September 2020
IRB Quarterly News
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IntegReview IRBs attention is focused on navigating the challenges presented by the COVID-19 pandemic, most importantly, ensuring the health and safety of our employees, study participants and clients.
We are coordinating closely with Sponsors, CROs, and Researchers to minimize study disruption where possible.
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IntegReview Receives Full
AAHRPP Reaccreditation
September 15, 2020
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IntegReview CEO, Melissa Meyer, released a Press Release on September 16th announcing the IRB's full reaccreditation from AAHRPP, effective through September 15, 2025.
Not only did AAHRPP not provide observations or require changes for improvement, they commended IntegReview IRB on a very successful HRPP and the outstanding synergy between their IRB staff and IRB members.
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Congratulations On a
Well-Deserved Promotion!
Lynn Goldman
Director of Client Services
Lynn's 13 year career with IntegReview started as an IRB Co-chair/Coordinator for one of the IRB Committees. In 2014 she received a promotion to Operations Manager, where she managed the department responsible for processing IRB documents pre/post IRB review. Prior to coming to IntegReview, Lynn worked at the Children’s Hospital of Austin as a Registered Dietitian, Certified Diabetes Educator, Certified Pediatric Nutrition Specialist and a Research Coordinator. Her clinical and research experience includes diabetes, cystic fibrosis, inborn errors of metabolism and general pediatric nutrition. Outside of the office, Lynn serves as an national level official for the U.S. Figure Skating Association and currently sits on their Board of Directors as the Athlete Services Group Coordinator, overseeing athlete development programs as well as rules and regulations of the sport. Lynn is a sharp talent and her transition from Operations to the Client Services/Business Development Department will be a seamless one.
Join us in welcoming Lynn into this new and exciting role! If you would like to send her a congratulatory message, just click on her photo.
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"Listen In"
Free Webinar Replays
with IntegReview IRB's
President, Melanie Flores
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"IRB Perspective on Decentralized Clinical Trials"
[July 2020]
Melanie Flores, CIP, CCRP sits down with Curebase CEO, Tom Lemberg, for a candid conversation on the IRBs perspective on decentralized research.
In this webinar, Melanie shares from her 20+ years of experience how the perspectives and considerations for decentralized clinical trials has evolved, and what to consider for future studies, as technology progresses, in protecting patient’s rights.
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"Evaluating Global eConsent Use Cases"
[September 2020]
Presenting with snapIoT, LEO Pharma, and Studies&Me, Melanie Flores, CIP, CCRP joins a webinar discussion on evaluating global eConsent.
In this webinar, Melanie provides the IRBs perspective on the regulatory and IRB requirements on eConsent.
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U.S. Food & Drug
Administration Guidance
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There are several Guidance Documents that have been recently published by the FDA that might be of interest to Sponsors, Researchers and IRBs. Each Guidance is linked below to provide you full access to the information.
July 23, 2020
FDA is is proposing to establish requirements for the deadline and contents of submission of an annual summary. This proposed rule, if finalized, would implement the statutory requirement under provisions of the Right to Try Act for submission of an annual summary by sponsors and manufacturers who provide an eligible investigational drug for use by an eligible patient.
August 2020
Males have historically been excluded from clinical trials of breast cancer drugs because breast cancer in males is rare. This exclusion has resulted in limited FDA-approved treatment options for males with breast cancer. Treatment strategies for males with breast cancer are not based on data from prospective, randomized clinical trials. Rather, clinical management of male breast cancer is generally based on clinical experience with breast cancer in females and data from studies conducted in females with breast cancer. This guidance provides recommendations to sponsors regarding the development and labeling of cancer drugs, including biological products, regulated by CDER and CBER for the treatment of male patients with breast cancer.
August 2020
This guidance document provides answers to the following questions:
• How do the CDER, CBER, and CDHR (hereafter, "Center or Centers") intend to identify whether responsible parties have failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank or submitted false or misleading information to the data bank, or whether submitters have failed to submit to FDA the certification required by section 402(j)(5)(B) of the PHS Act4 or knowingly submitted a false certification to FDA?
• Under what circumstances may a Center decide to seek civil money penalties against a responsible party or submitter?
• What procedures apply when a Center seeks civil money penalties?
• What civil money penalty amounts may be assessed for (1) failing to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank, (2) submitting false or misleading information to the data bank, (3) failing to submit the required certification to FDA, or (4) knowingly submitting a false certification to FDA?
On August 23, 2020, FDA issued an Emergency Use Authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the authorization, COVID-19 convalescent plasma may also be used under an investigational new drug application (IND). For the purposes of this guidance, the term “COVID-19 convalescent plasma” refers to the convalescent plasma authorized under the EUA, while the term “investigational convalescent plasma” refers to convalescent plasma that does not meet all the conditions of the EUA and/or is being used under an IND.
FDA is issuing this guidance to help drug and biological product manufacturers during the COVID-19 public health emergency plan and prioritize current good manufacturing practice (CGMP) activities as they transition from operations impacted by the public health emergency to normal manufacturing operations. This guidance describes how to evaluate and prioritize the remediation of CGMP activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply.
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Anthony Mercado, CCRP
Quality Control (QC) Associate
As a QC Associate, Anthony provides quality control on study-related documents in alignment with government regulated guidelines in regards to the protection of human subjects involved in clinical research, with special emphasis placed on enhancing and maintaining the quality of services provided to our clients.
Anthony's interests include photography, woodworking, and kayaking. He loves dogs and has three pups, Pablo, Bella, and Ollie.
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Andrew LeRoy
IRB Administrative Associate II
Andrew's responsibility as an IRB Administrative Associate II is to assist the IRB committees by processing study-related material following initial IRB approval in alignment with government guidelines and accreditation standards.
Andrew is a big fan of Star Wars and the Dallas Cowboys. In his spare time he volunteers with the FIRST Tech Challenge, which is a robotics competition for youth.
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CONGRATULATIONS TO OUR S.T.A.R AWARD WINNER!
Our quarterly S.T.A.R. Award Winners are voted on by their peers, and are recognized for their admirable work ethic and dedication to providing excellent service!
Leila Terada
Assistant IRB Coordinator
Quarter 3
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IntegReview IRB
Career Center
IntegReview IRB is busier than ever and continually growing and we are currently looking for highly motivated people that have the ability to multi-task in a fast-paced environment.
Operations Dept.:
IRB Administrative Associate I
IRB Administrative Associate II
If you happen to know someone in the Austin area looking for work please send them our way.
To review job descriptions and our employment application process
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Look for it October 1st!
To best collaborate with our clients IntegReview has developed an IRB Handbook. This Handbook is being developed to provide instructions on the IRB's processes and requirements to Sites, Sponsors, CRO's and SMO's.
The IRB Handbook will be made available On October 1st in IRBManager > Useful Links.
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Butternut Squash & Red
Lentil Curry Soup
Fall time is the perfect time for soups! The butternut squash makes this soup a healthy option, and the curry makes it extra tasty!
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Let Us Know How We Are Doing
If you are impressed with our business, services, and/or IRB Staff we would be proud to have a review from you on Google Review!
We very much appreciate your business!
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