Quorum Review Inc. - Additional Services - IRB determination

By: Quorum Review  09-12-2011
Keywords: Study Support

Q.    What is an Exemption Determination Request? >>

Some research activities that involve human subjects may be exempt from IRB review under certain conditions pursuant to 45 CFR 46.101(b) (federally funded projects), 21 CFR 56.104(d) (FDA regulated studies), and the Tri-Council Policy Statement (TCPS 2), Article 2 (Canadian Research). An applicant may therefore apply to Quorum Review for an exemption determination.

Q.    How can I determine if I am exempt from review? >>

If you would simply like more information regarding how to make an exempt determination please refer to the Quorum handbook.

Q.    How do I submit an Exemption Determination Request to Quorum? >>

Quorum accepts Exemption Determination Request via the

Quorum Review

Initial Study Support Department

1601 Fifth Ave., Ste. 1000

Seattle, WA 98101

Fax: 206-448-4193

Q.    Which form should I complete if I want to submit an Exemption Determination Request? >>

For an exemption determination, the Quorum Review Request for Exemption Determination Form should be completed. Additionally, a copy of the final protocol or research proposal is required.

Q.    Who should I contact if I have questions about completing an Exemption Determination Request? >>

Keywords: Study Support

Other products and services from Quorum Review

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Quorum Review Inc. - Additional Services - prereview

This conference call will involve the following parties: a sponsor representative and other pertinent parties to help give general feedback about the protocol or consent form, the IRB Chairman, and a representative from Quorum's Study Management, Initial Study Support, and Regulatory departments.


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Quorum Review Inc. - Additional Services - services

For studies with tight timelines, this service can often save valuable time during consent form negotiation. Quorum has built out many processes to better accommodate the unique needs of institutions. Quorum Review IRB is a full-service independent review board.


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Quorum Review Inc. - Additional Services - federally funded studies

Certificates of Confidentiality allow investigators to refuse to disclose identifying and sensitive information obtained as part of research, in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.


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Quorum Review Inc. - Additional Services - institutional partnerships

IRBs within institutions are looking for ways that they can expand their current capacity and improve their review cycle timelines without increasing costs. Some institutions are looking for secondary supplier alternatives while others are looking to focus on research and outsource the IRB function all together.


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HIPAA

For research recruitment purposes, an investigator may wish to use already collected PHI in order to contact potential participants or may collect and record PHI via telephone screens before the potential research participants visit the research site (called a "Partial Waiver". It may not be practical for an investigator to obtain a signed HIPAA Authorization prior to the use and disclosure of a participant’s PHI.


09-12-2011

Quorum Review Inc. - Additional Services - translation

When submitting a new study to Quorum, sponsors, CROs and single sites may request our translation services in the Central Study Questionnaire, Single Site Study Questionnaire, or Principal Investigator Generated Study Questionnaire. When you select Quorum to manage your translations in addition to reviewing your study, we can ensure quality standards are met and translations are completed in a timely manner.