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

One Shot for Osteoarthritis? Scientists Report Joint Repair in Animals Within Weeks
Pfizer to Test New Pneumococcal Vaccine for Children Needing Catch-up Immunization
Tuberculosis Treatment Is a Long Marathon. A New Trial Will Test if It Can Be Shortened to 17 Weeks
After a Type 1 Diabetes Diagnosis, the Race Against Time Begins. A New Trial Aims to Save Natural Insulin Production
How Low Should "Bad" Cholesterol Go? Trial Tests New Target for Highest-Risk Patients
DYNE-251 to Be Assessed in Phase 3 Trial in Patients with Duchenne Muscular Dystrophy
Oral GLP-1 to Be Tested in People with Type 2 Diabetes Fasting During Ramadan

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

3
订阅