| | 11 | |
| | 12 | == Study Overview |
| | 13 | |
| | 14 | CAE will be very similar to SCAD in the way that patients are recruited and the data that is collected. |
| | 15 | |
| | 16 | 1. Participants will register through the web portal. This has been created and is waiting for Rob to make the necessary amendments. |
| | 17 | 2. Participants from the web portal will be invited to take the online survey and will be entered into a registry. |
| | 18 | 3. Additional participants for the registry, identified through searching medical records, will be invited to fill out a paper copy of the same survey, which will be keyed into the system by a member of the CAE team. |
| | 19 | 4. The survey will be similar, but not the same, to the one for the SCAD study. |
| | 20 | 5. A sub-set of participants from the CAE Registry will be invited to attend a site for deep phenotyping. |
| | 21 | 6. Participants who are not invited for deep phenotyping will be sent a mouth swab for collecting a DNA sample. |
| | 22 | 7. Deep phenotyping will involve filling out a more detailed questionnaire in REDCap and take various other tests, including MRIs, echos, etc, and the taking of a blood sample. |
| | 23 | 8. Recruiting at the study will be undertaken at several site: |
| | 24 | - Leicester |
| | 25 | - Oxford |
| | 26 | - Cambridge |
| | 27 | - Guys and St Thomas' |
| | 28 | - Bristol |
| | 29 | - Royal Free |
| 23 | | == IT |
| | 42 | == IT Requirements |
| | 43 | |
| | 44 | 1. New online REDCap survey |
| | 45 | 2. Produce paper copy of survey |
| | 46 | 3. Copy of online survey as questionnaire for CAE staff to transcribe paper copies |
| | 47 | 4. Demographics checking for participant mailings at Leicester |
| | 48 | 5. New REDCap questionnaire for deep phenotyping on N3 survey |
| | 49 | 6. Administration and networking set up for external site connections to Deep phenotyping questionnaire. |
| | 50 | 7. Labels for mouth swab samples and associated consent form |
| | 51 | 8. Labels for blood samples and associated consent form |
| | 52 | 9. CiviCRM project for participant management |
| | 53 | 10. Recruitment Report |
| | 54 | 11. Data quality reports |
| | 55 | 12. CAE drive space for medical notes and images |
| | 56 | 13. Data extracts from REDCap and CiviCRM |
