Changes between Version 1 and Version 2 of TOTAL Study


Ignore:
Timestamp:
10/24/13 10:21:41 (11 years ago)
Author:
Nick Holden
Comment:

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  • TOTAL Study

    v1 v2  
    1 TOTAL
     1= The TOTAL Trial =
    22
    3 The Total Trial
    43A randomised trial of routine aspiration thrombectomy with PCI versus PCI alone in patients with STEMI undergoing primary PCI
    54
    … …  
    98
    109Contact for this study is Emma Parker.
     10
     11=== Civi object model implications ===
     12
     13New group for patients: TOTAL
     14
     15New study: TOTAL
     16
     17* Standard Timeline
     18  * Assent / recruitment
     19  * Randomisation ( 0 days)
     20  * Consent (1 day)
     21  * Follow up visit (30 days)
     22  * Follow up visit (180 days)
     23  * Follow up visit (365 days)
     24
     25New custom data group for TOTAL enrolments:
     26* TOTAL
     27  * Version of consent used
     28  * Randomisation arm
     29  * Study ID
     30
     31New custom data group for all enrolments:
     32* Serious Adverse Event
     33  * Category
     34  * Description
     35
     36Maybe 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?
     37
     38See here: http://www.nres.nhs.uk/applications/after-ethical-review/safetyreports/safety-reports-for-all-other-research/
     39