I have been asked - numerous times - "is it possible to do 'x' with out of the box Microsoft tools?"

The list of things people ask about are numerous, but one of the most frequent requests of late is around building a clinical trials management portal.  Interestingly enough, for DIA this year (as discussed in a previous blog post), I built a CTMS demonstration using basic Microsoft tools (and very little coding).  My goal here is to share that knowledge.  And so, over the next few weeks I'm going to detail how we built a CTMS using as much out of the box as possible (and I'll give the code where it wasn't possible).

To start any discussion about application design and development (or configuration) requires a detailed list of requirements, but I want to start with a high level requirements premise: it's about the project

Think about it.  What do clinical trials managers do?  They manage projects!  A pretty fundamental thought, but boiling it down to that basic a premise allows us to make a basic architectural decision:

  • If it's about the project, then let's design the architecture around project management. 
  • Which means that we'll be using Microsoft Office Project Server as the basis for our system.

Microsoft Office Project Server, which is part of the Office SharePoint system, provides us with all the project management capabilities, plus because it is based on SharePoint it gives us all the document management capabilities that we'll need as well.

What then are the requirements for a Clinical Trials Management system?  Well, your mileage may vary, but in my estimation they are:

  • 21 CFR Part 11 Compliance - Audit trails, version histories, and electronic or digital signatures are all required.
  • Enterprise Document Management Capabilities - Version control, version histories, check-in/check-out, workflow, capture the metadata during document authoring, centrally manage the metadata taxonomy.  There are more, of course, but we'll start here.
  • Clinical Site Management - Some people will call this functionality a clinical investigators portal
    • Study based document management
    • Site specific document management
  • Task management - both for internal and external users (i.e. sites)
  • Issue management - largely for internal users
  • Task monitoring and completion reporting
  • Key Performance Indicators - both on the project level, on the site level, and roll-ups for executive dashboards

Of course, there are many more - and more detailed required for them - but this is a blog after all, so enjoy the ride as we walk through this system together!