March 2020
IRB Quarterly News
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IntegReview IRB, like the general public, is concerned about the growing spread of the Coronavirus and we understand that many may be concerned about the status of their research participants/site staff safety, welfare, or the implication on study recruitment or conduction. This is a fast-evolving situation and IntegReview is continuing to answer questions surrounding the conduction of research studies with our clients.
Due to this pandemic, we understand that changes may be necessary in your IRB-approved research that will require initiation without IRB approval to eliminate apparent immediate hazards to the research participants. In keeping in line with our Company policies and Federal regulations, please report these necessary changes
promptly
to IntegReview for IRB review.
We want to reassure you that IntegReview IRB has a business continuity plan in place to ensure that there is no disruption in the services we provide to you. IRB meetings will be planned as scheduled and meeting deadlines will remain the same as indicated on our website [
click here to view Meeting & Submission Deadlines
].
If you have any questions, please contact Melanie Flores, IntegReview’s Vice President of Compliance, at
mflores@integreview.com
or call (512) 326-3001, ext. 209.
To stay up-to-date:
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IntegReview IRB is happy to work with your team on scheduling virtual auditing and one-on-one video business meetings due to any travel restrictions.
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"March" Into these Important Days To Remember
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March 8th was
International Women's Day
, celebrating the theme, "I am Generation Equality: Realizing
Women's
Rights". This year's theme is aligned with UN Women's new multi-generational campaign,
Generation Equality
, which marks the 25th anniversary of the Beijing Declaration and Platform for Action.
IntegReview IRB is a woman-owned business and this International Women's Day we celebrated all of the fabulous women at IntegReview IRB!
Here are just a few faces....
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March 12th is
World Kidney Day
, to raise awareness of the increasing burden of kidney disease worldwide and to strive for kidney health for everyone everywhere. Specifically, the 2020 campaign highlights the importance of preventative interventions to avert the onset and progression of the disease.
Kidney disease currently affects around 850 million people worldwide; one in ten adults have chronic kidney disease. This disease can be prevented and progression to end-stage kidney disease can be delayed with appropriate access to basic diagnostics and early treatment.
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There are several [Draft] Guidance Documents that have been recently published by the FDA that might be of interest to Sponsors, Research Sites and IRBs. Each Guidance Document is linked below to give you full access to the information.
The purpose of this guidance is to provide information to sponsors regarding the submission of an initial pediatric study plan (iPSP), as required by section 505B(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for oncology drugs only. Specifically, this guidance provides FDA’s current thinking regarding iPSPs for oncology drugs in light of the amendments to section 505B of the FD&C Act (also referred to as the Pediatric Research Equity Act, or PREA) made by section 504 of the FDA Reauthorization Act of 2017 (FDARA).
March 2020
This guidance includes recommendations for including an adequate representation of older adults in cancer clinical trials to better enable evaluation of the benefit-risk profile of cancer drugs in this population. The guidance emphasizes the particular importance of including adults over age 75 years in cancer clinical trials.
March 2020
This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These recommendations pertain to the format of content contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) submitted to the Center for Drug Evaluation and Research (CDER) or to the Center for Biologics Evaluation and Research (CBER).
[comments accepted through 05/11/2020]
March 3, 2020
The FDA is informing patients, health care providers and manufacturers about a set of cybersecurity vulnerabilities, referred to as “SweynTooth,” that – if exploited - may introduce risks for certain medical devices. SweynTooth affects the wireless communication technology known as Bluetooth Low Energy (BLE). The FDA is providing additional information regarding the source of these vulnerabilities and recommendations for reducing or avoiding risks the vulnerabilities may pose to a variety of medical devices, such as pacemakers, glucose monitors, and ultrasound devices.
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Congratulations Are In Order
To IRB Staffer!
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Congratulations on Heather's February Promotion!
Former
: Senior Quality Control (QC) Associate
New
: Quality Control Supervisor - In this new role, Heather will be overseeing the work of the QC Team in the Regulatory Compliance Dept., where she will apply her 7 years of industry experience and regulatory knowledge to successfully guide her team.
Heather was also the recipient of our Q1 S.T.A.R Award!
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!
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New Decision Tool Uses the
Revised Common Rule Requirements
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The Office of Extramural Research (OER) has developed a quick decision tool to assist you with determining if your research involves human subjects, may be considered exempt from Federal regulations, or is not considered human subjects research.
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Grizelda Gonzales
Quality Assurance (QA) Associate
As a QA Associate, Grizelda performs quality assurance of study-related documents in alignment with government regulated guidelines to assure the protection of human subjects involved in clinical research prior to IRB review/meetings.
Grizelda is a mother of 3 and enjoys making family memories with her husband, kids and dog, Rocky. She also LOVES to volunteer at her home parish, Prison Ministry, and serve others in need.
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Kate Bode
Quality Control (QC) Associate
As a QC Associate, Kate 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.
When Kate is not reading ICFs you can find her spending time with her husband, 2 middle-school daughters, 2 cats and 1 dog. She also enjoys gardening, hiking, and studying weather apps.
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Industry Workshops & Continuing Education
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IntegReview IRB Would Love To Meet You!
The IntegReview Team is still planning to attend the following upcoming conferences at this time and would love the chance to meet you.
Washington, DC
June 15-17
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Free Online Training:
PROVIDER
:
Multi-Regional Clinic Trials (MRCT)
The MRCT Center has developed a free, self-paced introductory course consisting of 10 modules that reflect the (ICH) Guideline E6(R2): Guideline for Good Clinical Practice (GCP). This course is an "ICH Recognized Training Program" and a certificate of completion will be provided.
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If you love mint chocolate chip ice cream, you will
LOVE these cookies! Perfectly festive for your upcoming
St. Patrick's Day celebration!
Mint Chocolate Pudding Cookies
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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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