Quorum Review Inc. - Additional Services - services

By: Quorum Review  09-12-2011
Keywords: Consent Form

Quorum Review IRB is a full-service independent review board. Here are some of the additional services we provide:

  • Quorum has built out many processes to better accommodate the unique needs of institutions.

  • For studies with tight timelines, this service can often save valuable time during consent form negotiation.

  • Quorum's pre-review consultation provides an opportunity for researchers to obtain feedback prior to IRB review.

  • Keywords: Consent Form

    Other products and services from Quorum Review

    09-12-2011

    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.


    09-12-2011

    Quorum Review Inc. - Additional Services - IRB determination

    Some research activities that involve human subjects may be exempt from IRB review under certain conditions pursuant to 45 CFR 46.101(federally funded projects), 21 CFR 56.104(FDA regulated studies), and the Tri-Council Policy Statement (TCPS 2), Article 2. Q. Who should I contact if I have questions about completing an Exemption Determination Request. An applicant may therefore apply to Quorum Review for an exemption determination.


    09-12-2011

    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.


    09-12-2011

    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.


    09-12-2011

    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.