Informed consent
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 signed originals stay at the site; YouEDC Capture keeps the facts of consent and, when the site files them, the scans of the signed forms, which only the site team and the project administrator open.
Paper or electronic
Every study's consent is on paper by default: the patient signs the form at the site, the site records the consent in the portal and files the scan. At the top of the Informed consent page the project administrator chooses Electronic: remote signing then comes on top of paper — the text of the version to read at home, questions on understanding, the talk with the doctor, the patient's signature with a code and the investigator's countersignature. Paper consents in an electronic study are recorded as before. The study goes back to paper once no link waits for the patient or for the countersignature. Every switch is in the audit trail. Studies that already used remote consent before this version of the portal stayed electronic.
Versions of the form and a basis without consent
Study menu → Informed consent. The project administrator 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.
In the column Documents the administrator attaches to each version the approved form itself (PDF or Word), the ethics committee's approval and other documents. They hold no patient data, and the whole study team opens them. While a form version has no approved document, the column shows a red “no approved form”.
The patient's consent
In the patient's card, Informed consent → Record a consent: the version, the date and time of signing, who obtained the consent (you, by default), who signed — the patient or a legally acceptable representative, whether an impartial witness was present (the patient cannot read), whether the patient got a signed and dated copy, and what else the patient agreed to. The time matters when the consent and the first procedure of the study fall on one day: the consent must come first. Only what the chosen version allows is kept. A version cannot be signed before the site moved to it (see below). Every record goes into the audit trail.
The scan of the signed form
A scan or photo of every page of the signed form can be filed right when the consent is recorded, or later: File a scan under the consent. PDF, JPEG and PNG are taken. The file is named by the patient's code (for example, REG01-01-0007-IC-Version-2-0-1.pdf): the name from the scanner or phone often carries the patient's name, so it is not kept. A photo loses its metadata (place, phone, time taken).
The scan shows the patient's name and signature, so only the team of the patient's site and the project administrator open it. The data manager, the monitor and the sponsor see that a scan is on file, its date and its checksum, never the file. A study can allow monitors the remote check: the box Monitors open the signed copies in the settings block at the bottom of the page (off by default; switch it on only when the consent form tells the patient that monitors see their records). Every view and download of a scan is written to the audit trail: who, when and which file. The portal administrator can take the right to open scans away from a person or a group (the right Informed consent: open the signed copies).
A wrong scan (another patient's, say) is withdrawn with the button Withdraw and a reason: the file is deleted from the server, and the audit trail keeps the record and its SHA-256 checksum. On a withdrawal of consent, the scan of the written withdrawal is filed the same way. The tab No scan on the page shows the patients whose latest paper consent has no scan.
The monitor's check
The monitor compares the record with the original at the site — the right version, the patient's own signature and date, who obtained the consent, signed before any procedure — and presses Checked against the original under the consent (a note is optional). The mark with the name and date is seen by everyone who sees the patient and goes into the audit trail; the top of the page shows how many paper consents have a scan and how many are checked.
Versions at the sites
A new version (a protocol amendment) reaches the sites one by one: each site starts using it after its own ethics committee approved it. Below the versions, the table Versions at the sites holds, for each version and each site, the day the site moved to it and the number of the decision. The project manager fills it and presses Save the days; every change goes into the audit trail with the old and the new day. The day cannot be in the future or before the version's approval. A version can also name the protocol version it belongs to.
A patient of the site cannot sign the version before the site's day: neither a consent recorded by hand nor a remote signature (the link is not sent, and the countersignature is refused). While the site's day is not filled, the portal checks the version's approval date and says that the site's days are missing. If a day is changed later and some consents now come before it, the portal says how many.
Consents and visits by date
In the patient's card, under the consents, Consents and visits by date puts the consents and the visits that took place on one line, each visit with the version the patient had signed by then. A visit done after the site moved to a version asking for re-consent, while the patient had not signed it yet, is marked red, and so is a consent signed before the site moved to its version. Both are offered in YouEDC Trials as deviation candidates (category Informed consent); the monitor decides whether it is a deviation.
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).
Remote signing
When remote consent is on in the portal and the study is electronic, the patient can sign a version at home by a personal link, and the investigator then countersigns. Such a consent is recorded here too, with the mark signed remotely, and follows the same rules. How to add the text of a version, send the link and countersign: the article Remote electronic consent.
The block Remote consent: the talk with the doctor at the bottom of this page holds the study's settings of the talk before a remote signature: whether a talk with the doctor is required before signing (off by default), the letters to the patient about the talk, and the domains of the video services whose links the site may give. The list Remote signing: waiting for the site also shows the talks planned and those to record after they took place.
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.
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