Safety and outcomes
Adverse events graded and coded as they are recorded
Grade adverse events to VCOG-CTCAE v2 inside the form, code them to VeDDRA in a review queue, and measure response with the criteria your protocol names.
Adverse events graded to VCOG-CTCAE v2
Adverse events are recorded on the study’s standard form against VCOG-CTCAE v2, so each one carries a term and a grade from the moment it is entered. Serious events go on to an SAE report from the same record.
- Graded inside the form, not in a spreadsheet afterwards
- Serious adverse event reports from the same record
- A note when the species is not a dog or a cat, which the criteria were written for
Coded to VeDDRA, approved by a second person
Once a form is complete, each adverse event term waits in the study’s coding queue. ARC suggests a VeDDRA term from the study’s own synonyms and from exact matches; a coder accepts or chooses another, and a second person approves.
- VeDDRA comes with ARC: nothing to load or license
- ATCvet for medications, once your organization holds a licence
- Codes travel with every export, in their own file
- Each code, change and approval is in the audit trail
Response by the criteria your protocol names
One evaluator for cRECIST v1.0, irRECIST and VCOG peripheral nodal lymphoma response, with every threshold a named setting. Best overall response and the date of progression are worked out for each patient.
- Lengths measured in the imaging viewer are recorded straight to response
- Every threshold is a documented setting, not a hidden constant
Survival and time to event, checked against R
Time-to-event endpoints and Kaplan–Meier estimates are computed in ARC, and every build checks them against R’s survival package to within a billionth. Follow-up after treatment records each contact, retry and loss.
- Follow-up with contacts, retries, lost to follow-up and deaths
- Owner surveys sent during follow-up
Pictures show fictional studies.
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