A standalone protocol is considered best practice for human subjects research. It ensures that the critical elements of the research study are documented in order to increase quality control and ensure that the study description contains all the crucial elements from the start. It is a key document for ensuring standardization of research procedures and data collection.
A research protocol:
- is required by the International Council for Harmonisation’s Good Clinical Practice guidelines
- simplifies VCU's Institutional Review Board (IRB) process
- simplifies the VCU Scientific Review Committee’s review process
- must be uploaded to ClinicalTrials.gov for those studies which are subject to registration and results reporting
- may be requested as supporting information by some journal publishers
- may be required by funding agencies
The Wright Center is excited to make Protocol Builder® available to all members of the VCU community.
Log into Protocol Builder using your VCU eID and password.
What is Protocol Builder?
Protocol Builder is a secure, cloud-based technology that provides organization, guidance and collaboration tools for writing your interventional or observational research protocols.
How can Protocol Builder help me?
Protocol Builder provides 11 unique protocol templates that set the outline and structure for your protocol. Collaboration with both internal and external colleagues and contributors is easy with the ability to add people as editors or reviewers, compare protocol versions, send requests for changes and see revisions. You can import and share your reference library and Protocol Builder will automatically number your citations and references.
How does Protocol Builder work?
When you select a template, Protocol Builder will create a shell document containing all of the standard sections that should be included in that type of protocol. Within each section there is help information that tells you what information should be included in that section. Some of the sections include sample text that can be imported and edited for your study.
You can add collaborators at any time in the Cover section. If your collaborators are at VCU or VCU Health and have previously logged into Protocol Builder, you can find them with their email address. If they are not in the database, ask them to log into Protocol Builder and they will be added automatically. If they are outside of VCU and VCU Health, you can add them by clicking the Search Database button and entering their email address and information.
You can type directly into the edit box of each section or cut and paste from existing documents. You can easily add symbols, abbreviations, glossary terms, references, footnotes, tables and appendix documents – Protocol Builder will store them and automatically number, sort, and create lists for your document.
Each section can be saved as a draft or marked as complete. When you save a section, you have the option to email other contributors to ask them to review or revise the section. For each section you can select which collaborators will receive the email, and the email notification will only address that section in order to reduce the number of unnecessary emails to your colleagues.
When you publish your completed protocol, Protocol Builder adds a version number and tracks changes between versions for you.
Where can I get help?
If you have never used Protocol Builder before, we suggest you start by taking a tour and/or watching one of the webinar training videos offered inside the software. If you have questions, please contact the Wright Center’s Research Navigator, Maureen Olmsted, Ph.D., at firstname.lastname@example.org or 804-828-9226.
National Institutes of Health (NIH)
The NIH also has a cloud-based protocol development tool, which has templates for Phase 2 or 3 Clinical Trials and Behavioral/Social Science Research Involving Human Subjects. Researchers will need to create an account and profile. The templates are also available as word documents. NIH’s Institutional Review Board also has helpful protocol templates for IND, prospective data, secondary data and repository studies.
The SPIRIT group provides a number of helpful resources including a checklist and an e-protocol template system.