EDC for postpartum depression clinical trials

Postpartum depression studies cover several designs: drug trials with a short treatment course, psychotherapy and peer-support trials, digital programmes, and prevention studies that enrol women during pregnancy and follow them after delivery. They share one unusual feature. The index event is not a diagnosis date but a birth, so almost every window in the protocol is counted from delivery, and the baseline form has to carry the delivery date, gestational age at birth, mode of delivery and obstetric complications. Without these, eligibility (for example onset within a stated number of weeks of delivery) cannot be checked by a monitor.

The primary outcome in many registered trials is the change in a depression score. The 10-item Edinburgh Postnatal Depression Scale, scored 0 to 30, is a common self-report measure, and registered protocols use cut-offs of 10 or 13 and sometimes a change of several points as a meaningful response. A 2020 individual participant data meta-analysis found the best combined accuracy near a cut-off of 11, with lower cut-offs more sensitive and higher ones more specific. The cut-off is therefore a protocol decision, and the EDC should store the total score, the individual item responses and the date, so the analysis can apply whichever threshold the statistical plan names. Clinician-rated scales such as the Hamilton or MADRS (see the Hamilton Depression Scale template) go on a site form with the rater recorded.

Instruments are other people’s work. Capture does not supply licensed wording; the study team holds the licence and files it with the study documents. Participant questionnaires can carry licence number, holder and expiry in the app, and nothing is blocked while those are missing, so the discipline of checking terms stays with your team. For the structure of a depression form, the PHQ-9 template and EDC for major depressive disorder trials show how a score, severity band and item responses sit together.

Safety in this population has its own shape. Depression trials routinely monitor suicidal ideation, and many protocols use a structured scale such as the C-SSRS (the C-SSRS template shows the form structure). Self-report depression questionnaires are also commonly reviewed for an item about self-harm. Decide in the protocol who sees a flagged answer and how fast. An edit check in Capture raises a query for site review, which suits data cleaning, but a query is not a clinical alert. The urgent pathway, a phone call to the participant, belongs in the study procedures, and the EDC form should record that it happened.

For drug trials, sedation, dizziness and somnolence matter more than usual when the participant is caring for a newborn at night, and the AE form should capture onset, grade, relationship and any action on the study drug as separate answers. Keep severity, seriousness and causality as separate fields; the AE causality assessment page and the AE seriousness decision tree explain the split. Serious events follow the SAE report form, and the SAE reporting deadline calculator helps plan clocks.

Ethics committees often ask what happens when a mother stops answering. Reminders on the questionnaire help, and the compliance view shows by site who is overdue, so a coordinator can phone before the visit window closes. The reminders themselves are described under ePRO compliance and reminders.