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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