How was the SAP Template Developed and What
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How was the SAP Template Developed and What Does it Look Like? Clinical Content & Reuse December 2019
Statistical Analysis Plan (SAP) Template - Benefits Integration of templates The SAP Template seamlessly integrates with the CPT and CSR template simultaneously decreasing the overall complexity and variability between SAP template structures without limiting or dictating the type of analyses conducted resulting in increased ease of use and efficiency for sites and sponsors leading to downstream improvements in quality for patients. Efficiency of authoring The seamless content re-use and consistency in structure between CPT, and SAP and CSR templates ensures that content can be efficiently authored with end uses clearly understood. Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. * Confidential - NOT FOR DISTRIBUTION *
How was the SAP Template Developed? Structure and Content Structure – Level 1 and 2 Headings • Main focus - Consistency with CPT and facilitate content reuse • FDA feedback on CPT structure (Statistical Analysis sections) on CPT version 2 Section Content • Review of content from Member Company templates • Review of ICH and other reference materials* • Incorporated estimands concept based upon draft ICH addendum (ICH E 9 R 1) * Gamble C, Krishan A, Stocken D, et al. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. JAMA. 2017; 318(23): 2337– 2343 Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. * Confidential - NOT FOR DISTRIBUTION *
What does the SAP Template Look Like? Basic Word Edition • Word documents; No installation needed. • Locate the Basic Word Edition files on the Trans. Celerate Clinical Content & Reuse Asset page. • Under "Tools and Resources, ” click on "Individual Trans. Celerate Templates for Use/SAP" to reveal all of the available resources. Locate the SAP BWE file and download. • Start authoring your SAP document. Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. * Confidential - NOT FOR DISTRIBUTION *
What does the SAP Template Look Like? Basic Word Edition Instructional text provided as red hidden text available by toggling paragraph marks (red font) Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. Example text is indicated in green font * Confidential - NOT FOR DISTRIBUTION * 5
What does the SAP Template Look Like? e. SAP (Tech-Enabled Edition) • Word documents; No installation needed. • Locate the e. Template Edition files on the Trans. Celerate Clinical Content & Reuse Asset page. • Under "Tools and Resources, ” click on "e. Templates" to reveal all of the available resources. Locate the e. SAP file and download. • Start authoring your SAP document. Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. * Confidential - NOT FOR DISTRIBUTION *
What does the SAP Template Look Like? e. SAP (Tech-enabled Edition) Instructional text provided as red hidden text available by toggling paragraph marks (red font) Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. Example text is indicated in green font * Confidential - NOT FOR DISTRIBUTION * 7