Temple University utilizes an electronic web-based Serious Adverse Event Reporting system. The system was developed to assist investigators with the development, updating and managing adverse and serious adverse event reports to the Temple University IRB. The system is utilized for developing both Internal SAE's and External SAE's) for the TU IRB Clinical Trials at Temple University. All final submissions of Serious Adverse Event Reports must be in paper format with the Principal Investigator's Signature.
PI Authorization Form This form is required to be completed by the Principal Investigator for study team members to access the Investigator Protocol to assist with the development of Adverse Event Reports.
AccessNET ID Information -To access the Temple SAE reporting system an AccessNet ID and password is required. An AccessNet account allows you to use Temple University's web and computing resources including the SAE reporting system and provides a secure login to the application.
At the start of each trial the Investigator must complete the PI Authorization Form to allow their research staff access to the SAE reporting system for the Principal Investigators Ongoing Trials. Without this authorization only the Principal Investigator will be able to access and use the system to report AE's and SAE's.
Temple Subject Enrolled into a Clinical Trial
Internal SAE ReportingTimeline: Submit to the IRB within 2 working Days
Required Steps:
1.
Log into the Temple IRB Adverse Event Web-site: You must have been authorized to access specific trials by the Principal Investigator
2.
Complete the Required Information into the Web-site (See Reporting Manual for complete description)
Create a New Adverse Event Record
Find an Adverse Event Record
List All Adverse Events Record
Adverse Event Report in Non-Temple subject
3.
Print the Final Report
Individual SAE Report for Temple Subjects
4.
Principal Investigator Signs and Dates the Report
5.
Provide the Complete Paper Documentation to the IRB Office
Required Documentation (Must provide 1 Original and 11 Copies of these documents)
Individual SAE Report- Signed by the PI
IND Safety Reports or Medwatch Forms Received by the Sponsor
Copy of the Current IRB approved Informed Consent
Additional Information if required
Additional Information regarding the subjects event at the discretion of the Investigator or as requested by the IRB (i.e. Medical History, Concomitant Meds)
Revised Informed Consent if changes are required (Submit 2 Updated Original Consents for Review and 1 that highlights the changes)
Provide Updated Investigator Brochure with the new information
Non Temple Subjects SAE Reports
"External" SAE Reporting Timeline: Report within 10 business days
1.
Log into the Temple IRB Adverse Event Web-site: You must have been authorized to access specific trials by the Principal Investigator
2.
Complete the Required Information into the Web-site (See Reporting Manual for complete description)
Create a New Adverse Event Record
3.
Print the Final Report
Batched Report Format- Multiple IND Safety Reports completed per report
4.
Principal Investigator Signs and Dates the Report
5.
Provide the Complete Paper Documentation to the IRB Office
Required Documentation (Must provide 1 Original and 11 Copies of these documents)
Batched SAE Report - Signed by the PI
IND Safety Reports or Medwatch Forms Received by the Sponsor
Copy of the Current IRB approved Informed Consent
Additional Information if required
Additional Information regarding the subjects event at the discretion of the Investigator or as requested by the IRB (i.e. Medical History, Concomitant Meds)
Revised Informed Consent if changes are required (Submit 2 Updated Original Consents for Review and 1 that highlights the changes)
Provide Updated Investigator Brochure with the new information
Submit Information: Richard Throm, IRB Coordinator Attn: Adverse Events Sub-Committee
3425 Carlisle Street-3rd Floor Hudson Building
Philadelphia, PA 19140
Following submission to the IRB, the IRB Adverse Events Sub-Committee will review the reports and a correspondence will be sent to the Investigator. The IRB Sub-Committee meets once a month.
