|  | 10 |  | 
          
            |  | 11 | === Civi object model implications === | 
          
            |  | 12 |  | 
          
            |  | 13 | New group for patients: TOTAL | 
          
            |  | 14 |  | 
          
            |  | 15 | New 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 |  | 
          
            |  | 25 | New custom data group for TOTAL enrolments: | 
          
            |  | 26 | * TOTAL | 
          
            |  | 27 | * Version of consent used | 
          
            |  | 28 | * Randomisation arm | 
          
            |  | 29 | * Study ID | 
          
            |  | 30 |  | 
          
            |  | 31 | New custom data group for all enrolments: | 
          
            |  | 32 | * Serious Adverse Event | 
          
            |  | 33 | * Category | 
          
            |  | 34 | * Description | 
          
            |  | 35 |  | 
          
            |  | 36 | 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? | 
          
            |  | 37 |  | 
          
            |  | 38 | See here: http://www.nres.nhs.uk/applications/after-ethical-review/safetyreports/safety-reports-for-all-other-research/ | 
          
            |  | 39 |  |