Safety Reporting

IRBco requires reporting of all events that are considered unanticipated problems involving risk to study subjects or others. Also, any new or updated safety information relating to the study and products provided as part of the study. Any events or new information must be reported to IRBco within 10 days of the occurrence. Submission of safety reporting and documents should be submitted through AllianceNet. Following is a list of items that qualify as a reportable event:
  • IND Safety Reports
  • Device Reports
  • FDA or sponsor safety alerts
  • Data Safety Monitoring Board Reports
  • Updated Investigator Brochures
  • Updated Package Inserts
  • Updated Device Manuals
  • Other relevant safety information

These items may be submitted by the Sponsor/CRO on behalf of all sites in the study. Changes to previously reviewed documents should be submitted with a summary of changes and the final new version of the document. PI’s must report safety information if the sponsor does not submit on their behalf. Also, the PI is responsible for reporting any events relating to the study or the study product which occur at their specific study site. The PI must report any event that is Serious, Unanticipated and Related to the study product or procedures. If the event meets all three requirements it must be reported through AllianceNet.

IRBco will acknowledge the documents through the AllianceNet system.
 
 

Awards

IRBco is awarded Full Accreditation by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP). Accreditation validates our comprehensive program which integrates ethical reviews, state-of-the-art technology and staff development to create an environment of responsible and ethical human subject protection. We provide our services at levels beyond client expectations and that exceed federal requirements for safeguarding participants. We believe that accreditation leads to an increased level of professional accountability.

 
 
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