRT) or events (–TERM), were prespecified at the time of data collection. Values will be "Y" (for "Yes") or a null value.
- --OCCUR represents whether prespecified interventions or events occurred or did not occur. Values will be populated for prespecified interventions and events only populated will be "Y" and "N" (for "Yes" and "No"). When an intervention or event is not prespecified, the value of --OCCUR will be null.
- --STAT and --REASND can be used to provide information about prespecified interventions and events for which there is no response (e.g., investigator forgot to ask). In such cases the value of --STAT will be "NOT DONE" and the value of --REASND will be the reason when collected.
The following table shows the population of --PRESP, --OCCUR, --STAT, and --REASND for different data collection scenarios. | Collection Scenario | --PRESP Value | --OCCUR Value | --STAT Value | --REASND Value |
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| An intervention or event was prespecified at the time of collection and occurred. | Y | Y |
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| | An intervention or event was prespecified at the time of collection and did not occur. | Y | N |
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| | An intervention or event was prespecified at the time of collection with no response and no reason collected. | Y |
| NOT DONE |
| | An intervention or event was prespecified at the time of collection with no response and reason collected. | Y |
| NOT DONE | Forgot to ask. | | A spontaneously reported intervention or event was collected. |
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| Reason for an Action or Activity | For Interventions class domains: - --INDC will represent the medical condition for which the intervention was given, when collected.
- --ADJ will represent the reason for an adjustment to exposure, when collected.
For Events class domains, reasons for performing an activity will be represented using nonstandard variable(s) in the SUPP-- dataset with QNAM = --REAS. |
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The following are conventions for variable population in Findings class domains.
| Metadataspec |
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| Num | Variable Population | Implementation |
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| 1 | Result Precision | - For numeric non-derived data, --ORRES will represent results to precision collected. Precision will not be artificially changed due to computer storage considerations.
- For numeric derived data, --ORRES and --STRESC will represent the correct number of significant figures based upon the calculation used to derive the value. Trailing zeroes will be retained when significant.
| | 2 | Standardized Units | Applicants may standardize units within a study for a given test per scientific and regulatory requirements. Standardization of units is recommended when data for the same test are collected via different sources using different units. In such cases, --ORRESU will represent the collected unit and --STRESU will represent the standardized unit. | | 3 | Original and Standardized Results (--ORRES, --ORRESU, --STRESC, --STRESU, --STRESN) | If supplemental free text is collected for a result via CRF, then refer to Section x.x, Free Text from Case Report Forms (CRFs). For responses collected via QRS instruments, refer to QS domain assumptions. For all other results: 
- --ORRES will be populated with the result of the measurement or finding as originally collected or received, using controlled terminology when applicable.
- When applicable, the unit associated the value of --ORRES will be populated in --ORRESU, using controlled terminology.
- Values will be populated in --STRESC when --ORRES is populated. The value of --STRESC will be:
- Derived by the conversion of numeric values in --ORRES to numeric values with standard units. Standard units will be represented in --STRESU using controlled terminology.
- Numeric --ORRES values with characters attached (e.g., a greater than (>) or less than (<) sign) will be converted to standard units and the value of --STRESC will maintain the attached character (e.g., >10,000, <1).
- The assigned of the value of --ORRES.
- For nonclinical studies, in the Macroscopic and Microscopic Findings (MA/MI) domains, --ORRES may contain a finding with multiple concatenated modifiers. In this case, --STRESC would represent only the finding without the modifiers.
- Numeric values represented in --STRESC will be assigned to --STRESN. If --STRESC is a character value, then, --STRESN will be null.
- Numeric values with attached characters (e.g., >10,000, <1) are considered to be character results and will not be populated in --STRESN.
| | 4 | Reason Test Performed (--REASPF) | --REASPF will represent the reason a test was performed, if collected. | | 5 | Tests Not Done | When an entire examination (e.g., Laboratory Test Results (LB)), a group of tests (e.g., hematology or urinalysis), or an individual test (e.g., glucose) is not done for a USUBJID, POOLID, or SPTOBID and this information is explicitly captured with or without the reason for not collecting the information, record(s) can be created in the dataset to represent these data. In such cases, applicants may include: - Individual records for each test not done for each subject or pool; or
- One record for each subject or pool for a group of tests that were not done. In such cases:
- The paired values of --TESTCD and --TEST will represent a general description of testing in scope for the domain and will be used for all groupings of not done tests within the domain.
- --TESTCD will be the domain code concatenated with the word "ALL".
- --TEST will be the domain description per controlled terminology.
- --CAT will represent the group of tests not done.
- --ORRES will be null.
- --STAT will be "NOT DONE".
- --REASND will be the reason the group of tests was not done, if collected.
For example, if a group of hematology or urinalysis tests represented in the LB domain are not done for a subject, then: | USUBJID | LBTESTCD | LBTEST | LBCAT | LBORRES | LBSTAT | LBREASND |
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| ABC-001 | LBALL | Laboratory Test Results | HEMATOLOGY |
| NOT DONE |
| | ABC-001 | LBALL | Laboratory Test Results | URINALYSIS |
| NOT DONE | No urine specimen present |
| | 56 | Biological Significance | Nonclinical Only: - For assessments of biological significance when the overall interpretation is a record in the domain, use the supplemental qualifier (SUPP--) record (with QNAM = --BIOSIG) linked to the record that contains the overall interpretation or a particular result.
- An example would be a QNAM value of LBBIOSIG in SUPPLB with a value of "Y", indicating that a lab result for albumin of 30 mg/mL was biologically significant.
- Biological significance is not the same as the concepts of normal and abnormal, which are generally represented in --ORRES.
| | 67 | Clinical Significance | Product Impact on Individual Health Only: - For assessments of clinical significance when the overall interpretation is a record in the domain, use the --CLSIG (Clinically Significant) variable on the record that contains the overall interpretation or a particular result.
- For example, EGCLSIG = "Y" indicates that an ECG result of "ATRIAL FIBRILLATION" was clinically significant.
- Clinical significance is not the same as the concepts of normal and abnormal and lab values out of normal range which are generally submitted in --ORRES and normal range/indicator variables respectively.
| | 78 | Derived Records |
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