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Search Category: Monitoring Plans (Data and Safety)

Clinical Research Safety Monitoring Policy

Type: Example Policy
Author: Portsmouth Hospitals NHS Trust
Keywords: SAEs, AEs, SUSARS, SARS, Adverse Events, Protocol, development, safety, safety monitoring, GCP,
Additional Detail: This policy includes information for safety monitoring in protocol development. Section 7, p12
Link Reference: 935
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Statistical Analysis Plans

Type: Guidance
Author: European Network of Centres for Pharmacoepidemiology & Pharmacovigilence
Keywords: Methodological Standards, Pharmacoepidemiology
Link Reference: 934
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