Expedited Reporting of Serious Adverse Events. Regulations require that VentiRx Pharmaceuticals or its representatives to report any suspected adverse reactions1 that are both serious (§8.1) and unexpected (§8.4). Such events must be reported to the FDA, applicable regulatory authorities, and all participating investigators (i.e., all investigators to whom VentiRx is providing drug under its INDs or under any investigator’s IND) within 15 calendar days after VentiRx or its representative receives the information and determines that it qualifies for reporting. Such notification must occur within 7 calendar days if the SUSAR was fatal or life-threatening.
Expedited Reporting of Serious Adverse Events. RIBOMIC (or designee) will provide the Principal Investigator with a reporting cover letter and an anonymized MedWatch 3500A for expedited reporting of SAEs to the IRB or Independent Ethics Committee (IEC). The Principal Investigator is responsible for receiving and reviewing expedited safety reports, submitting expedited safety reports to the IRB or IEC, and maintaining copies of expedited safety reports in the study records.
Expedited Reporting of Serious Adverse Events. All Serious Adverse Events (Serious Adverse Device Effects both Anticipated or Unanticipated), including any Device Deficiency that could have led to a SADE, must be reported to the Sponsor or designee within 24 hours of knowledge of the event. It is the responsibility of each Investigator to report all Serious Adverse Events and/or Serious Adverse Device Effects and Device Deficiencies that could have led to a Serious Adverse Device Effect to their IRB, according to Institutional Review Board requirements.
