Clinical Protocol Deviations FDA / EMA Regulations

We Comply with the Regulations that Apply to Us 
We Make Sure Your Submission Complies with the Ones that Apply to You 

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.

Protocol Deviations Regulations and Guidelines

Here are helpful links to the FDA and EMA guidance documents that address the difficulties raised by protocol deviations in clinical trials.

FDA's Bioresearch Monitoring (BIMO) program

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 (…).


Instructions for FDA inspectors

7348.811 Clinical Investigators and Sponsor-Investigators 

7348.810 Sponsors, Contract Research Organizations, and Monitors 


Human Regulatory – Q&A Good Clinical Practice

(...) 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. (...)


Q&A on Guideline E3

ICH guideline E3 - questions and answers (R1)

Protocol Deviation Software

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Protocol Deviations Glossary Page

The list of Terms and Definitions related to Protocol Violations, Deviations, and Exceptions.

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Protocol Violations Tools, Resources and Templates

We have assembled a useful repository of links to useful resources to you on your Protocol Violations exploration.

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Electronic Protocol Deviation Management Software

The Software Platform for Clinical Professionals Willing to Manage Protocol Deviations in a Fast and GxP Compliant Way

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