Common Protocol Template

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The following resources have been made available to enable use of a streamlined model protocol template with common structure and language.

The Common Protocol Template contains sections marked as common text or text that may be used across protocols with little to no editing if the user chooses to do so.  The use of this template is at the discretion of the user.  Recommendations for modifications in future releases of the common protocol template can be submitted at any time and will be reviewed on a routine basis.

Check out our video introducing the TransCelerate Common Protocol Template Initiative.

Assets Available for Download

To access the materials below, we ask that you fill out a simple form. You only need to enter your information once to be able to download any of the materials. Please click here or on any of the files below to proceed to the download page.
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The Common Protocol Template

Template File Description
Common Protocol Template Core Template – Basic Word Edition Content template for the protocol body and appendices intended for use in all phases and disease areas, containing a common heading structure, common text, and suggested text. Open template in MS Word and begin authoring. Can be used in conjunction with CPT libraries which provide content specific to participant types and therapeutic areas.
Common Protocol Template – Technology-Enabled Edition MS Word enabled format and content template for the protocol body and appendices intended for use in all phases and disease areas, containing a common heading structure, common text, and suggested text.  Includes  features such as automated connection to the CPT libraries.  Requires installation of template and add-ins on your workstation.

In order to allow for a single core template, content unique to specific populations has been organized into libraries, and can be inserted into the Core Template. If using the Basic Word Edition, you can download the libraries separately. Libraries are integrated within the Technology Enabled Edition.

CPT Library Files Description
Healthy Volunteer Library Contains common and suggested text pertinent to studies in healthy volunteers.
Patient Library Contains common and suggested text pertinent to studies in all patients regardless of indication.
Pediatric Library Contains common and suggested text pertinent to studies in pediatric patients regardless of indication, can be used in conjunction with the Patient Library.
Alzheimer’s Library Contains content pertinent to Alzheimer’s Disease studies
Asthma Library Contains content pertinent to asthma studies.
Diabetes Library Contains content pertinent to diabetes studies.
TQT Library Contains content pertinent to Thorough QT/QTc (TQT) studies.

The Common Protocol Template Implementation Toolkit

This toolkit includes materials to facilitate the evaluation and implementation of the Common Protocol Template.

File Description Value of Using
Executive Summary A slide deck which provides a brief summary of the rationale for development of the CPT and a value proposition for adoption by companies or sponsors. Communication to company or sponsor senior leadership audiences.
Video Introduction to CPT A brief video introducing the TransCelerate Common Protocol Template Initiative. Introductory communication to various audiences.
Implementation/ Communications Slide Deck A slide deck which can be customized to fit the needs of an organization electing to assess or implement the Common Protocol Template. Content includes background on development of the template. Communication to various company or sponsor audiences including:

  • senior leadership
  • template assessment team
  • template pilot teams
  • those using the template for the first time
  • broad audiences using the template for the first time who would benefit from knowledge of the template
Summary of CPT Releases A table summarizing all CPT releases including release date, intended audience, and template version(s).  Transparency of CPT Releases.
Changes in this release:

Tools to show what’s new with the CPT. A slide deck summarizing the changes to template function and content included in the May 2017 release, and comparison versions documenting the specific changes made to CPT content. Transparency of updates to CPT. This allows authors to quickly identify any changes and add as appropriate to any protocols in development originated from the previous CPT version.
Guidance for Use of the Technical Enabled Edition of the CPT A detailed word document that contains instructions and brief videos demonstrating selected steps in the use of the Technology-Enabled edition of the CPT. Provides understanding of the functionality found in the Technology-Enabled edition of the CPT.
FAQs Frequently asked questions and responses about the Common Protocol Template, how it was developed, and how it will be maintained. Access to responses on common questions.
Mapping Exercise – Instructions & Worksheet A tool to facilitate comparison of an existing protocol template to the TransCelerate Common Protocol Template. Allows for identification, section by section, of differences in headings and content to aid in assessing impact of implementation and possible mitigations needed.
Stakeholder Map A customizable tool to assess the impact that implementation of the Common Protocol Template may have on each Stakeholder group. Allows those implementing to plan for appropriate training and communication needs.
Text color guide Color coding used within the Common Protocol Template to distinguish common, suggested, example, and instructional text. Provides understanding of the meaning of color coding used.
Resources for Protocol A list of resources for protocol authors. Provides information on authoring protocols.

Feedback on the Common Protocol Template

Once you have downloaded and reviewed the materials, we would like to receive your feedback at your convenience. Please click here to submit a response. We look forward to reviewing your comments.

Disclaimer

These materials are provided ‘AS IS’ WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.  TransCelerate and its members do not accept any responsibility for any loss of any kind including loss of revenue, business, anticipated savings or profits, loss of goodwill or data, or for any indirect consequential loss whatsoever to any person using these materials or acting or refraining from action as a result of the information contained in these materials.  Any party using these materials bears sole and complete responsibility for ensuring that the materials, whether modified or not, are suitable for the particular use and are accurate, current, commercially reasonable under the circumstances, and comply with all applicable laws and regulations.

Nothing in these documents should be construed to represent or warrant that persons using these documents have complied with all applicable laws and regulations.  All individuals and organizations using these documents bear responsibility for complying with the applicable laws and regulations for the relevant jurisdiction.

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