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Quarterly IRB Newsletter
April 2015
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It is our commitment to provide exemplary protection to subjects while overseeing your research project.
We pledge to do everything possible to earn
the respect and trust of our customers
while delivering a service that exceeds
customer expectations.
IntegReview IRB has daily meetings and offers a 2-day turnaround following each meeting and reviews
research conducted in the USA, Canada,
Latin America and Japan.
Contact us today to discuss your upcoming IRB needs.
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 IRB Oversight
in Japan
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Effective March 19, 2015, IntegReview extended its
IRB
oversight to sites located in Japan. This review
applies to research that is governed by a U.S.
federal agency. A local Consultant will be utilized to
assist in the IRB review.
Call us to learn more about this new service. Our QA Department staff is happy to assist you with your Japanese submissions.
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 "Draft" FDA Guidance - Use of Electronic Informed Consent in Clinical Investigations
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This draft guidance document, distributed in March 2015, provides recommendations for clinical investigators, sponsors, and IRBs on the use of electronic media and processes to obtain informed consent. FDA's requirements for electronic records/signatures, informed consent, and IRBs are set forth in 21 CFR parts 11, 50, and 56, respectively. The information presented to the subject, processes used for obtaining informed consent, and documentation of the electronic informed consent (eIC) must meet the requirements of these and other applicable regulations.
Stay tuned for any potential IntegReview policy changes related to eIC.
To review the draft guidance in its entirety CLICK HERE.
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| Meet the IRB Staff ---------------------------------------------  Lynn Goldman, CCRP Operations Manager Lynn oversees the day-to-day operations of the IRB review process to ensure compliance with federal regulations, IntegReview SOPs, and the protection of human subjects. Additionally, she is available on our membership roster as an alternate scientific IRB member. Outside of IntegReview, Lynn is a judge and official for U.S. Figure Skating, traveling throughout north America judging events from beginner to Olympic and World champions. Lynn is also a member of the Board of Directors and oversees committees responsible for the domestic technical rules of the sport. During her free time, she enjoys reading, watching movies and just being at home.
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|  Charlotte Betteridge Quality Control Associate Charlotte's focus is on the quality control of regulatory documents to ensure compliance with federal regulations following the review by the IRB committee. She is from London, England, and graduated from Texas A&M University with a degree in Biomedical Sciences. Charlotte spends a lot of time caring for her young, gorgeous nieces and her interests include traveling, spending time outdoors and with friends and family. |
 IRBManager and Submission Tips!
Tip #1
- If you need to see forms that have been started, but have not been officially submitted to the IRB for processing, do the following: On your IRBManager Home page, under section 'xForms (# Active)' click on the link that reads, 'You have # unsubmitted xForms'.
Tip #2- Advertisements and recruiting materials, whether on a web page, Facebook page, Craigslist or in a newspaper, are considered materials for IRB review and should be included with your submission.
Tip #3 - The term 'Expedited' is a FDA classification by which the study review is done by a single IRB reviewer. Before submitting a new study, review the 'Exempt vs Expedited Determination Guide' under 'Useful Links' on your IRBManager Home page to determine if your study qualifies.
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2015 Networking & Training Opportunities
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Rick Clemens
Vice President of Business Development |
Sarah Attwood
Associate Director
of Business Development
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Here is a list of where IntegReview IRB will be throughout the year. We hope to meet you in person! If you are interested in arranging a meeting with our Business Development Group during these events, please send us an e-mail to
[email protected].
April 25-27: ACRP Conference; Salt Lake City, UT (Silver Sponsor, Exhibitor)
May 17-19: MAGI East Conference; Arlington, VA (Sponsor, Exhibitor)
Please attend the session, "The Five Things We Can't Seem to Get Right",
where our IRB Member, Marcy Goodfleisch, will be a panel presenter.
June 15-17: DIA Conference; Washington, DC (Exhibitor)
Sept. 18-20: SoCRA; Denver, CO (Exhibitor, Training)
October 9-11: Site Solutions Summit; Amelia Island, FL (Exhibitor, Training)
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IntegReview IRB / 3001 S. Lamar Blvd., Suite 210 / Austin / TX / 78704
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