Pregnancy Follow-Up and Outcome

Handle a pregnancy exposure case and obtain birth outcome per GVP and company process.

Role: PV Case Manager

Context: A pregnancy case was reported 6 months ago (exposure to your drug in first trimester). You have not yet received birth outcome.

Task: Apply correct follow-up and closure practice.

Step 1 of 2

Follow-Up Strategy

case

The reporter was the patient's GP. Last contact 4 months ago; no outcome received.

What do you do?