Help desk

Ask in your own words, why can't I, questions to the study team and to YouEDC support, urgent security questions, the knowledge base.

The Help button in the top bar of every page opens the help desk. It works like a ladder: first the portal tries to answer by itself, then it tells who in the study can help, and only then a question reaches YouEDC support. The buttons to write to a person are there from the start: you do not have to climb every step.

Ask in your own words

• Write the question as it is: “how to add an unscheduled visit”, “why can’t I see a patient”. The portal shows the parts of the help that answer it, with a link to the right section of the article.
• Answers marked Answered before come from the knowledge base: support’s answers to the same questions of other people.
• Below the answers are Ask the study team and Write to YouEDC support: what you looked for goes with the question if you keep it.
• Further down the same panel is the article about the page you are on.

Why can’t I…

On a study page, Why can’t I… shows your role, the sites open to you, the study’s stage and whether you see the treatment allocation. Then a list of usual actions: enter data, enrol a patient, answer a query, sign, export and others. For each: whether you can, why not, and who can change it.

• When the role does not allow it, the project administrator can change it (they set roles and sites).
• When a rule for the person or a group took it away, the Portal Owner can change it.
• When the stage stops it (enrolment closed, soft lock, database lock), the project administrator decides.

The answer comes from the same checks that refuse the action, so it always matches what the portal does. Ask the project administrator opens a question to the team about access.

I cannot sign in

The I cannot sign in link is on the sign-in page and works without signing in. It goes through the usual reasons: a wrong password, too many attempts, a letter that does not come, waiting for approval, the code from the e-mail, a company account, a closed network. The guide looks nothing up by address, so it tells nobody whether an account exists.

A question to the study team

• Questions about the protocol, what to enter, access, unlocking or correcting saved data are for the study team, not for the portal’s vendor. Such a question goes to the project administrator and the data managers and stays in the study: YouEDC support does not see it.
• The team answers in the study menu Questions to the team (a red number shows how many wait). There the project administrator fills in the Support of the study: who answers, the hours and a phone for what cannot wait. Every member sees these contacts in the help desk.
• When the question turns out to be about the portal itself, the team presses Pass to YouEDC support with its note.
• The answer comes by e-mail and stays in “My suggestions”, under “Questions to study teams”. You can add to the question or close it there.
• A serious adverse event or an emergency unblinding never goes through the help desk alone: the study has its own procedure and phone for them.

A question to YouEDC support, and urgent ones

• A question about how the portal works, or about something that breaks, goes to YouEDC support. Choose how much it gets in your way: only me, my site or team, data cannot be entered.
• The portal offers diagnostics: the page, the study with your role and its stage, the portal version, the browser, the error number, what you looked for. You see every part and can untick it. The values of form fields never go into the diagnostics.
• Urgent: security or personal data goes straight to the Portal Owner, past every step, with an URGENT letter. A leak of personal data must be reported within 24 hours under 152-FZ, so urgent questions come first in the Portal Owner’s list with the hours counted.
• The “Something went wrong” page now shows an error number and a Report this error button: the question opens with the number that finds the error in the server’s log.

Personal data

• The help desk is about the portal, not about patients. Name a patient only by their number in the study.
• Before a question goes, the portal looks in the text for what looks like personal data: a full name, a date of birth, an insurance or passport number, a phone. If it finds one, it asks you to remove it or confirm there is none. It is a hint, not a guarantee.
• The help desk takes no screenshots (the light bulb has them, with its own warning).
• The text of questions is not written to the audit trail: only the facts are (sent, answered, passed on, closed).
• The help desk has no AI, and nothing is sent outside the portal.

For the Portal Owner: answers and the knowledge base

• Help desk questions come to “Administration → Suggestions” marked Help desk with how urgent they are; the “Help desk questions” filter shows only them. Answer on the portal with “We answer”: the author gets it at once, without a package or a release.
• A good answer becomes a knowledge base entry with one button, Add to the knowledge base: the help desk finds it for the next person. The author’s name is not kept there.
• The Knowledge base and errors page has every entry (each can be switched off), the promise about answer times (shown next to “Send”; promise only what one person can keep) and every error page with its number, even when nobody wrote about it.