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/