EDC for geroscience drug-repurposing trials

A daily pill is easy to record. A weekly dose, a dose taken for a few days each month or a protocol with a titration step is harder, because the question "did the participant take what was prescribed?" depends on the schedule. The cleanest approach is to record each scheduled dose as a row with the planned date, the actual date and a coded reason for any difference. Capture supports repeating table rows on eCRF forms, each with its own audit trail, and participants can complete the same questions in a short phone diary with reminders. A calculated field turns the rows into an adherence figure, and an edit check raises a query when a dose is recorded outside your protocol window.

Titration and dose reductions for tolerability should be explicit events on the form, not a note. Record the new dose, the date and the reason, so the analysis can handle dose changes consistently. If the protocol has stopping rules, put the stopping criteria on the form that the investigator completes, so a decision to stop is tied to the evidence for it. The IMP inventory and drug accountability page covers the supply side: kit dispensing, returns and counts.

The safety profile of a known drug does not transfer automatically to a new population or a new schedule, so these studies typically schedule safety labs on a regular basis and screen concomitant medications carefully. In Capture, lab forms store analytes with a unit, result and reference range, and edit checks can raise an auto-query when a value crosses a protocol limit. The AI lab-table drafting feature can read a lab sheet or a CSV and propose the analyte rows, which you review before anything is saved; see lab data and reference range management for how ranges are stored.

Interactions are a data problem as much as a clinical one. A repeating concomitant medications table with start and stop dates lets the safety reviewer see what else a participant took during any adverse event. Use the concomitant medications template as a base. Adverse events go on the adverse event form with an SAE workflow and field-level audit trail. Capture is not a pharmacovigilance safety database; use a dedicated one for case processing and regulatory safety reports if you need it. See adverse event reporting software.

Using an approved drug for a new purpose usually still requires regulatory and ethics review, and the requirements differ by country and by the study's design. This page is not legal or regulatory advice. Check the rules that apply to your study with your regulatory adviser and ethics committee, and write the protocol to that standard. Capture provides 21 CFR Part 11-aligned controls (field-level audit trail, role-based access, electronic signatures) and the sponsor is responsible for validated use. Before submitting to a committee, you can export a blank eCRF PDF with a cover page, form index and visit-by-form matrix; the IRB submission checklist lists what else committees often ask for.

If the study is small and exploratory, begin with a pilot. How to run a pilot study explains how to scope one so the data set-up you test is the one the larger study uses.