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ADVERSE EVENT REPORTING Natasha Tomilin, RN BSN DAIT Project Manager.

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Presentation on theme: "ADVERSE EVENT REPORTING Natasha Tomilin, RN BSN DAIT Project Manager."— Presentation transcript:

1 ADVERSE EVENT REPORTING Natasha Tomilin, RN BSN DAIT Project Manager

2 Objectives  Define and identify an adverse event (AE)  Define and identify a serious adverse event (SAE)  Outline the correct documentation of both an AE and SAE  Review proper reporting procedures

3 What is an Adverse Event?  Any occurrence or worsening of an undesirable or unintended sign, symptom (including an abnormal laboratory finding), or disease temporally associated with the use of a medicinal product/procedure, whether or not related to the medicinal product/procedure.

4 Defining an Adverse Event  Adverse Events include, but are not limited to the following: Worsening of conditions present at the onset of the study Concurrent Illnesses Drug reactions or interactions between antiretroviral agents, immunosuppressant medications, or other concomitant medications used on the study

5 Defining an Adverse Event  Abnormal lab values  Clinically significant abnormalities found upon exam or through tests and procedures  Surgical complications of transplant  Subjective reports by the participant that meet AE criteria Example: Participant 001 reports having a severe headache that resolved with OTC medication

6 Defining an Adverse Event  If a condition is present at baseline, is clearly documented, and does not change in severity, it is not reported as an AE  For this trial, all Grade 2 or higher events are reported as adverse events  If the condition resolves or begins to resolve, then worsens again (to a grade 2 or higher), this is considered an AE

7 Documenting Adverse Events  Record the following information in the source documentation: Event Onset date Expected or anticipated Relation to therapy Effect on therapy Outcome/Resolution

8 Reporting Adverse Events  The following tables will be used to grade adverse and serious adverse events: The Division of AIDS Table for Grading Adult Adverse Experiences The Division of AIDS Table for Grading Pediatric Adverse Experiences

9 Grading Adverse Events  For abnormalities not found in the Toxicity Tables, the following scale will be used to estimate grade: Grade 1, Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Grade 2, Moderate: Mild to moderate limitation in activity –some assistance may be needed; no or minimal medical intervention/therapy required

10 Grading Adverse Events Grade 3, Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required and hospitalization possible Grade 4, Life-Threatening: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required; hospitalization or hospice care probable  Any event deemed by the clinician to be serious or life threatening should be considered a Grade 4

11 Reporting Guidelines  Once an AE is recognized, an electronic form should be completed in the IDES  All information contained in the form should be supported by source documentation  Follow-up information should be submitted once available

12 What is a Serious Adverse Event?  A serious adverse event or reaction is defined as any adverse event that suggests a significant contraindication to ongoing therapy

13 Serious Adverse Event  Serious adverse events typically meet the following criteria : Death Life-threatening Inpatient hospitalization or prolongation of an existing hospitalization Persistent or significant disability/incapacity Congenital anomaly/birth defect An event that requires intervention to prevent permanent impairment or damage

14 Serious Adverse Event Reporting  Within 24 hours of the event, complete a serious adverse event form in the IDES  Fax supporting documentation to EMMES: Narrative summary Discharge summary (if applicable) Laboratory tests, consultation and biopsy reports, and/or any other reports Any additional information related to the event All information contained in the form should be supported by source documentation

15 Serious Adverse Event Reporting  Enter follow-up information in the IDES as well as fax follow-up source documentation to EMMES once available  Source documents faxed to EMMES should be identified by participant ID number  Follow-up information should be provided until the event has resolved  EMMES Fax Number: 301-251-1355

16 Serious Adverse Event Review  Both the protocol co-chairs and NIAID co-medical monitors will receive notification of an SAE within 24 hours to determine if any immediate actions must be taken  The Operations Committee will review data listings of the adverse and serious adverse events on a monthly basis  The Data Safety and Monitoring board will routinely review safety data

17 Summary  Please remember to report adverse and serious adverse events within the appropriate timelines  Adverse and serious adverse events should be reported to each individual IRB according to institutional guidelines  Subjects should be informed of new findings throughout the trial

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