Getting Started with the Basic Word Editions BWEs

Getting Started with the Basic Word Editions (BWEs) November 2018

Getting Started with the CPT Basic Word Edition (BWE) • Locate the CPT files on the Trans. Celerate Common Protocol Template 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 “Common Protocol Template” project section, and click on “Initiative Assets” • Under ”Tools and Resources, ” click on the blue bar “Basic Word Edition Templates and Guidelines” to reveal all of the available resources. To download the CPT BWE, click on “Basic Word Edition - CPT Core Template. ” • 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 paragraph marks Ø Instructional text provided as red hidden text available by toggling 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 Common SAP (Statistical Analysis Plan) • Locate the SAP template file on the Trans. Celerate Common Protocol Template 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 “Common Protocol Template” project section, and click on “Initiative Assets” • Under ”Tools and Resources, ” click on the blue bar “Basic Word Edition Templates and Guidelines” to reveal all of the available resources. To download the Common SAP template, click on “Basic Word Edition - SAP Core Template. ” 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 Common CSR (Clinical Study Report) • Locate the CSR template file on the Trans. Celerate Common Protocol Template 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 “Common Protocol Template” project section, and click on “Initiative Assets” • Under ”Tools and Resources, ” click on the blue bar “Basic Word Edition Templates and Guidelines” to reveal all of the available resources. To download the Common CSR template, click on “Basic Word Edition - CSR Core Template. ” 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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