New field (Categories) on S/AE report

[marshalc]

To aide categorisation of S/AE reports for DMC reporting, add the following fields...

(replies coming after train journey following Jan 12th Meeting)

[marshalc]

Categorisation to be done by initial author, with Serious events needing review and authorised check.

Add a check field for {ROLE?} to see and fill in later.

[ij-cope]

As discussed, categories to add to the AE forms. Please place after the 6 questions that define a serious event and before the free text boxes.

Multiple boxes can be ticked for each AE reported

• Kidney dysfunction
• Surgical revision
• Arterial thrombosis
• Venous thrombosis
• Arterial stenosis
• Ureteral stenosis
• Ureteral necrosis
• Permanent graft failure
• Lymphocoele
• Seroma
• Bleeding
• Suspicion of rejection
• Infection Chest
• Infection Urine
• Infection Sepsis
• Infection Wound
• Infection Abdominal
• Cardiac failure
• Myocardial infarction
• Respiratory failure
• CMV infection or reactivation
• Transfusion
• Diarrhoea and/or vomiting
• Malaise
• Electrolyte disturbances
• Device error
• Device user error
• Other

We agreed that all users with access to AE forms would be able to tick these boxes and that for SAEs a validation by the Central Investigator or Central Coordinator would be needed.

For AEs already in the system at time of releasing this update, we agreed the Central Coordinator would add the categories.

[marshalc]

Actions

1. Create new class in AdverseEvent to hold these categories (and allow for editing/expansion)
2. Create a fixture file with the above set of data in to do initial population of category data
3. Add a many-to-many field on adverse_event.AdverseEvent to link to these categories
4. Modify the S/AE forms and views to process this new addition

[marshalc]

1. Class created
2. Data populated via Fixture
3. Event has new Categories field

Todo:

4. Modify the S/AE Form display

[marshalc]

S/AE Form display updated, with Administrators now able to add Categories to the Events