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
Aankomende klinische onderzoeken
-
Beijing Tsinghua Chang Gung HospitalPeking Union Medical College Hospital; First People's Hospital of Chenzhou; Tsinghua... en andere medewerkersNog niet aan het werven
-
Beijing Tongren HospitalNog niet aan het wervenBijziendheid | Preventie en controleChina
-
Cancer Institute and Hospital, Chinese Academy...WervingGemetastaseerde colorectale kanker (CRC)China
-
Sümeyye BALNog niet aan het wervenOngerustheid | Zwangerschap met een hoog risico
-
Brandeis UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Detroit Recovery...WervingAlcoholgebruiksstoornis | Digitale gezondheid | HerstelresultatenVerenigde Staten
-
University of ManitobaSeven Oaks Hospital Chronic Disease Innovation Centre; Can-SOLVE CKD NetworkNog niet aan het wervenChronische nierziektenCanada
-
University of MichiganNog niet aan het wervenBoezemfibrilleren | Thrombotic Risk
-
Antag TherapeuticsWervingAdults With Overweight/Obesity and Type 2 DiabetesVerenigde Staten
-
Assiut UniversityNog niet aan het werven
-
Chia Tai Tianqing Pharmaceutical Group Nanjing...Nog niet aan het werven
-
University Hospital, GrenobleNog niet aan het wervenSpontane ademhalingsproef op de intensive care
Clinical Research Jobs
-
China
-
ChinaIndia - Telangana - HyderabadIndia - Karnataka - BengaluruIndia - Maharashtra - Mumbai
-
United States - North Carolina - Durham
-
United Kingdom - Guildford
-
India - Bengaluru
-
United States - North Carolina - Morrisville
-
China
