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WELCOME

Welcome and Thank You for choosing Bluebonnet Ethical Review as your home for subject safety and quality clinical research.

Introduction:

Let us start with an introduction. This way we can meet and understand your exact needs and expectations. A brief call between our teams to discuss what is necessary to meet everyone's goals. 

IRB Notifications:


It's our goal to communicate with you throughout the IRB process.  You can expect to receive confirmation emails of receipt, board assignment, as well as distribution of IRB documents.  Our staff will also reach out to you to help resolve any issues or clarifications required by the Board or Expedited Reviewer.

Customer Service:

We take pride in the ability to connect with each user and company for the overall success of the project. We are available to assist you on your journey. No task is too small. You can reach out to our general email at support@bbirb.com, contacting us by phone or reaching out directly to your IRB Specialist. 

Quality:

To ensure we provide a quality service that exceeds quality requirements and standards we have incorporated quality checks throughout our processes. A Quality Assurance is performed upon each submission into IRBManager to ensure submission completeness prior to review and a Quality Control is performed after each review to ensure IRB determinations have been documented appropriately and communicated to our clients.

Trial Master File Documents:

We all know how important being able to collect files for the TMF are. Your documents are securely stored online and available to you at any time. Simply login into IRBManager to download at your convenience or reach out to our team for assistance.

Distribution of IRB Documents:

Documents will be distributed via IRBManager, you can expect to receive the following:

  • IRB Notice indicating the Board actions.

  • Tracked version of the Informed Consent documenting the Board revisions.

  • Finalized version of the IRB approved Informed Consent.

  • Revisions made to any submitted materials (i.e. Recruitment) along with the finalized version.

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