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

¿Es seguro hacer pruebas de detección del cáncer de ovario con un análisis de sangre en mujeres sin riesgo elevado?
Tras la cirugía no se detecta cáncer de mama invasivo, pero sí ADN tumoral en sangre: ¿debe intensificarse el tratamiento?
¿Deben las personas mayores tomar aspirina de por vida tras un infarto o un stent?
¿Se puede evitar una lumpectomía en algunos tumores pequeños de mama? Un estudio probará una única radioterapia de alta precisión
¿Puede una inyección al mes ayudar a mantener la pérdida de peso después de Wegovy o Zepbound?
No es otro GLP-1: petrelintide entra en fase III con 3.900 participantes
¿Se pueden tratar las varices sin agujas, catéteres ni calor? Un nuevo método se prueba por primera vez en humanos

Próximos ensayos clínicos

Clinical Research Jobs

More jobs

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

Suscribir