Investigator cards
What a card keeps, document expiry, the card file, clinomir.ru and personal data.
An investigator card is one record of a person your organisation works with: a principal investigator, sub-investigator, coordinator or pharmacist. It is entered once and used in all the organisation's studies. Only the people of your organisation see it (Organisation and people, in the site directory).
What a card keeps
- The basics: the full name as in the documents and in English for a CV, the usual role, specialty, degree, position, languages, work e-mail and phone.
- Sites: workplaces from the site directory with the position and years.
- Documents: CV, GCP certificate, specialist accreditation, IATA training, licences and others, with the date, expiry and file (PDF, JPG, PNG or DOCX up to 10 MB).
- Education and work: university, residency, degree, positions: the lines of a CV.
- Experience in studies: protocol, phase, sponsor, permit number, role, years and the patients enrolled.
The readiness bar shows what is missing of what a sponsor asks first: the specialty, a workplace, a CV signed within 2 years, a valid GCP certificate and experience.
Document expiry
When a document has an expiry date, that date counts. Otherwise it is counted from the issue date by the usual rule: GCP 3 years, CV 2 years (from the signature), accreditation 5 years, IATA 2 years. No law sets these terms; sponsors do, and a sponsor may ask for less. A document within 90 days of its end is marked "expires soon", and the list of investigators shows all such documents of the organisation on the right.
A new CV, GCP certificate, accreditation or licence replaces the previous document of its kind. The old one is not deleted: it stays under "Other and earlier documents" with its file and SHA-256, so what was valid on a day can be shown. A document is removed only with a reason, which goes to the audit trail.
Experience in studies
The experience does not have to be typed in full. There are three ways:
- From your studies. When a study of the organisation names a site's PI with the same surname, the portal suggests it with "It is this person". You confirm, and the row is added with the code, phase and the site's patients.
- From a page on clinomir.ru. Paste the link of a study page like
https://clinomir.ru/trials/12969/. The portal reads only that page of the open permit registry: the protocol, phase, sponsor, permit number and date, years. You check, correct and give the role. The row keeps the link and the day it was read. - By hand, for studies found in neither.
The card file
"Card file" downloads the card in the open youedc-investigator-card format (JSON): the basics, sites, documents without files, education, work and experience. Contacts and the legal basis are not included: they are your organisation's own.
An investigator can bring such a file from another organisation on YouEDC or from any system that writes it. Load it under "Load the card file": the portal shows all it read and saves nothing until you have checked the card, filled in the contacts and the basis, and confirmed that the person gave you the file. Sites not in your directory are not linked: add them to the directory, then to the card.
clinomir.ru and personal data
clinomir.ru shows study and site pages from the permit registry, while investigators' profiles are closed, and its user agreement forbids collecting other users' data. So the portal takes only facts about a study from clinomir.ru, and only from the one link you pasted. It obeys the site's robots.txt and reads nothing about people.
A card is personal data (152-FZ, GDPR). Keep only what a sponsor needs to select and activate a site. Never enter a passport, SNILS, health data, bank details or fees. Give each card its basis (consent, contract, study agreement) and the document. When the basis ends or the person asks, an organisation admin deletes the card with all its documents, files and experience. The audit trail keeps only the card number, what was done and why, without contacts or document contents.