Trial Disease Assessments provides information on the planned protocol-specified disease assessment schedule when those disease assessments cannot be expressed using Trial Visits.
In oncology studies, compliance with the disease-assessment schedule is essential to reduce the risk of assessment time bias. The TD domain makes possible an evaluation of assessment time bias from SDTM-based datasets by allowing comparison of the planned schedule of assessments against the actual occurrence of the efficacy assessments in order to determine the degree of compliance. TD has limited utility outside oncology (and indeed has limited utility within oncology studies). It was developed specifically with Response Evaluation Criteria in Solid Tumors (RECIST) in mind and, in particular, for studies with progression-free survival (PFS) endpoints where an assessment time bias analysis is appropriate.
Trial Disease Assessments—One Record per Planned Constant Assessment Period
SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| # | Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STUDYID | Study Identifier | Char | Identifier | C83082 | A sequence of characters used by the sponsor to uniquely identify the study. | |||||
| 2 | DOMAIN | Domain Abbreviation | Char | Identifier | C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "TD". | ||||
| 3 | TDORDER | Sequence of Planned Assessment Schedule | Num | Timing | A number given to ensure ordinal sequencing of the planned assessment schedules within a trial. | ||||||
| 4 | TDANCVAR | Anchor Variable Name | Char | Timing | A reference to the date variable name that provides the start point from which the planned disease assessment schedule is measured. This must be referenced from the ADaM subject-level (ADSL) dataset (e.g., ANCH1DT). Note: TDANCVAR is to contain the name of a reference date variable name. | ||||||
| 5 | TDSTOFF | Offset from the Anchor | Char | ISO 8601 duration | Timing | A fixed offset from the date provided by the variable referenced in TDANCVAR. This is used when the timing of planned cycles does not start on the exact day referenced in the variable indicated in TDANCVAR. The value of this variable will be a non-negative duration. | |||||
| 6 | TDTGTPAI | Planned Assessment Interval | Char | ISO 8601 duration | Timing | The planned interval between disease assessments. | |||||
| 7 | TDMINPAI | Planned Assessment Interval Minimum | Char | ISO 8601 duration | Timing | The lower limit of the allowed range for the planned interval between disease assessments. | |||||
| 8 | TDMAXPAI | Planned Assessment Interval Maximum | Char | ISO 8601 duration | Timing | The upper limit of the allowed range for the planned interval between disease assessments. | |||||
| 9 | TDNUMRPT | Maximum Number of Actual Assessments | Num | Record Qualifier | This variable must represent the maximum number of actual assessments for the analysis that this disease assessment schedule describes. In a trial where the maximum number of assessments is not defined explicitly in the protocol (e.g., assessments occur until death), TDNUMRPT should represent the maximum number of disease assessments that support the efficacy analysis, encountered by any subject across the trial at that point in time. |
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