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Ce qui est fait et ce qui arrive

Nous mettons cette page à jour au fil du travail. Mise à jour : 2026-10-11.

Terminé

Portail : le socle

La nouvelle plateforme sur PostgreSQL à côté de YouEDC 0.2 : comptes, projets, équipe, audit, administration.

21 sur 21 faits

Inscription, connexion, réinitialisation du mot de passe, e-mails Portail
Interface en russe, anglais et français Portail
Bureau DM : ce qui attend une décision aujourd’hui, et recherche dans le portail Portail
Études, centres, équipe, rôles, invitations YouEDC Capture
Piste d’audit chaînée avec contrôle nocturne et export CSV YouEDC Capture
Un seul mécanisme de projets : recueil dans YouEDC Capture ou travail DM dans YouEDC Studio, même équipe, rôles et audit Portail
Administration : fonctions, limites, qui utilise quoi Portail
Accès à chaque fonction : règles personnelles et de groupe, nouveaux comptes approuvés par un administrateur Portail
Sign-in with the company account (SSO, OpenID Connect or SAML 2.0) for CROs and sponsors: the company's own second factor, password sign-in can be closed for its domains Portail
Inspectors and auditors: read-only access until a set day, no files out, the team sees the pages they open; a signed access review every few months and unused accounts closed Portail
Two-step sign-in: a code from the e-mail or from an authenticator app (TOTP) with recovery codes; a project's owner can ask it of the team Portail
Confirmation de l’e-mail à l’inscription, protection contre les robots sans service externe, suppression définitive ou anonymisation avec piste d’audit conservée Portail
E-mails à l’image du portail en trois langues, notifications, rappels uniquement avec consentement et désinscription Portail
Une rubrique « Nouveautés » : un article par version avec tout ce qu’elle contient, et un lien vers le dernier numéro sur le bureau Portail
A short weekly “What’s new” letter: by choice, only in weeks with updates, a one-click unsubscribe Portail
Éditeur des pages du portail en trois langues, avec versions et audit Portail
Kit de validation (UAT/PQ) : scripts, étude de démonstration, chaque étape enregistrée, signature et rapport Portail
Un projet de démo en un clic : une étude de phase III au choix (diabète ou hypertension) avec des données fictives dans chaque section (Capture, Safety, Studio, TMF), des mois d’historique, supprimée en une étape Portail
Profil d’étude à partir de listes (phase, plan, domaine, population, pays, calendrier), un passeport dans le projet et un portefeuille avec graphiques, calendrier et export Excel Portail
A “Suggest to the developer” button on every page: text and screenshots, the page and the study recorded by themselves; the admin sees every suggestion with its author, sets its status and exports them Portail
Help desk before a living person: a question in your own words answered from the help and the knowledge base, “Why can’t I…” from the real checks of the role and the stage, an “I cannot sign in” guide, study questions to the study team, portal questions to YouEDC support, an urgent way for security and personal data, a number on every error page Portail

En cours

YouEDC Capture : tout ce que fait YouEDC 0.2

Les fonctions de 0.2 sont déjà ici. Il reste quelques points et le transfert des études avec leurs données.

84 sur 94 faits

Constructeur eCRF : visites, formulaires, 17 types de champs (date partielle, heure, échelles et EVA, IMC et âge calculés), contrôles, aperçu YouEDC Capture
Patients, matrice des visites, saisie avec contrôles, historique de chaque valeur YouEDC Capture
Queries (automatiques et manuelles) et SDV par formulaire YouEDC Capture
Questionnaires patients (ePRO) par lien personnel, sans compte YouEDC Capture
ePRO: sign-in with a QR code and a PIN, the patient’s leaflet, one question per screen, a review before sending, the time and device of every answer YouEDC Capture
ePRO: e-mail reminders the patient switches on himself, and the site’s adherence board YouEDC Capture
ePRO: a screen pack for the ethics committee in PDF, and time travel for test patients YouEDC Capture
The patient sees their own data in ePRO: the study picks up to six variables, the investigator approves each patient, only checked values with dates are shown, with no norms, colours, comparisons or treatment arm YouEDC Capture
ePRO, stage 2: an event diary, diary hours, the patient’s progress, scale mode with a passport and locked texts, questionnaire scores, the free NRS and VRS formats in the library YouEDC Capture
Actions on event: an if-then rule on a saved form sends the patient a questionnaire for the days set or opens a query to the site, and withdraws itself when the condition stops holding YouEDC Capture
ePRO as an app on the phone without a store: the questionnaires of the coming week without the internet, answers encrypted and sent by themselves, notifications on the phone YouEDC Capture
ePRO by SMS: the invitation and the reminders with the patient’s consent recorded by the site, through the portal’s SMS gateway; the number encrypted and masked, no PIN and no study in the text, quiet hours, limits, a delivery log and the audit trail YouEDC Capture
Free validated questionnaires in the form library: the PHQ-9 and GAD-7 word for word from the official English version, with the scale passport, the total and the severity band, a query to the site on a positive PHQ-9 item 9 and the mark “English only” in a study in Russian YouEDC Capture
ePRO, next: the quality radar, scores in SDTM QS, more free scales in the library and the official Russian versions of the PHQ-9 and GAD-7 YouEDC Capture
ePRO on the site’s tablet: kiosk mode, pairing by a one-time code, the handover from the patient’s card, only their questionnaires, auto-lock and an audited handover YouEDC Capture
ePRO, stage 3: the builder says who answers a questionnaire (the patient, the patient or a representative, a representative only); a parent or a caregiver answers by their own link and PIN; the site enters the answers of an interview by phone or at the visit; every answer says who gave it and who entered it, in the form, the audit trail, the export and the casebook YouEDC Capture
Randomisation : minimisation, blocs stratifiés, liste du statisticien, simulateur, deux signatures, aveugle, levée d’aveugle en urgence, recalcul YouEDC Capture
Import CSV et Excel, exports Excel, CSV et CDISC ODM 1.3.2 YouEDC Capture
Migration from another EDC in a CDISC ODM 1.3.2 file: the eCRF from its metadata, matching by OID, a dry run, a load with the old system's audit records, a migration report into the TMF YouEDC Capture
Les EI graves saisis arrivent d’eux-mêmes dans YouEDC Safety YouEDC Capture
Le plan de validation des données (DVP) s’écrit seul depuis le constructeur eCRF : cas de test UAT, versions, signatures électroniques, PDF/A dans le TMF YouEDC Capture
Le guide de l’investigateur s’écrit seul depuis l’eCRF : parcours du patient, matrice des visites, champs et contrôles, versions, signatures, PDF/A dans le TMF ; le centre le lit d’un clic dans YouEDC Capture, confirme « J’ai lu » (registre de formation dans le TMF) et imprime une fiche A4 YouEDC Capture
Études en aveugle : formulaires réservés à l’équipe non aveugle, leurs données cachées aux membres en aveugle partout, des visites aux exports et à la piste d’audit YouEDC Capture
Signature électronique de l’investigateur (21 CFR Part 11) : patient entier ou chaque visite, mot de passe à la signature, dessin facultatif, une modification retire la signature YouEDC Capture
Lock of single forms: the data manager locks saved forms one by one or many at once by a filter (e.g. for an interim analysis); nobody changes their data, queries, SDV and signatures go on; unlocking with a reason, all in the audit trail YouEDC Capture
A note on a field without a query: the site, the monitor or the data manager explains a value and nobody has to answer; the data, SDV and approval stay, a note is withdrawn with a reason, all in the audit trail, the export and the casebook YouEDC Capture
Remote SDV by copies of source documents: the site uploads copies without personal data, the monitor verifies the visit from the office, the copies are deleted after SDV or by the study's limit, the record stays in the audit trail YouEDC Capture
Bulk data change requests (DCR): the data manager prepares one change for many records, the sites confirm their records as a batch against the source documents or reject them with a reason, all in the audit trail YouEDC Capture
Visit reminders to the patient by SMS or e-mail: the dates of the window only, no personal data, through the ePRO channel YouEDC Capture
Data entry without the internet on one's own device: encrypted forms go to the server when it is back; a form changed meanwhile is never overwritten YouEDC Capture
Data entry deadline after a visit: the portal finds the visits not entered within N working days, shows them to the data manager by site and to the site on its patient list, and sends each site one letter with all its late visits (daily or weekly, patient codes only, without the forms hidden by blinding, all in the audit trail) YouEDC Capture
Queries without noise: a confirmed value does not get the same automatic query again on a new save, an import or ePRO; the study's library of standard query texts with the field, value, visit and form filled in; closing many queries at once with one reason and an audit record for each YouEDC Capture
Study status report on a schedule: recruitment by site against target, visits, missing pages, queries by age, SDV, coding, lock readiness and ePRO, weekly or monthly in Excel and PDF; team members get a letter with numbers and a link only, each sees their own sites and nothing that reveals the arms; every report is kept with its SHA-256, all in the audit trail YouEDC Capture
Scheduled data delivery and delta export: a delivery plan to the statistician, the DSMB or the medical monitor (de-identified or as it is; the whole study or only the changes since the previous delivery — the rows added or changed, a sheet of changes with the old and new value and the reason from the audit trail, the rows removed) in Excel, CSV, SPSS, Stata, SAS XPT or R; daily, weekly or monthly; on the portal with a letter to the recipients or by SFTP with a pinned host key and a .sha256 file; each run freezes a data cut, the file is kept with its SHA-256, all in the audit trail YouEDC Capture
Audit trail review (ICH E6(R3)): the study's audit trail turned into signals worth a look, critical data first — changes after SDV, signature, approval or unlock, late entry, many changes of one value, night and weekend entries, bursts of forms, changes by another person or an unusual role; each with its evidence (who, when, old → new, reason), marked reviewed with a comment or turned into a query, opened again by new changes, with progress, filters and Excel; the lock readiness item follows the review by itself YouEDC Capture
Medical review (ICH E6(R3)): the medical monitor role; listings of adverse events, lab results outside the normal range (L/H) and therapy of every patient on live data; lines marked reviewed one by one or many at once, a line changed by the site after the review comes back; a medical query to the site on the term, the medicine or the value; progress, filters, Excel, all in the audit trail YouEDC Capture
Outcome adjudication: the endpoint committee classifies the study's events blinded to the treatment — two members review each event independently without seeing each other's review, a third decides with a required reason when they differ; an event changed by the site is read again; the event forms and the charter's categories are the study's; Excel, all in the audit trail YouEDC Capture
Biosample tracking: the site registers each tube by its barcode (scanned or typed) with the patient, the visit, the sample type and the time of collection; a barcode is unique in the study; a shipment to the central laboratory with the storage temperature, the courier and the tracking number, a manifest to print and in Excel; the laboratory's receipt with the condition of each tube (haemolysed, thawed, leaked, too little, did not arrive); reconciliation with the laboratory's file — unknown barcodes, another patient, shipped but not received, no result; tubes kept at the site for over a week; all in the audit trail YouEDC Capture
Assistants IA locaux, sans sortie de données du serveur YouEDC Capture
Double data entry from paper CRFs: the forms the study types twice; a second operator types the paper form blind, without seeing the first entry; the data manager settles each difference against the paper, the first or the second value with a comment, the second corrects the form with a reason; a value changed after the decision is compared again; all in the audit trail YouEDC Capture
Casebook du patient en PDF/A : copie certifiée avec les queries et la piste d’audit, une archive par centre YouEDC Capture
Visit document for the medical record: an examination note as PDF from the filled visit, signed by the doctor by hand; the study chooses the forms and titles, the full name and date of birth are written by hand, the treatment arm is never printed YouEDC Capture
Risque des centres (RBM, ICH E6(R3)) : visites en retard, pages inachevées, queries et délai de réponse, retard de SDV, sorties d’étude, taux d’EI comparé à l’étude, problèmes de randomisation ; seuils de l’étude, niveau de risque, registre des revues dans la piste d’audit, rapport Excel, widget sur le bureau YouEDC Capture
Registres, études non interventionnelles et RWE : visites répétées, événements hors calendrier, calendrier du patient, consentements éclairés, issues YouEDC Capture
Remote electronic consent (eConsent): the patient reads the consent form at home by a personal link, answers questions on understanding, can ask to talk to the doctor, and signs with a code from the site; the site plans the talk (a video call on its own video service, a phone call or a meeting at the site), the patient sees it in their own time zone and adds it to the calendar, and the investigator records who explained, when and with what outcome; a study setting opens the signature only after the talk; the investigator countersigns with their e-signature; the text of the version is fixed by its hash, every step is in the audit trail, the patient keeps a PDF copy (21 CFR Part 11, ICH E6(R3) 2.8) YouEDC Capture
Recruitment page and pre-screening: a public page of the study with the text the ethics committee approved (no drug promotion), the sites and a short questionnaire; the consent to the processing of health data before sending, the answer only “may fit” or “does not fit”; leads for the team of the chosen site with statuses, a patient from a lead, deletion on request and after the retention period, a funnel without personal data; switched on in a study only after the approval is recorded YouEDC Capture
Site risk, stage 2: central statistical monitoring — a site's values against the other sites (robust z), data too smooth (small spread, one value in many patients), digit preference (chi-square), trends by the time of enrolment, rates of adverse events, withdrawals, queries and missing values; a threshold corrected for the number of tests, “not enough data” instead of a verdict, a review mark or an action in the site review YouEDC Capture
Site risk, stage 3: protocol deviations as a source, the history of a site's indicators over time, SDV by the site's risk level YouEDC Capture
Versions de l’eCRF : test, publication avec signature électronique, brouillon de la version suivante, comparaison, désactivation au lieu de suppression YouEDC Capture
Clôture de l’étude par étapes : inclusions closes, gel partiel, gel de la base ; chaque passage avec un motif et une signature, le travail ouvert affiché avant un gel, retour en arrière YouEDC Capture
Revue des données : SDV des seuls champs critiques ou du formulaire entier, validation par le data manager après la SDV, une liste des formulaires selon ce qu’ils attendent YouEDC Capture
Codage médical à l’enregistrement du formulaire : événements indésirables, antécédents et traitements codés aussitôt, le reste attend le codeur ; le dictionnaire sous la licence de son titulaire, les centres ne voient pas les codes ; le code de l’EI va dans YouEDC Safety et le SDTM YouEDC Capture
Answer lists of a study: one list for many fields, ready-made lists, dependent lists (district → region), a “From a dictionary” field with the Ministry of Health ICD-10 (МКБ-10) YouEDC Capture
Data cuts: a frozen copy of all the data for an analysis with its SHA-256 fingerprint, a de-identified download (pseudonyms, shifted dates, age, no free text) and a Statistician role YouEDC Capture
A form library: 68 YouEDC standard forms with CDASH codes and lists matched to CDISC CT in Russian and English, search, preview, one field into your own form; a copy of a form or of a whole eCRF of another study, eCRF from Excel and back YouEDC Capture
A form's link with the library: the version it came from, what the team changed, a field-by-field comparison and a missing field of the library with one button YouEDC Capture
The organisation's form library: a study's form is proposed to the library, a steward approves the version with an electronic signature, approved forms stay linked to the organisation's studies, another organisation never sees them YouEDC Capture
Form packs by disease: type 2 diabetes, hypertension, heart failure and CKD, the forms of the disease with visits for a year, as a template in the wizard or with a button in the form library YouEDC Capture
Repeating groups of fields: a block of fields per record, long text and conditions inside the block, a ready-made group “Previous lines of therapy” YouEDC Capture
The form library, next: packs for oncology and vaccines, table shells from a form YouEDC Capture
AND / OR conditions on fields of other forms and the patient's card: showing a field, checks “only when” and across forms, expected visits YouEDC Capture
Files and images at visits: DICOM, photos and PDF from the browser, tags cleaned by PS3.15, a check for personal data in the picture, an image viewer YouEDC Capture
Patient files in one section: widgets (how many are uploaded, which required ones are still expected, on check for personal data), a register in Excel and a ZIP with the audit trail; central reading of images by one or two independent readers with an adjudicator YouEDC Capture
Lab results from the laboratory's PDF: the results go to the form's rows under the lab's names and units, checked against the sheet's range and flag, the investigator checks each value, the site's lab profile YouEDC Capture
Lab results from a photo of the sheet: taken with the phone, cropped at the table's corners, read on the server (Tesseract 5, no AI service), doubtful numbers marked, the investigator checks each value against its piece of the photo YouEDC Capture
Data from any medical document by photo or PDF: a discharge summary, a report, a conclusion; rules and a local language model on the installation's own server, personal data hidden before the reading, the model's value only with a quote from the document, the investigator checks each, the audit trail says the machine proposed it YouEDC Capture
Data from a health record in HL7 FHIR R4: the hospital system's export on the patient's card or through the write API; labs and vital signs by LOINC with units converted, conditions and medications as records of the logs with codes as given; a preview with every value's source, the site's confirmation, the FHIR source in the audit trail; of the Patient only the sex and the year of birth YouEDC Capture
Imaging, next: a viewer with measurements and every codec, series QC and an expert reader, cleaning in the browser before sending, finding personal data in the pixels, RECIST 1.1, reading by scales and with measurements YouEDC Capture
A data quality report: completeness of each variable by site, outliers, entry delay, loss to follow-up YouEDC Capture
YouEDC Biostat: the study's descriptive statistics by themselves: enrolment, taking part, age and sex, the key variables over the visits and their change, adverse events, by arm, a PDF report YouEDC Biostat
A cost estimate by the ОМС tariffs: the healthcare resource use (CDASH HO) priced by the region's tariff table, per patient and per patient-year by arm, with Excel YouEDC Biostat
An analysis plan with the estimands of ICH E9(R1) and a target trial: population, treatment and comparator, variable, intercurrent events with a strategy, time zero, confounders; a design check against the eCRF and versions with SHA-256 that are never changed YouEDC Biostat
Forms and questionnaires in several languages: one form and one set of codes, the texts in the study's languages, Hebrew and Arabic right to left; the patient chooses a language in ePRO, a translation is released with the eCRF version, a licensed scale takes only its official translation YouEDC Capture
A scan of the drug pack and the device: the DataMatrix (Russian labelling, FMD) or the UDI from a photo, a 2D scanner or typed fills the product, INN, batch and expiry date from the study's list by GTIN; the serial number and the crypto elements are not kept YouEDC Capture
The QA environment of a study: the eCRF draft is published as a candidate, tried on test patients who stay from version to version, and released as the same snapshot YouEDC Capture
An eCRF amendment and the data collected: the draft run over the working data before the release (new errors, fields to add, new automatic queries by site) and the list “To add after an amendment” after it YouEDC Capture
A study from its protocol: upload the protocol, and the visits, forms, profile, QA environment and the protocol in the TMF are set up by themselves, with a log quoting the protocol and its pages on what to check; contradictions between sections are shown and the eCRF release waits for the decisions. No AI YouEDC Capture
A protocol amendment in a running study: the amended protocol is compared with the previous one, each change (a visit, a window, a form in a visit, a new form, the planned numbers) is a row with the protocol's old and new words and pages; the accepted rows go into the eCRF draft only, nothing is deleted, and the release takes its reason from the amendment YouEDC Capture
A study from its protocol, next: eligibility criteria into the form one by one, randomisation, the YouEDC Safety deadlines, laboratory tables and the ePRO schedule from the protocol; the draft run of an amendment over the working data in a study with a QA environment YouEDC Capture
UAT of an eCRF amendment in the QA environment: the scripts are made from the candidate's design (the changes and the critical fields), a robot runs the edit checks, the executor signs, another person approves, and only then is the version released without a mark YouEDC Capture
The validation kit of every eCRF version as one ZIP (the specification, the DVP, the UAT scripts and results with their signatures, the traceability, the release record, the SHA-256 of every file) and the UAT scripts as a blank sheet in PDF and Excel YouEDC Capture
The validation package of the platform and of every study by GAMP 5: 25 documents from the plan and the URS to IQ/OQ, the traceability matrix and the certificate, made from the portal's data, a checklist by stage, versions, the supplier's and the client's signatures kept apart, one ZIP and the study's package sent to the eTMF YouEDC Capture
The study archive in ZIP volumes read without YouEDC: the eCRF versions, the data in ODM, Excel and CSV, the casebooks by site, the audit trail with its chain check, signatures, the team, the validation kits; built in the background, all in the audit trail YouEDC Capture
The study archive, next: ODM with the history of changes, the YouEDC Safety cases, the DM and TMF documents, the YouEDC Biostat reports; deleting a real study only after its archive is downloaded YouEDC Capture
YouEDC Biostat, next: a dietary supplement study template, an analysis plan locked before the data, CONSORT and STROBE tables YouEDC Biostat
An export builder: the forms and variables you need, a row per visit or per patient, SPSS, Stata, SAS, R, Excel and CSV with labels YouEDC Capture
A write API for hospital and laboratory systems: a key per system, patients and visit forms through the same checks, consent gate and audit trail; whole patients from one Excel workbook YouEDC Capture
Possible duplicate patients by sex, date of birth and initials: only a fingerprint is kept, the data manager decides each pair YouEDC Capture
Codage, étape 2 : relecture de second niveau, queries au centre sur les termes flous, décisions de l’organisation, passage à une nouvelle version de MedDRA avec analyse d’impact, WHODrug, indicateurs YouEDC Capture
Codage, étape 3 : dictionnaire de formulations cliniques, suggestions sur les fautes avec seuils, grade CTCAE à partir des analyses YouEDC Capture
Plan de gestion des données (DMP) à partir des données du portail YouEDC Capture
API en lecture seule YouEDC Capture
Une étude YouEDC Capture directement depuis l’analyse du protocole YouEDC Capture
Transfert des études et des données de YouEDC 0.2 (les comptes sont déjà là) Portail

Terminé

YouEDC Studio : les outils du data manager

Pour les données de tout EDC : MainEDC™ d’abord, puis Rave, InForm, Veeva, REDCap et Excel.

22 sur 22 faits

Projets DM : échéances, liste de tâches partagée, check-lists de démarrage et de gel, archive YouEDC Studio
Carte des données du projet : l’export est chargé une fois, les outils Studio que ses données permettent s’allument, les autres restent gris YouEDC Studio
Project data: the export is kept as a delivery with its history, the tools take it with no second upload; rights and audit on every file YouEDC Studio
YouEDC Studio inside Capture studies: the tools on the study's live data and its snapshots, with no export YouEDC Studio
Study metrics, the first section of YouEDC Studio: enrolment, data entry lag, cleaning and SDV, queries, changes and AEs by site and by week, the patients and records behind every number; all studies on one screen YouEDC Studio
Un export MainEDC™ tel quel : formulaires, patients, visites, un classeur Excel pour tous les outils YouEDC Studio
Profileur de fichiers pour les exports de tout EDC YouEDC Studio
Du protocole à l’étude : visites, formulaires et champs depuis le calendrier, comparaison des versions, spécification eCRF YouEDC Studio
Contrôle des spécifications eCRF d’autres EDC (Rave ALS, REDCap, Excel) YouEDC Studio
Normes de laboratoire par centre avec versions, valeurs hors normes YouEDC Studio
« Ce qui a changé » : comparaison de deux exports, rapport Excel YouEDC Studio
Rapport des queries : ancienneté, centres, champs sensibles, une feuille par centre YouEDC Studio
Revue des données avec des marques « revu » reportées sur l’export suivant YouEDC Studio
Contrôles inter-formulaires : EI sans traitement et inversement, dates avant consentement et après fin d’étude, fenêtres de visite, doublons YouEDC Studio
Visites en retard et pages manquantes selon le calendrier, par centre et ancienneté YouEDC Studio
Efficacité des contrôles : quels edit checks génèrent des queries inutiles, et quels champs demandent un nouveau contrôle YouEDC Studio
Réconciliation des EIG : pharmacovigilance contre EDC, commentaires reportés YouEDC Studio
Réconciliation fournisseurs : laboratoire central, ECG, PK contre l’EDC YouEDC Studio
Codage médical : CIM-10-CM, CTCAE 5.0, UCUM et démo ATC intégrés ; MedDRA, CIM-10, ГРЛС chargés depuis les fichiers du titulaire de licence YouEDC Studio
Préparation au gel de la base : blocages, compteurs par centre, rapport YouEDC Studio
Conversion d’un export de tout EDC en CDISC ODM 1.3.2 YouEDC Studio
Pipeline CDISC : SDTM, ADaM (XPT, Dataset-JSON, Excel) et Define-XML 2.1 avec rapport de contrôle YouEDC Studio

En cours

YouEDC Safety : pharmacovigilance

Les cas d’événements indésirables graves des études, leur jour 0 et leurs délais.

23 sur 24 faits

File des cas et réception : les quatre critères minimaux, une décision pour chaque notification YouEDC Safety
Notifications depuis YouEDC Capture, depuis les listes d’EIG d’autres EDC (MainEDC™ d’abord) et à la main YouEDC Safety
Jour 0, règles SUSAR, délais de 7 et 15 jours, versions de suivi, rappels YouEDC Safety
Narratif, discussion et signature électronique du cas YouEDC Safety
Formulaire CIOMS I et export ICH E2B(R3) YouEDC Safety
Un bouton « Nouveau cas » bien en vue ; l’origine de chaque cas : YouEDC Capture, à la main, externe YouEDC Safety
Complétude du cas selon ICH E2D, contrôle des doublons, demandes de suivi au centre YouEDC Safety
Indicateurs : délais de 7/15 jours, délais médians, sources et événements fréquents YouEDC Safety
Literature screening: saved searches in PubMed, Europe PMC and Crossref on a schedule, the run log, screening of articles, a case from a case report YouEDC Safety
Coding helper: the MedDRA term and the seriousness criteria from the dictionary and the case text, without AI; a person makes each decision and it goes to the audit trail YouEDC Safety
Medical assessment: RSI in versions with the expectedness it proposes, WHO-UMC and Naranjo worksheets, special situations and pregnancy, the case timeline YouEDC Safety
SUSARs to the investigators with confirmation of receipt, signals in the study, E2B(R3) from partners with the ACK YouEDC Safety
DSUR builder by ICH E2F: listings and tabulations on the data lock point, exposure, RSI, a draft of every section, the text corrected by people, signatures, PDF, Word and Excel YouEDC Safety
What a follow-up changed, the SUSAR submission plan by country with the package of letters and forms, reasons for late reports and CAPA, the product safety profile across studies YouEDC Safety
Taking back a reported case: nullification and amended report (E2B C.1.11) with a signature and the list of recipients; the E2B check before sending by the ICH rules and the official schemas; the authority's ACK closes the reports, a refusal shows its errors YouEDC Safety
The signal log after GVP IX: validation with the evidence, assessment, conclusion and actions (RSI, protocol, consent, DMC, authorities) signed and with deadlines; the DSUR counts the log YouEDC Safety
The Safety worklist: a P1-P4 priority on every case and internal step targets (data entry, medical review, QC) from the 7/15-day clock or the SOP; a late step raises the priority and is escalated to the physicians by e-mail YouEDC Safety
“What next” on a case: what the step still needs, the next step in one press, “Take it myself”, search and a filter by kind in the queue YouEDC Safety
Questions from authorities and ethics committees on a case with the answer date: P1 in the queue, escalation when late, audit YouEDC Safety
Liver alerts from the Capture lab results in Safety intake, with the eDISH plot YouEDC Safety
The DMC safety package: tables by arm, forest plot, Kaplan–Meier, PDF YouEDC Safety
The inspection room: the inspector's access until a day, readiness, what they opened YouEDC Safety
The safety deadline calendar of all projects YouEDC Safety
Soumission électronique aux autorités (manuelle pour l’instant) YouEDC Safety

En cours

YouEDC Sites : le master file

Le master file de l’étude et des centres : ce qui est classé, ce qui manque, ce qui a été demandé au médecin.

5 sur 6 faits

Trial Master File (eTMF, prototype) : zones du TMF Reference Model, versions, contrôle qualité, pages des centres et demandes de documents, rappels d’échéance, mise en production et gel consignés, données YouEDC Capture dans les copies des centres YouEDC Sites
Site file: the delegation log signed by the principal investigator, its cross-check with the work in the EDC and the staff's CV and GCP, reading of new protocol and brochure versions, the site file in one download and inspection readiness YouEDC Sites
The organisation's site directory: a hospital entered once for every study, a duplicate check by tax number and name, loading from Excel, merging duplicates; a Sites page in each study YouEDC Sites
Site performance from real work in the organisation's studies: enrolment and entry speed, queries and answers, retention, SDV findings, deviations; the sites side by side and a file for a sponsor only with the site's consent YouEDC Sites
Dossiers des investigateurs : CV, BPC, licences et échéances, un seul pour toutes les études YouEDC Sites
Profil du centre : équipements, laboratoires, normes, historique des études YouEDC Sites

En cours

YouEDC Trials: running the study

A simple CTMS for monitors and the project manager: sites, enrolment, monitoring visits, action items and deviations.

8 sur 11 faits

The monitor's desk across all studies, site statuses and activation steps, the enrolment plan and fact with a chart (the fact comes from YouEDC Capture by itself) YouEDC Trials
Monitoring visits: preparation, the site's numbers in the report, the author's signature and approval by another person, Word and the TMF inbox; the letter to the site with a read confirmation YouEDC Trials
Action items with dates and reminders, the protocol deviations log with classification and possible deviations found in the data YouEDC Trials
The visit report draft is kept in the browser: without a connection nothing is lost, it is saved when the connection is back YouEDC Trials
Monitoring plan: visit frequency by the site's risk level, late sites on the monitor's desk YouEDC Trials
Statistics by site: the map of sites against the study's median, every number opens the patients behind it, down to the patient's card YouEDC Trials
Statistics across studies: the projects table, sites that need attention, 12-week trends and the enrolment finish forecast YouEDC Trials
Site payments by visits: a fee schedule in versions by protocol version, procedures and site overrides, accruals for visits that are complete, SDV-verified or approved, a statement the sponsor approves and the site confirms, the holdback, VAT and advance recoupment, the budget against actuals, Excel and a PDF act for accounting YouEDC Trials
Patient payments: a stipend per visit and travel reimbursement by the study schedule, a claim with a receipt, approval by the site, no extra personal data at the sponsor YouEDC Trials
Study budget control: the plan by line and site, the actuals from site accruals and patient payments, a forecast to the end of enrolment and overspend signals YouEDC Trials
Protocol deviations as an indicator of site risk YouEDC Trials

En cours

YouEDC Supply: the drug supply

The study drug from the depot to the patient: batches, shipments, site stock and dispensing by visit, without unblinding the arm.

3 sur 5 faits

Depot and sites: kit types by arm, batches released by a second person, the kit list, shipments with a waybill, receipt kit by kit, temperature in transit and quarantine, a movement journal that can't be changed YouEDC Supply
A button to dispense a kit in the visit form: the number is chosen by the arm, the expiry and the site's stock; replacing a damaged kit, returns and counting the drug left; the doctor sees the site's stock YouEDC Supply
Site resupply by a trigger level and the visit forecast, a nightly expiry check, a movement screen with a stock chart for every site YouEDC Supply
Returns to the depot and destruction, batch recall, dosing by weight, transfers between sites, a barcode scanner, Excel export YouEDC Supply
Supply simulation before the start, several depots, temperature logger files, Annex 13 labels, Russian drug track-and-trace (MDLP) YouEDC Supply

Plus tard

Ensuite

Ce que nous construisons ensuite, et ce qu’il faut avant de travailler avec de vrais patients.

Encryption of personal data in the database per study: a key for each project, a recovery key with its owner; switched on for the production installation Portail
Travail avec de vrais patients : responsable du traitement, notification au régulateur, installation validée Portail
Installations pour Israël, les États-Unis et l’Allemagne Portail

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