ProtoType is an assisted protocol authoring tool that provides a systematic framework to develop and maintain protocols throughout their life cycle. As a home-grown system developed by the NIH Clinical Center with input from investigators at the National Institutes of Health, ProtoType aims to create a system that will handle all aspects of protocol development, standardize protocol authoring while offering flexibility, and provide a standardized template to facilitate the protocol process.
ProtoType offers a customized protocol template tailored toward individual IRBs and can incorporate regulatory changes with ease. Although general guidelines for authoring and reviewing of protocols are provided, there is considerable variation among users based on clinical trial sponsors and IRB requirements that can be built into the system.
Although protocol authoring is the heart of ProtoType, the tool also incorporates several other features. As a protocol is reviewed and modified, versions can be compared for both internal and external reviewers. A personal repository keeps track of references, images, equations, and recommended language that have been used in any protocol written by the author. An informed consent tool helps with writing protocol consents. The IND Wizard helps determine whether a protocol will require an IND submission.
Access ProtoType from any web-enabled device by going to http://prototype.cc.nih.gov. The production site is up and running and can be used at any time.
Development and Support
Office of Protocol Services, Chief