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If this condition is not fulfilled, the reaction will be reported to the user as unbalanced.
All SAEs or a suspected unexpected serious adverse reaction will be reported to the trial coordination centre within 24 h and to the relevant authorities in accordance with current regulations.
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The number of participants reporting adverse reactions, and the duration and severity of the adverse reactions will be reported.
All serious adverse reactions will be reported to the Danish Medicines Agency in an annual report together with a report on patient safety.
All other sudden unexpected serious adverse reactions will be reported to the Danish Medicines Agency at the latest 15 days after sponsor/investigator has gained knowledge of these.
All other suspected serious unexpected adverse reactions will be reported to the Data Monitoring Ethics Committee (DMEC), Trial Steering Committee (TSC), trial sponsor and ethics committee within 15 days of first knowledge.
All serious adverse events and serious adverse reactions will be reported to the Sponsor via the Research & Development office and the regulatory authorities as per the North Bristol NHS Trust standard operating procedure as soon as the research team is aware of it (within 24 h) and a written report will follow within 7 days as per ICH GCP guidelines.
Complying with the current legislation, any serious adverse reaction (SAR), or unexpected serious adverse reaction, (USAR) will be reported to the health authorities within 24 hours of being detected.
Any suspected unexpected serious adverse reaction (SUSAR) will be reported to the Spanish Agency (AEMPS).
Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) will be reported to a Data Safety Monitoring Committee (DSMC).
Suspected Unexpected Serious Adverse Reactions (SUSARs) will be reported within the statutory timeframes to the MHRA and REC, as stated below.
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