How was the Common Protocol Template Developed and What Does it Look Like?

1. How was the Common Protocol Template Developed and What Does it Look Like? November 2018

2. How was the Common Protocol Template (CPT) First Developed? Structure and Content Structure – Level 1 and 2 Headings • Main focus - Streamlined structure for logical flow • Review of structure (Table of Contents) of anonymizedmember company templates • Input from SCRS (Society for Clinical Research Sites) Site Advocacy Group Section Content • Identification of common wording in Core Backbone • Review of GCP, ICH, and EU requirements • Review of content from member company templates

3. How was the CPT Developed? Initial Advisory Committee Engagement FDA 18-Mar-2016:“Today we’re announcing a draft clinical trial protocol template developed by the Food and Drug Administration (FDA) and National Institutes of Health (NIH) that should help with that. …..We are aware of other efforts in this area, including one undertaken by TransCelerateBiopharma Inc. (TransCelerate), which has issued a common protocol template intended to be the basis for a forthcoming electronic protocol. Although our initial target audiences differ, we plan to collaborate with groups like TransCelerate to help ensure consistency for the medical product development community.” “…to inform the development of a common human readable and electronic protocol template and provide a forum for key stakeholders to inform future direction and provide know-how (Committee Charter)” eProtocol Advisory Committee “EMA has not agreed to take up a position on the Advisory Committee…..Happy to provide comments on any draft templates…” Other Advisors or Influencers

4. How was the CPT Developed? Final Template Focus on sites (investigators/study staff) to have access to protocol information. • CPT Structure and Content will provide value to Investigators, site staff, IRBs, regulators • The same information is located in the same place and means the same thing across Sponsors • Locked text (Level 1 and 2 Headings) is not to be modified or removed. “Not Applicable” is inserted if a section is not applicable. • Specific information to evaluate the ability to conduct a protocol, e.g. does the site have the patient population. • Refer to primary sources of information (e.g. Investigator Brochure) instead of duplicating information in the protocol. • Model sections and text located in Appendices to be accessible, but will not impact the flow of the core protocol-specific information

5. What Does the CPT Look Like? Libraries group and store point and click content used to populate the template Core streamlined, focused on siteneeds ParticipantLibraries Core Protocol Backbone Common Level 1 & 2 Headings Common text Used across all phases Focus on sites (investigators/study staff) Healthy Volunteer Patient Common Textcan be used “as is”- relevant across study types Pediatric Therapeutic AreaLibraries (various) Endpoint Definitionsmodeled for TAs/indications Appendicesto apply as applicable Appendices Non-study specific info, items triggered by event A sustainable Governance Modelis in development Common Protocol Template and Guidance Governance Model Implementation Toolkit Materials

6. What Does the CPT Look Like? CPT Editions • Technology Enabled Edition • An MSWord-based template with add-ins • Automation to leverage “point and click” protocol text • Capture of protocol-level metadata to facilitate content reuse and extraction • Initial Public Release: June 2016 • For Microsoft Windows-based usage, not compatible with Apple iOS. • Basic Word Edition • A document based template for use across phases and study types • Use as-is or modify current format template to reflect CPT content • Initial Public Release: December 2015

7. What does the CPT Look Like? Basic Word Edition • Word documents; No installation needed. • Locate the Basic Word Edition files on the TransCelerateCPT Website • Under” Common Protocol Template Tools and Resources,” click on the blue bar “Basic Word Edition Template and Guidelines” to reveal all of the available resources. To download the CPT BWE, click on “Basic Word Edition 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. • Start authoring your protocol.

8. What does the CPT Look Like? Basic Word Edition Instructional text provided as red hidden text available by toggling paragraph marks “Start” and “stop” of common text is indicated in green font “Start” and “stop” of common text is indicated in green font

9. What Does the CPT Look Like? Tech-Enabled EditionIt still looks like paper….but its not! The Technology Enabled Edition of the Common Protocol Template (CPT) avoids media breaks by capturing structured and unstructured information in variables available for export and reuse downstream. Libraries make model content available Common layout of content Export variables to XML or Excel for reuse in other processes Information is captured in variables

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