Sponsor FAQs
Q. How do I submit a study to Liberty IRB?
A. Submission to Liberty IRB is a quick and easy process. Simply click under each category in the drop down link to forms. A submission checklist is provided for your ease of use. All these forms must be completed before submitting them to LIRB for review. Please feel free to contact us with any concerns you may have.
Q. How often does Liberty IRB meet?
A. LIRB meets weekly and can accommodate any deadlines you may have. Simply submit your documents by Friday one week prior to the meeting date. See Meeting Calendar.
Q. How do I securely submit documents online to Liberty IRB?
A. LIRB has a secure portal for submission of sensitive documents. Please contact the Project Management Team for a secure log in name and password.
Q. What is the submission deadline for a new study?
A. New studies must be submitted by Friday for review the following Thursday. Be sure to include all items listed in the Submission Checklist.
Q. What is your turnaround time?
A. LIBERTY IRB reports all board decisions within two business days of the board meeting. Documents can be sent electronically, by mail or fax.
Q. What should I do when I need my consent revised?
A. Consent revisions should be submitted electronically (email). Please clearly indicate all changes and include a cover letter explaining the rationale for change.
Q. What is HIPAA?
A. HIPAA stands for Health Insurance Portability and Accountability Act of 1996. It is also referred to as The Privacy Rule.
Q. As an investigator, what do I need to do to be HIPAA compliant?
A. If you as an investigator are considered a HIPAA covered entity, you will need to ensure that you have measures in place to maintain the privacy and confidentiality of protected health information. See HIPAA Authorization Form.
Q. What are Liberty's requirements for reporting adverse events?
A. All serious adverse events and any unexpected drug or device related adverse events must be reported to LIRB within 5 business days.
Q. What Protocol Deviations must Liberty require to be reported?
A. Protocol Deviations, which in the view of the sponsor or investigator may affect the rights, safety and welfare of human research subjects, must be reported to LIRB.
Q. How do I renew IRB approval for a study?
A. A Continuing Review Form must be completed and submitted along with a copy of your most recently approved consent form. Please click under forms to find this information.
Q. How do I submit a Protocol Amendment?
A. Protocol Amendments should be submitted with a cover letter signed by the investigator. A summary of changes should also be included to facilitate board review. Clearly indicate if a consent change is needed. Amendments can be submitted via fax, electronically or by mail.
Q. Will a Sponsor/ CRO receive an approval letter?
A. The original determination letter will be sent to the investigator; however, Liberty IRB will be happy to send copies to the Sponsor or CRO upon request.
Q. What is Liberty's policy for reporting IND Safety/ Med Watch reports?
A. IND Safety/ Med Watch reports should be submitted to Liberty IRB within 5 business days of investigator's receipt. All reports will be acknowledged and faxed back to you.
Q. If I have questions about an existing study, is there someone I can contact?
A. Your assigned Project Management Team will be happy to assist you with any questions or concerns you may have.
Q. How will I be notified that my submission is complete?
A. You will be sent an email that your submission packet has been received by Liberty IRB. If there is missing documentation, your project manager will contact your site immediately. Otherwise you should expect your site to be reviewed within 7 business days.
Q. What can an IRB review by Expedited Review?
A. See Federal Register Notice November 9th, 1998. This information can provide you with guidance for determining if your submission meets expedited review criteria. Appendix D Page 1-8
Q. Do you need approval for telephone scripts?
A. Yes, you need approval on all study related materials.
Q. Do you accept electronic submissions?
A. Yes.
Q. Is Liberty IRB accredited?
A. Liberty IRB is currently undergoing IRB accreditation through AAHRPP, Association for the Accreditation of Human Research Protection Programs.