Reportable Events

Sterling IRB requires Principal Investigators (PI) to promptly report all events that may constitute unanticipated problems involving risk to subjects or others and new or updated safety information relating to the study or study product.

Unanticipated Problems Involving Risk to Subjects or Others are considered, in general, to include any incident, experience, or outcome that meets the following criteria:

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New Program: Random Site Audits

See Chapter 4-D of the Investigator Handbook for details of Sterling IRB’s new program to audit investigative sites meeting select risk and/or enrollment criteria at random.

Updated Policies: Cognitively Impaired Subjects

Please make note of changes in Sterling IRB’s policy pertaining to the review of studies that may involve cognitively impaired persons:

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WHY CHOOSE STERLING?

Innovation. Passion. Commitment. We believe these are the essential components of strong teamwork.

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REVIEW BOARD

A diverse group of scientific and non-scientific members with nearly a century of collective IRB experience.

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RESEARCH IN CANADA

Sterling IRB has formed a strategic partnership with Veritas IRB.

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