The TOTAL Trial

Tags: LCBRU Study Category

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 (ORDER BY DATE)
  • Assent and randomise
  • 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 (number, e.g "1.3")
  • Randomisation arm (two arms)
  • Study ID (six digit integer, default is "941"?)

New custom data group for all enrolments:

• Serious Adverse Event
  • Category
  • Date of SAE
  • Description
  • Date of report to R&D
  • Date reported to sponsor
  (delete the location and assessment fields)

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? Each study reports to different bodies (sponsor, etc). Complicated.

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

TO DO:

Write a Work Instruction

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