Guideline on Strategies to Identify and Mitigate Risks for First-in-Human and Early Clinical Trials with Investigational Medicinal Products¶
European Medicines Agency. (2017). Guideline on Strategies to Identify and Mitigate Risks for First-in-Human and Early Clinical Trials with Investigational Medicinal Products. European Medicines Agency.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Mechanisms¶
- Emergency Unblinding Procedure
- Its strength is squaring an ethical circle: it preserves participant safety without collapsing the entire blind, and it feeds the expedited-safety reporting that regulators require — an unblinding often precedes a SUSAR report.
This sourceClinical-trial protocols should provide rapid emergency unblinding for immediate subject management and processes for expedited SUSAR reporting.
- Its strength is squaring an ethical circle: it preserves participant safety without collapsing the entire blind, and it feeds the expedited-safety reporting that regulators require — an unblinding often precedes a SUSAR report.
Verification¶
Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.
Does it back the claim? Not recorded. The single citation of this work carries no recorded support check.
Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.
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Registry ID ref:7da247ec10f0 · see in the full table