Research Data Management for Small Teams: Cases as Study Records

A research group is a small organisation with unusually demanding record-keeping. Consent forms that must be findable for a decade. Participant details that must be separated from the data they produced. Amendments to protocols that must be dated. Funders who ask, at the end, exactly what was collected and where it went.

A lab notebook does the science. Something else has to do the administration.

One case per study, sub-cases per participant or site

A study case holds the protocol, the ethics approval and its amendments, the funder correspondence, the team in their roles (principal investigator, co-investigators, research assistants, data manager). Beneath it, sub-cases per participant or per site hold consent forms, contact details and the schedule of visits — with roll-ups so the study case shows how many are enrolled, withdrawn and complete without opening any of them.

Separating identity from data

Herarx is not where your dataset lives; it is where the records about the dataset live. Keep participants' identifying details in their sub-case under Advanced Security — encrypted with the case's own key, invisible to anyone who is not a member — and keep the pseudonymised study ID as a plain field the rest of the team can see. The link between the two exists in exactly one place, and that place is locked.

Consent that can be found

Consent forms go in as files on the participant's case, or are collected through an e-sign request so the signed form, the verification of the signer's email and the timestamp arrive together. Re-consent after a protocol amendment is a new request against the same case; the versions sit side by side.

The schedule

Visit dates, follow-up windows and data-lock deadlines are tracked dates on the template, so the calendar shows the whole study. A rule can create a task before each follow-up window closes. When a participant withdraws, a status change on their sub-case updates the roll-up on the study.

Polls for the committee

Small decisions — meeting dates, which of three analysis plans to pursue — do not need a meeting. A poll from the case goes to the team, with a deadline, and the result is recorded on the case rather than in someone's inbox.

At the end

The data management plan asked for a description of what was collected, where it was kept and when it will be destroyed. The study case is that description. Export the timeline, list the files, note the retention date, close the case — and let the review rule ask, ten years on, whether it can go.