Chemokeyp: A Feasibility Study for Realtime Safety Data-Capture for Potential Serious Adverse Drug Events

Chemokeyp is a feasibility study testing a secure ED-Oncology interface for patients receiving chemotherapy who may present to unscheduled care with possible treatment-related complications. Participants are enrolled through Oncology and issued a medical-alert-style wristband with a QR code. If they attend the Emergency Department, staff can scan the QR code, access a generic study landing page, and, after SVUH authentication, complete a short structured checklist about possible serious adverse events such as infection, chest pain, vomiting, syncope, or other red-flag symptoms. The platform is designed as a secure research data-capture portal, not an electronic health record or clinical documentation system. It does not read from or write to the hospital EHR, does not provide clinical decision support, and does not change usual clinical care. Data entered by ED clinicians are limited to predefined structured fields for research and safety-signal feasibility purposes. The study will assess whether ED clinicians can complete the checklist in real time, whether the information can support earlier notification to the research/trial team, and whether this data accurately corresponds with verified serious adverse events. If feasible, Chemokeyp could help improve communication between Oncology, Emergency Medicine, and trial teams, supporting safer care for patients on chemotherapy and informing future development of ED-oncology digital safety tools.

NCT Number	NCT07592234
Lead Sponsor	St Vincent's University Hospital, Ireland
Conditions	Serious Adverse Events, Patient Safety, Pharmacovigilance, Oncology
Enrollment	100 participants
Start Date	2026-02-01
Primary Completion	2026-08-01 (estimated)
Study Completion	2027-01-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-18