Frequently Asked Questions

Who should I contact to submit an IIS?

You should contact your regional Medical Science Liaison by clicking here.

Should I submit a conceptual outline or a full study proposal?

You should submit a concept of the study for CSL Behring’s initial review. If your concept is approved, your Medical Science Liaison will help you with a full submission.

What is the difference between a concept submission and a full submission?

A concept submission is an overview of the proposed study that helps CSL Behring determine if it aligns with our strategic objectives. It is a simplified version of the full IIS application form. A full application involves a complete study plan and a detailed itemized budget submitted for review and consideration.

How long does the concept review process take?

Concepts are reviewed as they are received. Your Medical Science Liaison will be able to provide you with an estimated response time for concept approval.

How long does the full submission review process take?

Full submissions are reviewed on a monthly basis and you will be contacted when the CSL Behring Review Committee has arrived at a decision. Decisions are based on medical and scientific value in addition to current resources and research priorities.

How will I be notified of acceptance/rejection?

You will be contacted by your regional Medical Science Liaison or Medical Therapeutic Area Director regarding the status of your concept or application.

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