Process Change Site Information Updates

Effective April 7, 2012, Sterling IRB will require the submission of the Change in Site Information Form for any change in sub-investigator(s) for a previously approved Investigator/Site. In addition, the Change in Site Information Form will replace the Add or Change Site Submission Application.

All requests for IRB review of changes in site information (i.e. change in site name, phone number, site contact

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New SAE Reporting Policy

Consistent with FDA and OHRP guidance on Adverse Event reporting to IRBs, Sterling IRB no longer requires the submission of Adverse Events unless the event is serious, unexpected, and related or possibly related to participation in the research. This change in policy was effective April 13, 2012. The revised Serious Adverse Event Report form is available in the Investigator Forms section of the Sterling IRB website and may be accessed here.

Process Change Electronic-Only Documents

Effective March 26, 2012, Sterling IRB will no longer mail hard copies of Continuing Review Approval Documents. These documents will only be provided on SilverLink or by email.

As previously noted, effective August 1, 2010, Sterling IRB will no longer mail hard copies of Acknowledgments of items such as IND Safety Reports, Form FDA 1572s, CVs, Licenses, Investigator's Brochures, Financial

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Sterling IRB No Longer Requires the Submission of Form FDA 1572s

Effective November 11, 2011, Sterling IRB no longer requires the submission of Form FDA 1572s. A Supplemental Site Form should be submitted with the Submission Application for the Investigator/Site for each location where research will be conducted. For changes in research location, an Add or Change Site Submission Application must be submitted. These forms are available on the Sterling IRB website and may be accessed here.

Sterling IRB Announces New IND Safety Reporting Policy

Consistent with FDA and OHRP guidance on Adverse Event Reporting to IRBs, effective November 11, 2011, Sterling IRB no longer requires the submission of IND safety reports (“External Adverse Events”) unless the event(s) may represent an unanticipated problem involving risks to subjects or others. Please see Chapter 7 – Reportable Events of the Sterling IRB Investigator Handbook for additional information regarding Safety Reporting guidelines.

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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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