CiviCRM for Study Management and Monitoring

At the BRISSKit Hack Day, 24 February 2015, we explored using CiviCRM for Study Management.

Project Team:

Nick Holden, nrh11@… Norman Williams, norman.williams@… Tito Castillo, tito@… Sarah Lim Choi Keung, s.n.lim-choi-keung@… M Kahn, m.o.khan@… Lei Zhao, lei.zhao@…

Demo Site

For the time being, the demo site (a BRISSkit VM) is available at ​http://briss-civi.cloudapp.net/

Assumptions

For today's proof of concept hack, we are limiting ourselves to the concept of studies conducted within a single hospital research site. Future development of the model should allow for modelling multi-site and even international studies.

Objectives

To allow the monitoring of studies through the approval stage and eventual live status to completion and archiving.

A basic level of anonymous access to allow site of which studies are being run, and their state.

Object Model

Starting from a vanilla Drupal 7, CiviCRM 4.5.6 site, we made the following changes...

• Contact Types
  • Individuals
    • Researchers
    • R and D staff
    • Administrative staff
  • Households - PROBABLY NOT USED
  • Organisations
    • Department
    • Ethics committee
    • Funding body
• Relationships
  • "works in" (researcher - department)
• Cases
  • Case Types
  • Case roles
    • PI
    • Research Nurse
    • R & D officer
    • Ethics committee
• Activities
  • Apply for funding
  • Funding approval
  • Ethics approval - assign to the ethics committee
• Custom data
  • ?

References

Study workflow (including steps required before a study can start):

​http://www.ct-toolkit.ac.uk/routemap

Trial Management and Monitoring:

​http://www.ct-toolkit.ac.uk/__data/assets/pdf_file/0007/35962/monitoring-procedures-workstream.pdf

Trial Monitoring Option Checklist:

​http://www.ct-toolkit.ac.uk/__data/assets/pdf_file/0004/35959/trial-monitoring-option-checklist.pdf

Risk-adapted approaches to monitoring are required. Type A (low risk) e.g. questionnaire study, Type B (intermediate risk) e.g. study using a CE marked device, Type C (high risk) e.g. CTIMP. Each study will need a bespoke monitoring plan according to risk and resources, but for this exercise shall we restrict ourselves to these three examples?