Safety Reporting

Current section refers to the item 4.11 Safety Reporting of the INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2). It provides an overview of requirements for reporting of Serious Adverse Events occurring during a clinical trial.

 

4.11.1 All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports.

The immediate and follow-up reports should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification numbers, and/or addresses.

The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC.

4.11.2 Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol.

4.11.3 For reported deaths, the investigator should supply the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports).

Clinical Research News

A Negative Stool Test Isn't the Whole Story: A New Method to Be Tested Before Colonoscopy
A New Way to Prevent Strokes in Arrhythmia: Testing Drugs That Target Just One Protein
Two Viruses, One Shot: GSK to Test a Combined Vaccine Against RSV and hMPV
A Biweekly Injection Instead of Weekly: New GLP-1 to Be Compared Against Semaglutide
GLP-1 is No Longer Just About Weight: A New Oral Drug to Be Tested for Kidney Disease
A Lung Nodule on a CT Scan: Could a Blood Test Help Tell Cancer from a False Alarm?
The 'Hidden' Cholesterol Diet Can't Fix: New Drug to Be Tested on Heart Artery Plaque

即将进行的临床试验

Clinical Research Jobs

More jobs

赞助者和合作者

医疗条件

药物干预

订阅