Consentement éclairé

Consent versions and their scope, the patient's consent, re-consent, a basis without consent, the two kinds of withdrawal.

A registry or an observational study collects data only with the patient's consent, and over years of follow-up the informed consent form changes. In YouEDC Capture a study keeps the versions of its consent form, and each patient keeps when they signed, which version and what they agreed to. The portal stores no names and no signed copies: the originals stay at the site, YouEDC Capture keeps only the facts.

Versions of the form and a basis without consent

Study menu → Informed consent. The project manager adds a version: its number, the date the ethics committee approved it, and what the form allows besides taking part and the processing of the data — linking with medical records, contacting the patient again, secondary use of the data. When everyone who signed an earlier version must sign the new one, tick Patients on earlier versions sign this one.

For a retrospective study, add a Basis without consent instead: the number and date of the ethics committee's decision that allowed collecting the data without asking each patient. As long as a study has no version, it keeps no consents and nothing is blocked.

The patient's consent

In the patient's card, Informed consent → Record a consent: the version, the date of signing, who obtained the consent (you, by default) and what else the patient agreed to. Only what the chosen version allows is kept. A version cannot be signed before it was approved. Every record goes into the audit trail.

Re-consent

Once a version asking for re-consent is added, patients on earlier versions are marked Re-consent needed — in the card and on a tab of the consent page. The mark goes once the new signature is recorded. Data entry does not stop meanwhile: the consent to the earlier version stands until the patient signs the new one or refuses.

Data entry only after consent

A setting at the bottom of the consent page, on by default. The forms of a patient without a consent that stands (none recorded, or withdrawn) open read-only, and the patient's ePRO link takes no answers. For a retrospective study with a basis without consent, record that basis for the patient and entry opens.

Withdrawal of consent

In the card → Withdrawal of consent, two kinds:

• Stops taking part; the data collected stays in use — the patient gets the status “Withdrawn” from the date of withdrawal, and no new visits are planned.
• Stops taking part and the use of the data — besides, the patient's data leaves every export (Excel, CSV, CDISC ODM). The portal deletes nothing on its own so that the audit trail stays whole: the collected data is destroyed following your organisation's procedure under the law (in Russia, 152-FZ).

In the export and the certified copy

When a study keeps consents, the Excel export gets a Consents sheet and the CSV export a consents.csv file: every consent of every patient with the version, the date, the scope (RECORDS, RECONTACT, SECONDARY — Y/N) and the withdrawal. The statistician selects the patients who agreed to secondary use by these columns. The patient's certified casebook holds all their consents and withdrawals.