Protocol Deviation
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Ethical’s software, systems and services comply with all regulations that apply to clinical protocol deviations: GxP, GAMP 5 Validation, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11, ISO 27001. From the adoption of your protocol deviations definition to your FDA and EMA submissions, we help you cover every step, from the forming and staffing of protocol deviations management to the creating and maintaining of audit trails.
FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits (…) established to assure the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications (…).
7348.811 Clinical Investigators and Sponsor-Investigators
7348.810 Sponsors, Contract Research Organizations, and Monitors
DOWNLOAD(...) EMA has published a notice for clinical trial sponsors to highlight the requirements for the qualification and validation of computerised systems used for managing clinical trial data. (...)
DOWNLOADICH guideline E3 - questions and answers (R1)
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eDeviation
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The list of Terms and Definitions related to Protocol Violations, Deviations, and Exceptions.
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We have assembled a useful repository of links to useful resources to you on your Protocol Violations exploration.
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The Software Platform for Clinical Professionals Willing to Manage Protocol Deviations in a Fast and GxP Compliant Way
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