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Clinical records

Record hospital stays and clinical events such as surgery, procedures and complications per EnaResearch participant, with history and entered-in-error marking.

Applies to:
  • Admin panel
Last updated: Verified with EnaResearch 0.15.0

Clinical records put measurements into clinical context. The study team records each participant's hospital stays and clinical events (surgery, procedures, critical care, ward transfers, follow-up visits, complications) with structured fields. Variables, datasets and the dashboard can then use these records as anchors, for example "mean heart rate in the 24 hours before surgery".

Required role

  • Reading: any member of the study team.
  • Adding and correcting: a team member with participant management permission (owners and researchers).
  • The study must have a Clinical record scope. Entries are possible while the study is open, including its late data window; not after it is closed.

Clinical record scope

The scope is chosen in the study wizard (Data scope step) from these categories: Hospital stay, Surgery, Procedure, Critical care, Ward transfer, Follow-up, Complication, Other. Clinical records are health data: the ethics approval and informed consent must cover them. After approval, the scope changes only through a change request.

Add a hospital stay

In the participant panel → Clinical records, click Add stay:

  • Stay type: Inpatient stay or Day case.
  • Admission and Discharge. Leave the discharge empty while the stay is ongoing. Tick Only the day is known if the exact time is unknown.
  • Note (optional).

Stays of the same participation cannot overlap.

Add a clinical event

Click Add event and choose the Event type:

CategoryEvent types
SurgerySurgery
ProcedureBronchoscopy, Biopsy, Chest tube, Other procedure
Critical careICU stay (one record from admission to discharge)
Ward transferWard transfer
Follow-upOutpatient visit, Follow-up assessment
ComplicationPneumonia, Air leak, Wound infection, Other complication
OtherOther

Then fill in Status (Planned, Completed, Cancelled), the time (Start and End, or a single Time) and, depending on the type, Details:

  • Surgery: Surgical approach, Anatomical site, Intent, Urgency, Anesthesia, ASA class, Outcome, Operative context (index operation, planned staged, unplanned return to the operating room) and Operator role. Surgeons' names are not recorded, only their role.
  • Procedures: anatomical site, intent and outcome.
  • Complications: Clavien–Dindo grade.

Under Links and note you can attach the event to a Stay, mark a procedure as Part of surgery, and link a Related event with a Relation (Complication of, Re-operation for, Follows). "Other" types need a name.

Times are when the event happened, separate from when you entered it. A completed event cannot be in the future.

Correct a record

Click the record → Edit, change the fields and enter a Reason for change (required). Every change keeps a full copy of the record; open its History to see each version, who made it and why. Datasets read the record as it stood at their data cutoff. Note text is not kept in the history; the history only shows that the note changed.

Mark as entered in error

Records are never deleted. If a record was entered by mistake, choose Mark as entered in error and give a reason. The record stays in the audit log with the reason, is left out of exports and variables, and cannot be edited afterwards.

No identifying details in notes

Do not write names, ID numbers or record numbers in clinical notes. Notes are left out of exports by default and their text is not written to the audit log.

Participants never see clinical records, in the app or on the web.

Can't find what you need?

Our support team can help, from setting up a study to exporting a dataset. Please include your organization code.

support@enainnovation.com · 0850 308 45 91