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

Breast Cancer Treatment Is Over, But Sleep Hasn't Returned: Smartphone Apps to Be Tested on 747 Women
Hearing a Gasp Isn't Enough: Why a New Trial Adds Smartphone Video to Emergency Calls
What an Exhale Can Tell: New Test to Be Trialed on 1,000 Patients with Suspected Stomach or Bowel Cancer
Before the First Memory Problems: Roche to Test Drug in People with Alzheimer's Biomarkers
A Diaper Photo Could Help Spot Liver Disease in Babies: UK Tests AI
Tumor Remains After Treatment: New Combination to be Tested in 1,000 Patients with Aggressive Breast Cancer
HIV Treatment Without Daily Pills: Gilead to Test New Long-Acting Regimen in Two Phase 3 Trials

Připravované klinické studie

Clinical Research Jobs

More jobs

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

Předplatit