Temple University utilizes 3 independent Institutitonal Review Boards to review and approve a research trial. The Adverse Event and Serious Adverse Event Reporting will be completed by the Principal Investigator according to the IRB's operating procedures that approved the protocol. Temple University IRB should receive a copy of all Serious Adverse Event Reports. It is important to follow the IRB requirements to maintain compliance with Federal and Institutional Policies. The Principal Investigator is responsible for the complete, timely and accurate reports to the Institutional Review Board. Please select the IRB that provided approval for your clinical trial and click on the link below for the reporting requirements.
The Code of Federal Regulations 45CFR Part 46 states that the IRB is charged wtih reviewing adverse events that are unexpected and have a reasonable possiblity of relatedness to the study drug, interventions, and/or procedure(s). The directive mandates procedures for "prompt reporting" of "any unanticipated problems involving risk to subjects and others". The code of federal regulations 21 CFR 312 contains the reporting rules for Investigational Drug Studies and 21 CFR 812 contains the reporting requirements for Device Trails.
Definitions:
Adverse Event - Adverse Event is broadly defined as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of an investigational product, or participation in the study whether or not considered related to participation in the research.
Serious Adverse Drug Experience (SAE): Any adverse drug experience occuring at any dose that results in any of the following OUTCOMES:
Results in Death
A immediate Life Threatening Experience
Inpatient Hospitalization or Prolongation of an existing Hospitalization
A persistent or significant disability/incapacity
Congenital Anomaly/Birth Defect
Important Medical Event that may not result in death, but be life
threatening or hospitalization may be considered a serious adverse
drug experience when based upon appropriate medical judgment.
Adverse Event - Adverse Event is broadly defined as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of an investigational product, or participation in the study whether or not considered related to participation in the research.
SAE's occuring to Temple Subjects - "Internal SAE": Serious adverse event as defined above that occurs to a subject who consented to participate in a clinical trial being conducted at Temple University (Inpatient or Outpatient Clinical Trials). Each Serious Adverse Event must be reported as an individual report. However mulitple internal reports can/should be submitted so complete information is provided to the IRB.
SAE's occuring in non-Temple Subjects - "External SAE"- IND Safety report or Medwatch Report of a SAE that occured during a trial to a subject not enrolled at Temple University. These reports are provided by external sponsors of the clincial trial (Inpatient or Outpatient Clinical Trials).
Individual SAE Report - Used to report "Internal SAE's" occuring to Temple Subjects. The report requires 1 Serious Adverse Event documented per report submitted to the IRB. The report has specific information required and should include all details pertaining to the Report. Select the IRB above to review the specific reporting requirements.
Batched SAE Report - Used to report "External SAE" reports or IND Safety letters that are Serious, Unexpected, and Possibly related to the Investigational Agent being studied.
