The Western IRB Utilizes a paper submission process with formatted reporting coversheet for Internal Serious Adverse Events that occur during the trial. The Western IRB also receives External or IND Safety Reports from the Investigator however a formatted coversheet is not required and a cover memo should be developed and provided.
Report must be submitted to WIRB within 10 days of the study team becoming aware of the Serious Adverse Event
Unanticipated Adverse Events - Use the log to report non-serious unanticipated adverse events occurring at your site which are also possibly related to the study design, procedures, or drug/device. Send the log to WIRB on a quarterly basis with the Continuing Review Report Form. Do not use the log to report serious events; use the Ten Day form even if the ten day deadline has passed.
Non-Temple Subjects Enrolled into a Clinical Trial:
The document states, "If the Sponsor, CRO or SMO does not submit IND or other safety reports to WIRB on behalf of your site, you are required to submit them within 10 days of the date you receive them."
A Coversheet should be created in memo format that includes the Clinical Trial Title, the IND Safety Report Number, and a specific request that WIRB provide acknowledgement of receipt of the report for your regulatory file.
Copy of the IND Safety Report should be faxed to WIRB and copy of the report sent to TU IRB for their files.
Report is due within 10 days of the date received from the sponsor
Provide Western IRB with 1 Original and provide Temple IRB with 1 Copy of all Serious Adverse Event Reports. You must request that Western IRB provide documentation that they received the report. The Temple IRB will maintain a copy in the study file, but will not review or provide acknowledgement that the IRB received the report.
Mail Reports to:
Western IRB
3535 Seventh Avenue
Olympia, Washington USA 98502
