MoCRA — Adverse Event Ops

Adverse Event Ops

Capture how complaints arrive, where they are logged, who provides medical judgement, and how teams escalate serious cases.

Complaint systems of record

Document the systems where complaints land so you can link each intake channel to its downstream workflow.

No complaint systems documented yet.

Intake channels

Select every intake channel, then document who operates it and where complaints land after intake.

Acknowledgement target

Share the service-level target for acknowledging new complaints and how the team responds.

How fast do you commit to acknowledge new complaints?

Which channel do you use to follow up with complaints?

Do you have after-hours or weekend coverage for acknowledgements?

YesNo

Medical reviewers

Identify the clinicians or advisors who judge severity and timing for FDA submissions.

Add the clinicians or services who supply medical review.

Serious adverse events contacts

Escalate immediately when hospitalizations, life-threatening events, or significant medical outcomes surface.

Add the people who must be paged for serious adverse events so no critical case is missed.

Complaint follow-up

Outline the steady-state complaint triage team for routine issues that still need timely follow-up.

Capture the default complaint escalation chain so every reported issue receives a response.

Trend alerts & spikes

Notify analytics, quality, or operations leads who monitor spikes and coordinate broader responses.

Include the people who analyze complaint spikes so they can jump in when metrics cross thresholds.

Need a hand?

Schedule a call with our team or let Lydra prefill the intake for you.