Introduction to Libraries for the Common Protocol Template

Introduction to Libraries for the Common Protocol Template Clinical Content & Reuse December 2019

Why Develop A Library? Groups and stores content that can be reused to populate the template REUSE Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. Includes instructions and content that can be applied to protocols with similar design elements, e. g. , patient population, indication. * Confidential - NOT FOR DISTRIBUTION * 2

How Do I Use the Libraries? • For the Common Protocol Template (CPT), authors ‘cut and paste’ the required suggested or common text from the libraries into the core Word document to develop their protocol. • In the e. CPT, authors will select the appropriate Population Library and, if applicable, an Indication-specific Library. These libraries are pre-populated with data, e. g. , objectives and endpoints, inclusion and exclusion criteria specific to the study design. Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. * Confidential - NOT FOR DISTRIBUTION * 3

Who/What Contributes To Library Development? • Subject Matter Experts from Member Companies • Regulatory Guidelines/Guidances • Industry Standards, e. g. , CDISC Therapeutic Area User Guides (TAUGs) • Other cross-industry initiatives (e. g. , data from Liver Safety and Cardiovascular Consortiums) Copyright © 2015 Trans. Celerate Bio. Pharma Inc. , All rights reserved. 4

5 Where Do I Find the Libraries in e. CPT? Libraries are located in the CPT Panel and can be selected as appropriate for your participant population Copyright © 2015 Trans. Celerate Bio. Pharma Inc. , All rights reserved. 5

Available Libraries – START NOW! Indications: Populations: • Patient • Healthy Volunteers • Pediatric With use of the e. CPT, specific content and instructions are available to select and autopopulate the template Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. More to Come • • • Alzheimer’s Disease Asthma Breast Cancer Cardiovascular Safety Chronic Obstructive Pulmonary Disease Diabetes Diabetic Kidney Disease Prostate Cancer Rheumatoid Arthritis Thorough QT/QTc (TQT) Vaccines * Confidential - NOT FOR DISTRIBUTION * 6

Next Steps – Where Do We Go From Here? • START USING THE LIBRARIES! • Help identify additional libraries! Support creation of Libraries for reuse (specific to patient populations, therapeutic areas, indications, functions, countries, etc. ) • Consider sharing any company designed libraries you already have Copyright © 2017 Trans. Celerate Bio. Pharma Inc. , All rights reserved. * Confidential - NOT FOR DISTRIBUTION * 7

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