In September, Quorum's New Services, Forms and Policies Will Help You Get the
Job Done
On September 12th, Quorum Review will launch changes to the services, forms and
policies used by our investigators. These changes have been designed to make it
even easier to get studies started and completed quickly and efficiently with
Quorum Review. With respect to services, we are especially excited to be able
to offer customers a web-based Site Information Questionnaire with on-line
guidance for completion. We also will offer a new Quorum Handbook that explains
our policies and procedures, including our safety reporting guidelines.
Finally, we are revising our forms to be easier to use. In a number of areas
the forms will seek more information in order to address evolving regulatory
and industry standards, but we have worked hard to retain the simplicity and
ease of use that our customers expect from Quorum Review.
Here is a sampling of the new services, forms and policies to expect in
September:
Revised and Web-based SIQ
In response to customer demand, in September Quorum will offer a web-based
version of the Site Information Questionnaire (SIQ), the initial submission
form completed by a researcher. The web-based version of this form will include
the following features:
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Guidance at your fingertips. If you don't know how to answer a particular
question, built-in help text and tips for completion are available within the
form itself.
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Pre-population for repeat submissions. If a researcher has completed Quorum's
web-based SIQ once, the researcher can obtain a partially pre-populated SIQ
each time the researcher re-applies to Quorum.
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Library of completed SIQs. As a researcher completes multiple SIQs, a reference
library of all completed forms will be available for retrieval.
Look for more information regarding how to access this on-line service between
now and September.
Site Support Team
If you need assistance with filling out any Quorum form or require an
explanation of a Quorum policy, please call for assistance. A team of trained
and experienced employees will help you complete your submission documentation
accurately and expeditiously. If the site support team cannot answer your
questions, they will make sure to find the right person immediately within
Quorum who can.
Quorum Handbook
Quorum's new handbook explains our policies and procedures. You'll find
guidance in completing the SIQ, safety reporting guidelines and guidelines for
submitting participant study materials and advertisements for review.
Quorum's handbook will be available on Quorum's website. In early September we
also will send our existing customers a CD-rom with a copy of the handbook.
Finally, you always can contact us if you would like a hard copy of the
handbook.
New Prompt Reporting Deadline (10 Days) and Guidelines
Quorum will implement the following changes to the guidelines for prompt
reporting of safety information:
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Better definition of the events that must be promptly reported. Look for a
one-page summary circulated with each Notice of Approval. In addition, look for
a presentation explaining safety reporting requirements on our website with our
September 12th launch.
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Fewer events will have to be reported. Quorum only wants to receive reports of
serious and related adverse events, major protocol deviations and certain other
possible unanticipated problems.
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New reporting forms will collect all of the information that Quorum needs.
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A longer reporting period. Reportable events will have to be reported within
ten days of discovery by the researcher, not three days.
More Guidance for the Submission of Recruitment Materials and Participant Study
Materials
In the new handbook and on the website, Quorum will provide better guidance
about the materials that need to be submitted to the IRB for review, such as:
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Television, radio or print advertisements
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Study-specific instructions
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Study-specific consent form information
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Study-specific newsletters
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"Dear patient" letters
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Materials developed by the sponsor, such as protocol-required diaries or
questionnaires.
Quorum also will provide better guidance about what materials don't have to be
submitted to the IRB for review, such as:
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General treatment consent forms
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Doctor-to-doctor letters
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Cookbooks or articles prepared by third parties.
More Guidance in the Use of LARs
Quorum no longer will include a signature line for legally authorized
representatives (LARs) on each and every consent form. Instead, a site will
have to explain on the SIQ the processes it will use for securing the effective
consent of an LAR before Quorum will issue a consent form with an LAR signature
block.
Sponsor Involvement in Site Closures
After your site has completed a study and submitted a closing report to Quorum,
Quorum will send a confirmation letter both to you and the sponsor. This
additional confirmation step should help avoid accidental closures.
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
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Information regarding onsite and remote workshops provided by Quorum Review
Study Management Team
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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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