SharePoint Clinical Trial Initiation and Management Template

Description of Template
The Clinical Trial Initiation and Management SharePoint template helps companies manage the clinical trial protocol – the main deliverable of the clinical trial initiation phase. The application includes templates that help manage the creation, review and approval of objectives, study design, project plan, subject selection and budget. Also included is the capability to track discussions on documents through the threaded discussion capabilities of Windows SharePoint Services 3.0. Finally, as clinical trials are concluded, the template contains workflow which can be used to archive information to a separate folder within the application template.

Activities Performed in this Application Template

  • Create a new Clinical Trial Protocol: This is typically the first action that is taken for a new clinical Trial. Using this workflow automatically generates a number of Protocol Documents that can be used to help manage the clinical trial process. Five Microsoft Office Word documents are automatically created: Objectives, Study Design, Project Plan, Subject Selection and Budget. The workflow can be modified using Microsoft Office SharePoint Designer. Once a clinical trial is created, these documents can be modified, approved and updated by members of the team.
  • Create additional Protocol Documents: Microsoft provides five standard document templates for each Clinical Trial Protocol, but trial managers may wish to create or upload additional documents, which can be managed through the application template. Each document can be placed under a particular clinical trial, assigned to an owner, given an appropriate status and given a due date, if appropriate.
  • Calendar Functionality: A simple calendar can be used to track major events and activities related to the clinical trials that are planned or in progress.
  • Document Discussions: To enable collaboration between team members, threaded discussions are enabled. Team members create discussions and reply to others, all within Windows SharePoint Services.
  • Create and Assign Tasks and Issues: The application template includes functionality to help trial managers create and manage tasks and issues for a particular clinical trial protocol. Tasks can be assigned to a particular owner and placed under a particular clinical trial. When the task is created, the content of the item is automatically sent as an email message to the owner. Issues can be created using the application template, as well. Information such as owner of the issue, priority and description are captured as well as any other issues that are related. Both tasks and issues can be viewed on the first level page of the application template.
  • Archiving: Both Clinical Trial Protocols and Protocol Documents can be ‘archived’ by simply changing the status of each to ‘Archived’. The documents are not deleted, but are no longer visible through the standard views of the application template.

Site Lists and Libraries
Clinical Trial Protocols: This document library hosts all the Clinical Trial Protocol documents, including archived versions.
Protocol Documents: This document library hosts Protocol Documents including those automatically generated for each Clinical Trial Protocol through the workflow provided in the template: Objectives, Study Design, Project Plan, Subject Selection and Budget.
Announcements: Use the announcements list to post messages on the home page of the site.
Calendar: Use the calendar list to inform team members of upcoming events and activities.
Issues: The issues list is used to track open issues related to the clinical trial protocol process.
Tasks: The tasks list is used to track open tasks related to the clinical trial protocol process.
Document Discussions: This discussion board is used to hold newsgroup-style discussion on topics relevant to the client trial protocol team.