SilverLink - 21 CFR 11 Compliant

We are pleased to announce that Sterling IRB's web portal, SilverLink, is in compliance with Title 21 Part 11 of the Code of Federal Regulations. SilverLink allows sponsors and investigators to easily submit and access important research documents electronically, streamlining the research process even further.

Sterling IRB Receives Full AAHRPP Accreditation

Sterling Institutional Review Board is pleased to announce that it has received full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Accreditation signals to sponsors and investigators that Sterling IRB provides comprehensive protections for research participants. Sponsors and investigators now have an industry-recognized assurance of Sterling’s commitment to exceed federal regulatory requirements and to continually improve quality and efficiency.

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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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