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explanations and example text) to create clinical-grade, high-quality documents that ensure consistency across CSRs. Taking into account the various types of clinical studies with differing designs, objectives, and endpoints, CSR authors should work with their clinical study team
The Trial Summary (TS) domain is a trial-level dataset that allows for the submission of a high-level view of a study in a structured format. Each record contains the value of a parameter or characteristic of the trial.
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Trial Summary (TS) provides a quick overview of the submitted clinical trial to the reviewer, without the need to comb through the entire protocol. TS has quickly evolved from a fancy optional dataset in the past to a required dataset, in the absence of which a submission package would receive a Technical Rejection as shown in . Figure 1
15 Σεπ 2020 · Executive Summary. The executive summary, while placed at the front of the document prior to the introduction, is often easiest to construct last, as an overall summary of the entire document. The key elements of this summary should briefly recap the study design and objectives.
The EU Clinical Trials Regulation 536/2014 (Article 37) (EU CT Regulation) requires sponsors to provide summary results of clinical trials in a format understandable to laypersons. These layperson summaries will be made available in a new EU database once it becomes available and is approved according to the timelines set forth in the Regulation.
Summarize the results of the Validation Study and conclude whether or not the Test Method is appropriate for its intended use base on the validation results given in this report and the...
