== 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@le.ac.uk
Norman Williams, norman.williams@ucl.ac.uk
Tito Castillo, tito@xperimint.uk
Sarah Lim Choi Keung, s.n.lim-choi-keung@warwick.ac.uk
M Kahn, m.o.khan@warwick.ac.uk
Lei Zhao, lei.zhao@warwick.ac.uk

=== 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?