Did you know that not all studies require IRB review?
 

Before getting started, please CLICK HERE to review the criteria for IRB review.

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Is your study ready for IRB review?

Principal IRB requests the following information and documents be submitted through our digital platform   LAUNCh .

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For study review with Principal IRB, you must submit the information below.
 

The documents to be submitted include:

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• The Protocol/Study Plan

• PI and Sub-Investigator curriculum vitaes (CV), must be signed and updated within the previous 2 years

• PI's current medical license

• Informed Consent documents

• Drug or Device information (Investigator's Brochure, IND, IDE Instructions for Use, NSR information etc. as applicable)

• Recruitment or advertisement materials

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Prompt review of your study will be dependent on accurate completion of all required documents.

 

Investigators/ Sub-Investigators/ Research Coordinators

Prior to submission, please check with the study Sponsor/CRO for any specific guidelines on how they may want their study handled. If you have any questions, please do not hesitate to CONTACT US at Principal IRB or call us at 919-910-7743.

 

Ready to Submit Your Study?

 

To submit your study application, please login to our state of the art, digital platform,   LAUNCH.  

Once you have accessed our  LAUNCH landing page, new users may request secure access or exisiting clients may login. Registration gives you secure access to e-forms and all of your study documents, 24/7, from any location at any time. Our digital platform is 21 CFR, Part 11 compliant.

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