Study profile and portfolio

An optional description of the study from lists, the passport on the overview and the portfolio statistics.

The study profile is an optional description of a study: phase, design, disease, population, countries, timelines, regulatory, endpoints and data sources. Almost everything is chosen from drop-down lists, so profiles can be counted: how many phase III studies you have, in which area, in which countries, when the databases lock. Nothing is required: fill in what you know.

Where to find it

Open the project → Settings → the Study profile (optional) card. The project overview has a Study passport card that links there too. The whole team can read the profile; the project administrator changes it. After the database lock in YouEDC Capture, and in the archive, it is read-only.

Six sections

1. Design: phase, primary purpose, allocation, model (interventional or observational), blinding and who is blinded, control, number of arms, ratio, stratification, how patients are randomised, adaptive design. The terms follow the ClinicalTrials.gov data elements.
2. Disease and treatment: therapeutic area, ICD-10 chapter and the indication's code, type of intervention, product status, route of administration (CDISC Controlled Terminology values, reusable in SDTM later), dosing pattern, tumour response criteria (RECIST 1.1, iRECIST, RANO, Lugano and others).
3. Population: sex, ICH E11 and E7 age groups, minimum and maximum age, healthy volunteers, women of childbearing potential, vulnerable groups.
4. Size, countries and timelines: planned patients and sites, countries, recruitment, treatment and follow-up duration, FPI, LPI, LPO, database lock and report dates.
5. Sponsor and regulatory: sponsor type and country, approvals (Russia, EAEU, EU, FDA, Israel), standard (ICH E6(R2) or E6(R3), ISO 14155), ethics committees, ClinicalTrials.gov and EU CT numbers.
6. Endpoints and data: primary and secondary endpoints, how the primary one is measured, interim analyses, data monitoring committee, data sources, eCRF pages per patient, CDISC standards and dictionaries.

Suggestions from the protocol

The Suggest from the protocol button reads the project's name and description and the protocols analysed in this project by Protocol to study build. It finds words like “a randomised, double-blind, placebo-controlled phase III study” and proposes the phase, allocation, blinding, control and NCT number. It is a word search, no AI. Suggestions fill only empty fields, are marked in blue and are not saved until you check them and press Save. When a study is created straight from an analysed protocol, these fields are filled at once, with “From the protocol …” in the audit trail.

The passport in the project cabinet

The project overview shows a card with how much is filled, the key facts (phase, area, allocation, blinding, control, patients, countries) and a timeline FPI → LPI → LPO → DBL → CSR with today marked.

Portfolio

The Portfolio menu item in YouEDC Capture and YouEDC Studio gathers every project where you are in the team: how many are running, starting and locked, a breakdown by status, phase, area, allocation, blinding, type of intervention, countries and sponsor type, timelines from the first patient to the database lock, and a table of projects. Filters by section, status, phase and area recount the whole page. Archived projects show when you pick the Archived status.

Excel for analysis exports one row per project: labels in your language on the first sheet, the stored codes on the codes sheet (several values joined by “|”) for statistics software. The export is recorded in the portal's audit trail.

What the audit trail keeps

Each save of the profile is one “Study profile” record in the project's audit trail: which fields changed, old and new values. Phase, planned patients, the first patient date and the planned database lock are the same values as in the DM project settings and in the “Database lock dates” widget: change them in either place.