Investigator guide

The study’s completion guidelines from the eCRF: draft, versions, the site’s copy.

The investigator guide (in the industry, CRF completion guidelines, CCG) tells the site team how to fill in the electronic forms of this particular study: which visits, which forms at each visit, which fields are required, which values will not be saved and which will raise a query. It is usually written by hand, and after a couple of eCRF amendments it no longer matches the database. In YouEDC the portal builds the guide from the YouEDC Capture eCRF builder, the data manager adds only what the eCRF does not hold, and once approved the site reads it right in the portal.

The guide’s path: the draft is built from the eCRF, the DM adds their parts, the author signs and another person approves, the PDF goes to the TMF, and the site sees the approved version from a button in YouEDC Capture.

What the portal writes itself

• The patient’s path: the visits with days and windows, for example “day 182 · ±30 d.”, and the “any time” visits (adverse event, unscheduled visit).
• The visit × form matrix: which form is filled in at which visit; forms the patient fills in are marked.
• Every form and every field: type and units, “required”, the allowed range (“allowed from 50 to 300 mmHg, otherwise not saved”), the expected range (“expected from 90 to 180, otherwise a query”), show conditions (“shown only when “Smoker” is “Yes””), whether ND / UNK / NA may be marked, key data and hints.
• Check messages: the exact text the site will see on screen and where it appears. The generic messages are explained on the study’s own fields.
• Adverse events and queries: the steps as pictures, the query statuses, what the site does.
• Changes since the last approved version, with a “material” tag on changes that alter the site’s work.

There is no patient data in the guide: the portal takes only the eCRF structure, so the document can safely go to the site and to the TMF.

The draft guide of the demo study: the cover with figures and the patient’s path of 12 visits.

What the data manager writes

• How to report a serious adverse event and contacts: required, a version cannot be issued without them.
• A welcome and general conventions (date format, rounding, what counts as a source document): optional, there is a standard text.
• A protocol rule for any form, for example “If there are two measurements, enter the mean”. It is shown as a blue box above the form’s fields.

The Vital signs form in the guide: red chips mean the value is not saved, amber ones mean a query opens, blue ones are show conditions. Under the form is the protocol rule box (visible to the DM only).

Versions, signatures and the site

1. The data manager or project administrator opens “DM documents → Investigator guide”, writes the texts and clicks “Issue version 0.1”.
2. The author signs, another person approves (both re-enter their password). The version becomes 1.0, the PDF/A and Word files are kept exactly as signed, and the PDF goes to the TMF inbox, zone 10, artefact “CRF completion guidelines”.
3. The site (investigator, monitor, every team member) sees the “Investigator guide” menu item, a button on the patients page and a link “This form in the investigator guide” on every form. They are shown only the approved version, never the draft.
4. If the eCRF changed, the DM sees “The study changed after the guide was approved” in the menu and a “Changes since version 1.0” section. The site keeps reading the approved version until a new one is approved.

“I have read it”: the training record

Once a version is approved, every investigator and monitor of the study sees a mark in the menu and the button “I have read version 1.0” on the guide page. The portal records the name, role, version, the hash of its content and the time; such a record cannot be changed or deleted. When the new version has material changes, the card says how many, with a link to the changes section. Data entry is not blocked without a confirmation: a study must not stop over an unread document, but the data manager sees who has not read it yet.

How an investigator meets a new approved version: read it and confirm with one button.

The data manager opens the “Training log” (a link on the guide page or in the draft): for each version, every investigator and monitor with their sites and the date of confirmation. The “Send to the TMF” button puts the log as PDF/A into the TMF inbox, zone 1, artefact “Study team training records”.

The training log of the demo study, one tab per approved version.

The A4 card

The “A4 card” button opens one page to print and keep next to the computer: the visit schedule with days, windows and form codes, what the colours of the checks mean, how to report an SAE, contacts, queries and the main rules of data entry. It is built from the same approved version and shows the guide version and the eCRF version. In the draft the data manager can preview the card of the next version.

The card of the demo study. A printout is an uncontrolled copy: the version in force is always in the portal.

eCRF versions

When the eCRF is released in versions, the guide describes the eCRF version in force, not the changes still being prepared in the builder. The cover shows the eCRF version number. A new eCRF version that changes what the site sees makes the guide out of date, and the data manager issues a new guide version.

Sources

• ICH E6(R3): training of site staff and documenting the study’s processes.
• SCDM, Good Clinical Data Management Practices: the chapter on CRF completion guidelines.
• TMF Reference Model: zone 10 “Data management”, artefact CRF completion guidelines.

Blinded studies. The whole site team reads the guide, so the forms “for the unblinded team only” are left out of it; the matrix only says how many there are. Write nothing in the texts about treatment allocation, kit contents or the results of the groups; in a blinded study the draft reminds you. A printout is an uncontrolled copy: the version in force is always the one in the portal.