The purpose of the SDTM Trial Design Model is to represent a brief, clear description of the overall plan and design of a nonclinical study or clinical trial. Guidance in this section is applicable only to TIG Nonclinical and Product Impact on Individual Health use cases. In this section, the term "trial" is equivalent to "study" in the nonclinical context. Trial Design datasets contain study-level, rather than subject-level, information. Implementation of Trial Design datasets requires the explicit statement of certain decision rules that may not be addressed or may not be as explicit in the textual description of a study plan such as an approved study protocol.
The Trial Design Model provides a standardized way to describe those aspects of the planned conduct of a clinical trial shown in the study design diagrams of these examples. The standard Trial Design Datasets will allow reviewers to:
- Clearly and quickly grasp the design of a clinical trial
- Compare the designs of different trials
- Search a data warehouse for clinical trials with certain features
- Compare planned and actual treatments and visits for subjects in a clinical trial
Modeling a clinical trial in this standardized way requires the explicit statement of certain decision rules that may not be addressed or may be vague or ambiguous in the usual prose protocol document. Prospective modeling of the design of a clinical trial should lead to a clearer, better protocol. Retrospective modeling of the design of a clinical trial should ensure a clear description of how the trial protocol was interpreted by the sponsor
The TIG guides implementation for the following Trial Design datasets:
Overview
Content Tools