Protocol Builder

Raising the Bar for Protocol Development


Protocol Builder® is a cloud-based protocol writing technology that makes it faster and easier to develop investigator-initiated clinical research protocols that meet IRB and regulatory standards. This robust yet simple to use application can be accessed conveniently on laptops, desktops and iPads.

Protocol Builder is based on in-depth research and interviews that identified the needs of protocol writers:

  • • 94% wanted a guided experience
  • • 89% asked for expert advice and examples
  • • 84% requested quick access to regulatory forms

Plus, it’s enhanced on an ongoing basis with the guidance of user feedback.

Key Benefits:

  • • Save significant time and effort developing protocols
  • • Improve adherence to IRB and regulatory standards
  • • Enable collaboration among contributors
  • • Advance the ability to publish research
  • • Strengthen research programs and increase study pipelines

A male lab technician viewing a specimen and recording notes on a laptop

Product Highlights

Protocol Builder offers specific benefits to meet the needs and priorities of individuals with various roles in the clinical research process.

Research Investigators
Whether you are an experienced or new research investigator, doctor, medical resident, or medical student, Protocol Builder can help you develop better protocols in less time with less effort, even if you are new to protocol writing. It’s easy to get started and simple to use. It also enables collaboration and helps avoid multiple rounds of revisions, so you can get your research up and running faster.

Research Administrators
Protocol Builder can help you enforce protocol standardization with pre-set templates and a guided experience that includes simple instructions and expert tips. It also allows institutions to add specific guidelines and use their own templates in the application. Plus, it offers features to easily, compare, track, and summarize protocol revisions. It can be implemented easily in less than 30 days, and can be integrated with your IRB, CTMS, or single sign on platforms.

Research Librarians
This technology can be a valuable addition to your e-resource collection. It streamlines the protocol writing process and promotes learning to support your research, research education, and health science programs. It also helps advance research publication with automated citation/reference functionality and the ability to reference management libraries, such as Endnote, RefWorks, Mendeley, and PubMed.

Residency Programs
Protocol Builder not only helps residents develop consistent protocols more easily, it also helps them learn as they go. It offers a guided experience developed by protocol writing experts and can bolster your program’s efforts to meet or exceed ACGME research requirements. In addition, it enables communication and collaboration to help foster mentorship.

Protocol Builder excels at saving time and reducing hassle for protocol writers, but it goes above and beyond those benefits.

Protocol Builder is secure with SSL encryption as well as password and firewall protection. It can be implemented in as little as 30 days with no time consuming or costly set up or training needed.

Saves Significant Time and Effort for Protocol Writers
Protocol Builder automatically sets up the table of contents to help ensure the right topics are included, automates time consuming tasks, such as creating the References and Glossary sections and eliminates the need to copy/paste content or rely on templates that may be missing sections.

Helps Protocol Writers Work More Efficiently
Protocol duplication allows users to repurpose existing protocol contents and references. Advanced editing tools enable users insert citations, abbreviations, glossary terms, and more. Also, Protocol Builder helps check for accuracy and completeness to avoid multiple rounds of revisions.

Boosts the Quality and Consistency of Protocols
Features including expert tips and resources improve adherence to IRB and regulatory standards, templates and relevant instructions promote standardization for easier development and review and tools help determine protocol type and whether an IND/IDE is needed.

Enables Communication and Collaboration
Users can invite colleagues and supervisors to comment on or revise protocol topics. Revisions can be tracked, compared, and accepted/rejected. Protocol writers can message reviewers directly about specific changes.

Promotes Learning and the Ability to Publish Research
Best practices, expert tips, and a robust resource center help users learn as they go. Automated citation/reference functionality makes it easier to insert references correctly. And, reference search tools, including EndNote and RefWorks, can be pulled into the application.

Strengthens Institutional Research Programs
Protocol Builder helps increase study pipelines by improving the quality of protocols, frees up resources to focus on other tasks like getting approved research off the ground and assists residency programs in meeting ACGME research requirements.

Protocol Builder offers easy to use features developed by protocol writing and usability experts.

Automatic Set Up
Enter basic information and appropriate protocol sections are set up automatically based on protocol type. Protocol Builder can help you determine the type of study and whether or not you need an IND or IDE application.

Protocol Duplication
Instead of creating a new protocol, you can duplicate an existing protocol to repurpose the contents and references.

Advanced Editing Tools
Insert references, tables, appendices, abbreviations and glossary terms easily as you write. Those sections are then set up automatically at the end of the document.

Easy to Navigate Contents Menu
Go step-by-step through the writing process or use the menu to navigate to any section. Switch to the preview mode to read through it more easily.

Expert Guidance
Refer to relevant instructions and expert tips as you go through the protocol. You’ll also find sample protocols in the Resource Center that you can use for reference or as a template.

Resource Center
Access well-written samples as well as links to important educational and regulatory information. A list of commonly used forms is also available for download.

Share and Review
Invite others to review and add comments directly into the appropriate sections. You can also download and email PDF versions.

Compare Revisions
Compare revisions made to a particular section and accept or disregard them. You can also send a message to users about the changes.

Summary of Changes
Review all recent changes to a protocol and enter a rationale for each one. This information will be used to create a Summary of Changes page, which can be included if a protocol needs to be resubmitted.

Reference Management Software Integration
Pull in reference management libraries, such as Endnote, RefWorks, Mendeley, and PubMed.

Train and Support Your Residents on Protocols with Less Effort and Pain.

Protocol Builder can help your residents learn protocol writing and research best practices as they write their protocols. Educational features include:

  • • A guided experience with contextualized tips and best practice examples
  • • Tools that help determine the type of protocol and whether an IND or IDE is needed
  • • Automatic set up of the topics needed for the protocol based on study type
  • • A resource learning center that contains links to important regulatory information, commonly required forms, protocol samples and more

This secure cloud-based protocol writing technology is available on laptops and iPads, so busy residents can access it anytime, anywhere.

Enabling Collaboration and More

Protocol Builder has many other benefits such as enabling communication between residents and supervisors. It provides a collaborative workspace that fosters mentorship and learning. It also supports the ability to publish research with automated citation functionality and the ability to import from EndNote and RefWorks.

Please take a moment to check out this brief overview of Protocol Builder for Residency Programs.

Protocol Builder helps improve the quality and consistency of clinical research protocols so they can move through internal and IRB processes more efficiently. It’s available to institutions of any size through licensing agreements. Implementation is simple with no costly training or lengthy set up time. We can also customize Protocol Builder to fit the needs of your institution. For instance, Protocol Builder can:

  • • Customize templates, instructions, or boilerplate language
  • • Incorporate existing templates into the Protocol Builder system
  • • Add educational links or forms to the Resource Center
  • • Enable single sign on and CTMS integration with your current platform and process
  • • Import reference management libraries, including Endnote, RefWorks, and Mendeley
  • • Build a custom user portal to promote user registration

Additional Resources

Protocol Builder for GME Video

Please take a moment to check out this brief overview of Protocol Builder for Residency Programs.


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