October 2019
IRB Quarterly News
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National Women's Small Business Month
October is
National Women's Small Business Month
, a time to celebrate the growth and accomplishments of female entrepreneurs and the vital role they play in our economy.
Join IntegReview IRB in the movement of support for Women Owned businesses during
National Women's Small Business Month
, and beyond.
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Breast Cancer Awareness
Month
For more than 30 years, October has been designated as Breast Cancer Awareness Month. Thankfully, death rates from this dreadful disease have decreased over time because of heightened awareness that's led to increased screening and improved treatment options, but there are still thousands of women who don't have access to basic care, like annual mammograms. You can join in 'Helping Women Now' by making a gift today - just click on the pink ribbon!
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Congratulations To (more)
2019 IRB Staff Promotions!
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Francine Lopez, CCRP
Former
: IRB Coordinator/Co-chair of Friday Board
New
: IRB Operations Supervisor - In this new role, Francine will be overseeing the work of the IRB Administrative Associates, where she will apply her 11 years of IRB and regulatory knowledge & expertise to successfully guide her team.
Jenna Rozacky, CCRP
Former
: Assistant IRB Coordinator
New
: IRB Coordinator/Co-chair of Friday Board - In this new role, Jenna becomes a voting member of the board and will be responsible for facilitating a weekly IRB meeting and the day-to-day administrative activities that support the board.
Jessica Villegas
Former
: Quality Assurance (QA) Assistant
New
: Quality Assurance (QA) Associate - In this new role, Jessica will now embark upon more responsibility within the Regulatory Compliance department and be responsible for performing QA on regulatory documents prior to IRB review.
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Outbreak of Lung Injuries Associated
with Vaping
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The Center for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the state authorities have been investigating reports of serious lung injury associated with “vaping products,” with several incidents resulting in death. Reports indicate that users may have been vaping THC-based products, other cannabis-based products, nicotine-based products or a combination of those products. Thus far, neither CDC nor FDA has identified a specific product as causing these lung illnesses and the investigations remain ongoing. Visit the CDC's website at
http://www.cdc.gov
, where information is
updated weekly
.
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Mobile Apps and Research
FDA Guidance
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The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of software applications and mobile apps, the rapid pace of innovation, and their potential benefits and risks to public health. And so last month, the FDA published six Guidance documents on the subject of mobile apps used in research. The list of each Guidance is below, click on the title to view each document in its entirety.
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How Can Sponsors Help Improve the Design and Conduct of Research?
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Researchers can engage patients during the study design phase, or protocol development, as early as the protocol concept, and partner with patients in creating patient-centric clinical studies by use of the P-PET.
The
Patient Protocol Engagement Toolkit (
P-PET) is a comprehensive set of materials that is designed to improve patient experience and reduce patient burden as a study participant.
Components of the P-PET include:
- User Guide: The User Guide supports sponsors in (1) understanding the value of implementing the P-PET in their respective clinical studies, (2) understanding how to leverage the P-PET and implement it in a clinical study and share ideas and best practices on how to have meaningful discussions with patients, (3) socializing with stakeholders to seek greater support as needed and (4) providing example case studies.
- Resource Guide: A set of sample questions for consideration during an engagement with patients. Examples of visual aids are provided to facilitate clear communication of study design and protocol-related concepts to the patients.
- Templates: Templates to help support engagement discussions with patients and provide feedback to both the study teams and patients.
Click Here
to learn more and to access the toolkit.
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Joanne Mercado
Quality Control (QC) Assistant
As a QC Assistant, Joanne assists the Regulatory Compliance Department with the quality control on selected regulatory documents in alignment with Company policies/procedures and government regulated guidelines, with special emphasis placed on enhancing and maintaining the quality of services provided to our clients.
Joanne loves spending time with her family watching horror movies, magnet fishing, playing "What Do You Meme" every Turkey Taco Tuesday, and playing with her 4 fur buddies at the park. Her favorite all time movie is Purple Rain, which she re-watches at least once per week!
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Kimberly Chaison
Quality Control (QC) Associate
As a QC Associate, Kimberly 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.
In Kimberly's personal time, she enjoys reading and writing, loves to travel and likes to stay active by ice skating and doing yoga.
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Industry Workshops & Continuing Education
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We hope that you can take the opportunity to hear IntegReview's Senior Consultant, Ernie D. Prentice, Ph.D., speak at one of these two upcoming conferences.
Las Vegas, Nevada
October 20-23, 2019
Boston, Massachusetts
November 18-20, 2019
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OHRP Free Webinar
As Part of OHRP's
2019 Exploratory Workshop Series
, the webinar on "Privacy and Health Research in a Data-driven World" is now available to the public.
All of the workshops in this series meet the SoCRA & CIP recertification guidelines and are eligible for a maximum of 6.5 hours of credits.
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IntegReview IRB Would Love To Meet You!
The IntegReview Team will be attending the following upcoming conferences and would love the chance to meet you.
San Antonio, TX
November 5, 2019
Minneapolis, MN
November13-15
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With all of the sweet treats surrounding us this time of year,
this savory, festive treat is sure to be a favorite at your Halloween party or Thanksgiving gathering!
Pumpkin-Shaped
Cheese Ball
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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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