June 2018
IRB Quarterly News
Melissa 2014

Editor's Note

IntegReview IRB prides itself on possessing the ability to provide unsurpassed guidance and education to researchers and to research staff. 

Our highly experienced and knowledgeable IRB staff goes above and beyond to assist you with your research project starting with the submission process to assisting with ethical compliance and the interpretation of federal requirements. Additionally, you can always arrange a consultation with an IRB Member when seeking guidance about your study design.

We look forward to serving your IRB needs!

Melissa Meyer, CCRP
President, IntegReview IRB
"Our new favorite IRB!"

"I wanted to thank IntegReview for their assistance with my project. Unfortunately, we were unable to enroll and I have been forced to close the study, but IntegReview made the process of completing the IRB proposal very straightforward and user-friendly. I look forward to submitting another protocol to IntegReview in the future."

"We have used IntegReview for many years on many studies and have always found them to be extremely quick to turn documents around, and there is always someone there to answer our many questions! The approval documents and ICF footers make version control easy."
CONGRATULATIONS to our S.T.A.R Award Winners starting off the year with a bang! Voted on by your peers, you are recognized for your admirable work ethic and dedication to providing excellent service!
Betty Maldonado, CCRP
Regulatory Compliance Manager
Quarter 1 S.T.A.R. Winner
Jenna Rozacky
IRB Administrative Associate II
Quarter 2 S.T.A.R. Winner
Are You Part of Our
Investigator-Site Network?  

Sponsors and CROs are using our database to find interested sites for their projects.  It only takes a few minutes, sign up today!  
What Type of Deviations Need to be Submitted
to the IRB?

IntegReview IRB requires the submission of only significant deviations.  What makes a deviation significant?

IntegReview IRB put together some Guidelines to help sites determine what types of Protocol Deviations are reportable.  View these Guidelines by clicking on the link below.
IntegReview IRB
Reporting Requirements 

While all IRBs follow federal regulations and guidelines on reportable study-related events, it is at the discretion of the IRB to interpret the timelines of when each event is required to be reported.

Please familiarize yourself with our reporting requirements by clicking on the link below to ensure you are in compliance with our policies.
House Approves
'Right To Try' Bill for Experimental Drugs 

House lawmakers approved legislation on May 22, 2018 that would allow terminally ill patients to request access to experimental drugs that have undergone early-stage clinical trials but have yet to receive approval from the FDA. The bill, which would not require pharmaceutical companies to provide the drugs, was passed by the Senate last year and now goes to the President for his expected signature.
EU General Data Protection Regulation (GDPR)

This is the most important change in data privacy regulation in 20 years...MAKE SURE YOU ARE PREPARED!  This new regulation replaces the Data Protection Directive and was enforced on May 25, 2018.  Learn more about the new GDPR by clicking on the link below.
Crock Pot Beer Chicken Taco Salad w/ Cilantro Vinaigrette
It is heating up outside, no
need to heat up the inside! 
Try this No-Oven Dinner.
Meet the IRB Staff
Victoria Govea, CCRP
Director of Operations
IRBManager Senior Administrator

Victoria's primary function as Director of Operations is to take daily leadership, management and full operational responsibility for the company operations in order to meet the targets for customer service and retention, performance standards and financial goals. 

Victoria was born and raised in Austin.  She is married with 3 children and is an avid football fan and loves to cheer on the Dallas Cowboys as well as the Texas Longhorns.
Erik Guerra, B.S.
Client Service Specialist

Congratulations to Erik as he embarks on a new career path with IntegReview as our Client Service Specialist.  Erik has many years experience in Regulatory Compliance, which will no doubt give him an edge; and emanates exemplary customer service.     

Erik enjoys spending time outdoors working in his 300 square foot garden.  He is fascinated by all things science and subscribes to several publications, catching up on reading articles when his two young daughters give him the opportunity.

Common Rule Revisions

US Federal departments and agencies have delayed the general compliance date for the 2018 Requirements for an additional six months, for the time period of July 19, 2018 until January 21, 2019. This proposed rule is intended to provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements.

IntegReview Personally Invites You
DIA Annual Conference
June 25-27, 2018
Boston, MA
Two Valuable Registration Offers Courtesy of IntegReview IRB
Booth #1606
Register now - $150 One Day Exhibit Hall Only Pass
[Update cart with Promo Code: 5902E18E before checkout]
Includes full day access to Exhibit Hall from 10:00AM-6:00PM on Monday, 9:30AM-5:00PM on Tuesday, or 9:30AM-4:00PM on Wednesday with morning and afternoon refreshment breaks.

Register now - $100 discount off the Full Annual Meeting Registration
[Update cart with Promo Code: 5902E18 before checkout]
Includes Monday Welcome Reception, admission to all sessions, exhibits, refreshment breaks, luncheons, and six months of free access to all available online presentation slides.

IntegReview IRB | 512.326.3001|  http://www.integreview.com