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

2. Getting Started with the CPT Basic Word Edition (BWE)
Locate the CPT files on the TransCelerate Common Protocol Template Website, and review descriptions of content and usage
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.
Instructional text provided as red hidden text available by toggling paragraph marks
The templates and libraries are Word documents. No other file installation is needed.
Start authoring your protocol.
Template File (All users)
CPT Library Files – Participant Type (as needed)
CPT Library Files – Therapeutic Areas (as needed)
CPT Core Template
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
Legally approved Oct-2018

3. Getting Started with the Common SAP (Statistical Analysis Plan)
Locate the SAP template file on the TransCelerate Common Protocol Template Website, and review descriptions of content and usage
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.”
Instructional text provided as red hidden text available by toggling paragraph marks
The template is a Word document. No other file installation is needed.
Start authoring your SAP.
Legally approved Oct-2018

4. Getting Started with the Common CSR (Clinical Study Report)
Locate the CSR template file on the TransCelerate Common Protocol Template Website, and review descriptions of content and usage
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.”
Instructional text provided as red hidden text available by toggling paragraph marks
The template is a Word document. No other file installation is needed.
Start authoring your CSR.
Legally approved Oct-2018

5. Thank you