Forms

Initial Study Submission Guidelines

The staff at Liberty IRB, Inc. is happy to assist you with the application process. To provide you with the shortest document turn around, it is essential that all forms are completed as indicated. All forms may be completed online and printed, or printed and completed manually. Upon receipt of your submitted materials, you will be contacted by a project manager who will keep you informed about the processing of your documents.

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Continuing Review / Study Closure

Sites will be notified one to two months prior to study approval expiration date. You will be requested to complete a continuing review form and submit a copy of your current consent.

Reportable Events

Liberty IRB requires Investigators to report within 5 working days any changes significantly affecting the conduct of the research or that increase the risk to participants, including any of the following using the Reporting Form.

· Internal adverse events which are unexpected and related to the research;

· External adverse events which are unanticipated problems involving risks to participants and others, as determined by the study investigator;

· Changes made to the research without prior IRB approval in order to eliminate apparent immediate harm;

· Other unanticipated information that indicates participants or others might be at increased risk of harm such as a new risk, identified in an interim safety analysis, revised package insert, revised investigator brochure, publication in the literature or a DSMB report.

· Unanticipated problems involving risks to participants or others will be defined as any report of information that is (1) unanticipated and (2) indicates that participants or others are at increased risk of harm;

· Allegation or finding of non-compliance;

· Major protocol deviations or violations that might affect the rights safety and welfare of subjects;

· Termination or suspension of the clinical trial by the study sponsor;

· Unanticipated, serious adverse drug or device effects

Initial notification is requested within 5 business days of discovery. Initial notification should include any details surrounding the event which are available. Follow up completion of the Reporting form is required within 10 days of discovery.

What SAEs are unanticipated problems and need to be reported to the IRB?

Reporting Form

Institution Forms

Send all materials to our new location:

Liberty IRB, Inc.
1450 S. Woodland Blvd.
Suite. 300A
DeLand, FL 32720
Phone: 386-740-9278
Fax: 386-740-9278

Liberty IRB, An Independant Central IRB

Forms

Initial Study Submission Guidelines

Continuing Review / Study Closure

Reportable Events

Institution Forms