= The TOTAL Trial =

A randomised trial of routine aspiration thrombectomy with PCI versus PCI alone in patients with STEMI undergoing primary PCI

http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=12838

The TOTAL study will use CiviCRM to track recruitment data. All other study data will be recorded in study-specific applications specified by the study funders.

Contact for this study is Emma Parker.

=== Civi object model implications === 

New group for patients: TOTAL

New study: TOTAL

* Standard Timeline
  * Assent / recruitment
  * Randomisation ( 0 days)
  * Consent (1 day)
  * Follow up visit (30 days)
  * Follow up visit (180 days)
  * Follow up visit (365 days)

New custom data group for TOTAL enrolments: 
* TOTAL
  * Version of consent used
  * Randomisation arm
  * Study ID

New custom data group for all enrolments: 
* Serious Adverse Event
  * Category
  * Description

Maybe we could adjust the SAE reporting data so that it is possible to print from CiviCRM the necessary SAE report form to submit to NRES?

See here: http://www.nres.nhs.uk/applications/after-ethical-review/safetyreports/safety-reports-for-all-other-research/