Getting Started with the Clinical Template Suite Basic

Getting Started with the Clinical Template Suite (Basic Word) Clinical Content & Reuse December 2019

Getting Started with the Common Protocol Template (CPT) - Basic Word • Locate the CPT files on the Trans. Celerate Clinical Content & Reuse Website, and review descriptions of content and usage • • • http: //www. transceleratebiopharmainc. com/ Locate “Our Initiatives” section of webpage, and click on “Find out more” Locate “Clinical Content & Reuse” project section, and click on “Initiative Assets” • Under "Tools and Resources, ” click on "Individual Trans. Celerate Templates for Use/CPT" to reveal all of the available resources. Locate the BWE CPT file and download. • Participant and Therapeutic Area Libraries are also available. To download any of the files, click on the file and “Save As” to add the files to your desktop or local drive. Template File (All users) CPT Core Template CPT Library Files – Participant Type (as needed) CPT Library Files – Therapeutic Areas (as needed) Healthy Volunteer Alzheimer’s Disease Diabetic Kidney Disease Patient Asthma Prostate Cancer Pediatric Breast Cancer Rheumatoid Arthritis COPD Thorough QT/QTc (TQT) CV-Safety Vaccines Diabetes Ø Instructional text provided as red hidden text available by toggling paragraph marks Ø The templates and libraries are Word documents. No other file installation is needed. • Start authoring your protocol. Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. * Confidential - NOT FOR DISTRIBUTION *

Getting Started with the SAP (Statistical Analysis Plan) Template • Locate the SAP template file on the Trans. Celerate Clinical Content & Reuse Website, and review descriptions of content and usage • • • http: //www. transceleratebiopharmainc. com/ Locate “Our Initiatives” section of webpage, and click on “Find out more” Locate “Clinical Content & Reuse” project section, and click on “Initiative Assets” • 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. Ø Instructional text provided as red hidden text available by toggling paragraph marks Ø The template is a Word document. No other file installation is needed. • Start authoring your SAP. Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. * Confidential - NOT FOR DISTRIBUTION *

Getting Started with the CSR (Clinical Study Report) Template • Locate the CSR template file on the Trans. Celerate Clinical Content & Reuse Website, and review descriptions of content and usage • • • http: //www. transceleratebiopharmainc. com/ Locate “Our Initiatives” section of webpage, and click on “Find out more” Locate “Clinical Content & Reuse” project section, and click on “Initiative Assets” • Under "Tools and Resources, ” click on "Individual Trans. Celerate Templates for Use/CSR" to reveal all of the available resources. Locate the CSR BWE file and download. Ø Instructional text provided as red hidden text available by toggling paragraph marks Ø The template is a Word document. No other file installation is needed. • Start authoring your CSR. Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. * Confidential - NOT FOR DISTRIBUTION *

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