Patient casebook (PDF)

A certified copy of a patient's data with the queries and the audit trail; the casebooks of a site in one zip for the archive.

The casebook is a certified copy of one patient's data in a single PDF: every form with the values as entered, the queries with their whole conversation and the patient's complete audit trail. The site keeps it in its investigator site file, it goes to the archive, and an inspector can read it without access to the system.

The casebook of patient REGDIA-01-0001 of REG-DIAB-01: three parts, the same footer on every page and the data file embedded in the PDF.

Making a casebook

Open the patient card and press Casebook PDF at the top right. The PDF is made from the database at once and downloads with a name like REG-DIAB-01_REGDIA-01-0001_casebook_2026-10-04_1349.pdf.

• Who: the project administrator, for every site; the data manager, the investigator and the monitor, for the sites of their membership, or for every site when their membership is not limited to some sites.
• Audit trail: every casebook made is recorded as “Casebook (certified copy)” with the SHA-256 of its data.
• Limits: the Portal Owner can switch the function off and limit how many casebooks one person makes per day.

What is inside

The file is a PDF/A-3, the archival kind of PDF.

The cover

• the study, the site, the patient ID, sex and year of birth, the enrolment date and the status;
• the eCRF version in force;
• who made the copy and when, and the SHA-256 of the data;
• the certified copy statement;
• how many forms, queries and audit records the casebook holds;
• the signatures of the patient's record, if there are any.

The cover: the study, the site and the patient, the eCRF version in force, who made the copy and when, the statement and the counts: 7 forms, 1 query and 43 audit records.

Visits and forms

Each visit and each form, with the values as entered:

• answer options as their labels with their codes, numbers with their units, and the “no data” marks ND, UNK and NA;
• the form status (draft, complete or SDV verified), who saved it and when, who verified it and when;
• the eCRF version the form was saved under;
• deactivated forms and fields, only where they hold data, marked “deactivated”;
• tables as tables: the row, the values of the columns and the row’s unit; below them, the deleted rows of a growing table, who deleted them, when and why.

Queries

Under each form come its queries with the whole conversation: who wrote what, and when. For example, on page 3 of the casebook of REGDIA-01-0001, under the form Drug therapy of the Month 6 visit, comes the open query Q-0004 on CM_DOSE, the daily dose: on 29.09.2026 the monitor Igor Smirnov wrote “The date does not match the visit date in the outpatient record.”

Page 3: the forms of the Month 6 visit with the values, their codes and units; each form’s status, who saved it and when, the SDV and the eCRF version it was saved under; and the query Q-0004 under the form Drug therapy.

The audit trail

At the end comes the complete audit trail of the patient: number, time, who, event, where, before, after and reason.

On every page

The study, the patient, “Certified copy”, the page number (N / M) and the SHA-256 of the data.

A certified copy

ICH E6(R3) accepts a copy as a certified copy when it keeps the content and meaning of the original and is verified by a dated signature or made by a validated process. The casebook is made by the system automatically from the database, without manual steps, and every copy made is recorded in the audit trail with the hash of its data, so it can always be traced to who made it and when.

Checking a printout against the file

The PDF carries the file casebook.json as an attachment: the same data as codes and values, the queries, and the audit records with their hashes. Its SHA-256 is the one printed on every page, so anyone can check a printout against the file:

Checking a copy needs no access to YouEDC: only the PDF and a tool that computes SHA-256.

1. Open the attachments of the PDF (every PDF reader shows them, often behind a paperclip icon) and save casebook.json.
2. Compute its SHA-256: on Windows certutil -hashfile casebook.json SHA256, on macOS and Linux shasum -a 256 casebook.json.
3. Compare the result with the SHA-256 at the bottom of the pages. The same value is in the audit record of that casebook.

The casebooks of a whole site

At study close each site keeps its own copy of its patients' data in its site file: the sponsor must not be the only one who holds it. All casebooks of a site are made at once:

1. On the patient list, press Casebooks.
2. Choose the site, for example “01 · City Hospital 1, Endocrinology”, and press Make the casebooks.
3. The casebooks are made in the background. The zip appears in My background jobs (in your profile); if mail is set up, an e-mail tells you when it is ready.

The casebooks of site 01 in one zip: a PDF per patient, MANIFEST.csv to check every file, and README.txt.

The zip holds one PDF per patient, MANIFEST.csv (each file, its patient, the SHA-256 of the PDF and the SHA-256 of its data) and README.txt. The rules are the same as for one casebook: only the sites of your membership, and every casebook is recorded in the audit trail.

The site close-out copy prepared in the Trial Master File also carries the site's data: Excel, CDISC ODM and the audit trail of the site's patients.

When the server cannot make PDF

If the PDF library is missing on the server, Casebook PDF opens the print view in the browser instead: print it to PDF from the browser. The casebooks of a whole site cannot be made then: the server says so and suggests printing each patient's casebook from the browser.

Make the site copies after the database lock. Then the casebooks hold the final data, and the SHA-256 on every page identifies exactly the copy the site received.