In September, Quorum's New Services, Forms and Policies Will Help Sponsors,
CROs, and Sites Work Together Seamlessly
On September 12th, Quorum Review will launch changes to the services, forms and
policies used by sponsors, CROs, and investigators. These changes have been
designed to make it even easier to get studies started and completed quickly
and efficiently with Quorum Review. New sponsor-related services include more
frequent status updates, approval of participant study materials, revised study
closure procedures, and a Quorum Handbook.
The following is a description of some of the new services, forms and policies
to expect in September:
More Frequent Status Updates
Quorum understands that sponsors want to track site submissions closely. In
order to facilitate communication among the sponsor, the site, and the IRB,
Quorum will submit status update reports to the sponsor twice weekly. These
updates will provide you with information regarding the receipt, review and
status of your investigator submissions, including any missing information that
may delay IRB review. Sponsors will be able to retrieve these updates by going
to the Quorum Web Portal. Contact our Customer Relations
department by phone (206.448.4082) if you do not have access to this secure
area.
Approval of Participant Study Materials
In order to help investigators and sponsors track the approval of participant
study materials more effectively, Quorum will provide approval notification for
these items. This approval will be provided either in conjunction with initial
review or individually when submitted separately, with a copy provided to the
sponsor. This will ensure that investigators have documentation of IRB review
for participant study materials, such as participant diaries and
questionnaires. Additional guidance regarding the documents required for review
under this category will be issued in September.
Revised Study Closure Procedures
Quorum wants to help clarify when sites should submit closing reports. To that
end, Quorum will provide clear study closure criteria in the study closing
report and in the Quorum Handbook. This should reduce the amount of follow-up
necessary to complete the required documentation. In an effort to facilitate
communication among the clinical study team members, Quorum will issue
acknowledgement letters to sponsors, CROs, and sites regarding the closure of
sites.
Working with Quorum
A new Quorum Handbook will be issued this fall to help investigators, sponsors
and CROs better understand Quorum's policies and procedures. This handbook will
include information on Study Start-up, Ongoing Research Activities, Continuing
Review and Study Closure, as well as general information regarding Quorum
Review IRB. Quorum will understand sponsor preferences for management of the
study more clearly, through a revised Central Study Questionnaire.
What's Next?
Quorum Review will provide you with the information and tools you need to make
a smooth transition to our new services, forms and policies. As we approach the
September 12th launch, you should expect:
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Updates on 'what to expect and when' via an informational pamphlet and e-mail
newsletters
-
Information regarding onsite and remote workshops provided by Quorum Review
Study Management Team
-
A launch CD that contains everything you need to get started
As always, please check our website at www.quorumreview.com
for regular updates.
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