Adverse event reporting and harms {22}
adverse drug reactions
PREGNANCY COMPLICATIONS, ADVERSE REACTION, ADVERSE DRUG REACTIONS
All AEs must be documented in the subject record, and appropriate medical treatment must be provided. The investigator will assess the causal relationship between the study drug and the AE. The investigator shall notify the sponsor immediately of the occurrence of an SAE.The sponsor must document all AEs reported to him in detail and, upon request, submit these to the member states concerned. The sponsor must inform the member states concerned and the investigators involved in the clinical trial about every suspected unexpected serious adverse reaction that comes to his attention immediately. For the duration of the clinical trial, the sponsor must submit to the member states concerned, once a year or upon request, a list of all suspected cases of serious adverse drug reactions that have occurred during the trial as well as a report on the safety of the subjects (Development Safety Update Report). Any pregnancy that occurs during study participation must be reported to the sponsor immediately. Pregnancy complications and elective terminations for medical reasons must be reported as an AE or SAE. Any SAE occurring in association with a pregnancy brought to the investigator’s attention after the subject has completed the study and considered by the investigator as possibly related to the investigational product must be promptly reported to the sponsor. In addition, the investigator must attempt to collect pregnancy information on any female partners of male study subjects who become pregnant while the subject is enrolled in the study.