Safety for the DMC and inspections, fast metrics and a wide patients grid

YouEDC Safety

• “What next” on the case summary: what the current step still needs. In data entry these are the ICH E2D minimum, the MedDRA code, the onset, the outcome and the narrative. In the medical review they are the sponsor's causality, the expectedness and the signature. In QC they are the QC signature, the approval and the reports due. At any step the list also shows late follow-up requests, questions from authorities and a refused ACK. Each line opens its tab, and a button moves the case to the next step. “Take it myself” assigns the case to you. The queue has a search by number, subject, site and term and a filter by kind YouEDC Safety
• Questions about a case from an authority, an ethics committee or a partner, with the date of the answer. While a question is open the case is P1 in the queue, and the project page and the case header remind of it. When the answer date passes, the assignee and the physicians get one e-mail. The question, the answer and the delay go to the audit trail. The demo has an authority's question answered on time and an ethics committee's open one YouEDC Safety
• Liver alerts from the lab results. When a site saves results in YouEDC Capture and the patient reaches a potential Hy's law (ALT at least 3 x ULN and bilirubin at least 2 x ULN within 30 days) or ALT above 20 x ULN (CTCAE grade 4), Safety intake shows the report at once with the peaks, the dates and the study's eDISH plot with this patient in red. A case takes one press, as an important medical event; the ULN comes from the study's ranges and the arm is never shown. A daily reading picks up results saved earlier YouEDC Safety
• The DMC safety package in one press: patients with SAEs by arm, by MedDRA body system and term, the rate per 100 patient-years, a forest plot of the risk difference against placebo with its 95% interval and the Kaplan–Meier curve of the first SAE. By arm only for unblinded members (the closed session); everyone else sees one pooled column. A PDF for the meeting, every download in the audit trail YouEDC Safety
• The inspection room: an inspection with its days and the period under review, the inspector's read-only access until a set day (then the daily job switches it off), the list of what the inspector opened, and nine readiness points: reports on time, late reports without a reason and CAPA, overdue reports, late steps, late questions and signals, closed cases without the approval, the RSI and the DSURs. The demo has a Roszdravnadzor inspection running YouEDC Safety
• The deadline calendar of all your projects: 7/15-day reports, step targets, answers to authorities, follow-up requests, signals, DSURs and inspections. A month on a wide screen and the next 30 days as a list, late ones on top, the list only on the phone YouEDC Safety