FAQs: Adverse Events, Serious Adverse Events, and External Safety Reports

Please also refer to the new Serious Adverse Event (SAE) Reporting resources accessible from: Serious Adverse Events | SWOG. 
  1. Does SWOG have a policy regarding site review of external safety reports?

    SWOG has no policy on review of external safety reports. For trials under a local IRB, we defer to the policies and procedures of the local IRB. For trials under the CIRB, we defer to local institutional SOPs. If your site has a policy regarding this, SWOG recommends you follow that policy. If you do not already have a policy, we recommend that one be implemented.

    Best practice would be to download (no need to print unless it’s your site policy) all external safety reports and file them in the regulatory binder in case they need to be accessed in the future. Best practice would also include periodic review by the PI to fulfill their obligations to protect the rights, safety, and welfare of human subjects.

    Site review of external safety reports by sites can occur in many ways. One common method is to compile a list/spreadsheet of all safety reports that are considered related and unexpected to an IND. The PI can review the list periodically for any concerning events and review those individual reports if necessary. This is just an example; many other processes would be acceptable.

    Please feel free to contact ADR@swog.org with any additional questions.
     
  2. Patient 123456 had an adverse event on the last day of Cycle 1. Do I report the AE with Cycle 1 or Cycle 2?

    The adverse event should be reported within the same cycle it occurred. In this example, since the AE occurred on the last day of Cycle 1, it should be reported on the Cycle 1 Adverse Event Report.
  1. Patient 234567 experienced Grade 1 peripheral neuropathy starting on Day 8 of Cycle 3. Since the neuropathy is only Grade 1, does this need to be reported as an adverse event?

    Yes; unless otherwise specified in the protocol, all grades of adverse events (1-5), including abnormal laboratory findings, must be reported on the study’s Adverse Event Report form regardless of attribution to protocol treatment or clinical significance.

    Questions regarding adverse event reporting may be directed to ADR@swog.org.

    Source: ORP Manual Chapter 15 Adverse Event Assessments (Login with CTEP credentials required to access link).
     
  2. Who do I contact for questions pertaining to SAEs?

    Please refer to the Serious Adverse Events | SWOG webpage. In particular, you may find the SWOG Expedited Reporting Guide to Serious Adverse Event Report Submission to be helpful. For any SAE-related questions that are not addressed on the above webpage, please contact ADR@swog.org or 210-614-8808 (Option 6).