| | 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 | |