Document for the medical record

The registry visit printed as an examination note for the patient's medical record: the doctor fills the visit once and signs the printout by hand.

In real-world studies and registries the doctor first writes the visit into the hospital system and then types the same into the registry. The document for the medical record turns this round: the doctor fills the registry visit once, and the portal prints it as an examination note for the patient's paper medical record. The doctor checks it, writes in the patient's name and signs it by hand.

How to print

On the patient card, under each visit with data, press Document for the medical record (PDF). The PDF opens at once: A4, ready to print. The site's investigators print it for the patients of their sites; the project administrator can print it for any site. When the server cannot make PDF, the same page opens in the browser, and the browser prints it.

What is in the document

• The site, the study code, the visit and its date: the date given on the patient card, else the date most of the visit's date fields hold.
• The title of the visit: “Examination note” unless the study chose another one for this visit, for example “Discharge summary”.
• Empty lines for the patient's full name, date of birth and medical record number: the portal never stores full names, so the doctor writes them by hand. The study patient number is printed small.
• The visit's forms as readable sections: the label and the value with its unit, tables as tables. Empty fields, texts for the investigator and files are left out. A “no data” mark is printed with its reason, and the reason for an unscheduled visit is printed under the title.
• The records since the previous visit, a line each: adverse events, concomitant therapy and other events dated after the previous visit and up to this one.
• The doctor's line for the name, signature and date, and the SHA-256 of the content at the foot. The same content is embedded in the PDF as visit-note.json.

The forms for the unblinded team (the kit contents) are never printed, whoever prints: a blinded patient's medical record must not name the treatment. The randomisation arm is not read at all.

The study's settings

On the Patients page, Medical record document (the project administrator and the data managers) chooses which forms go into the document, whether the records since the previous visit are added and the title of each visit. Without settings every form is in, with the records, under “Examination note”. The study can switch the document off for the site team: then only the project administrator prints it, to check how it looks.

Why it is signed by hand, and the audit trail

The printout becomes a medical document when the doctor signs it. An electronic medical document would make the portal a medical information system with the doctor's qualified e-signature, so stage 1 is paper on purpose, and the note at the foot says so. Every printed document goes to the audit trail with the patient, the visit and the SHA-256 of its content; changing a setting goes there too, with the old and new values.