IRB Quarterly Update

October 2018

IRB Quarterly News

INTEGREVIEW IRB

IS GOING PINK!

In honor of

Breast Cancer Awareness Month

Editor's Note

I just love this time of year when the weather begins to cool, the leaves begin to turn beautiful colors, and the holidays start to approach us.

What else is quickly approaching?...the general compliance date of the changes to the Common Rule. We will be spending this last quarter taking a strong look at our policies and procedures to make any necessary changes to ensure our compliance before they take effect on January 21, 2019. Stay tuned for IRB changes that may affect how you submit to the IRB.

Melissa Meyer, CCRP

President, IntegReview IRB

Special 510(k) Program Pilot

On October 1st the FDA launched the Special 510(k) Program Pilot, which aims to simplify how manufacturers submit certain 510(k)s. The goal of the pilot is to determine whether updated factors for eligibility in the Special 510(k) Program will improve the FDA's efficiency in reviewing 510(k) submissions.

Learn more now about the

Special 510(k) Program Pilot.

"I want to say how THRILLED I was with the first submission experience! I love your online system. It’s so much more efficient than the process we used with the previous IRB we worked with and it allowed me to build things as I went and made it almost impossible to make mistakes. I look forward to our next project with IntegReview."

"We love working with IntegReview."

"I could never express how wonderful your team is. We enjoy working with IntegReview sooo much, if it was up to us we would always use your team. You go beyond the call of duty to assist us with anything we need. I could never thank you all enough for all of your help and assistance."

"We have worked with IntegReview since 2015, all of our contacts since then have been very helpful, professional, and prompt to respond."

Civil Money Penalties Relating to the ClinicalTrials.gov

Data Bank

In September, the FDA released a Draft Guidance on how the FDA's CDER, CBER and the CDRH will identify responsible parties who have failed to submit required clinical trial registration and/or results information or submitted false or misleading information to the ClinicalTrials.gov data bank and how they decide to seek civil money penalties.

READ THE FULL

GUIDANCE DOCUMENT

Artificial Organs for Biopharma Research and More...

Between advances in stem cell research—and spinach leaves—and 3D bioprinting, the future looks very near for developing living tissues for research and transplants.

As published in July 2018 by BioSpace, there has been recent coverage of 3D bioprinting and how it has the potential to create a brave new world of printed organs to be used in biopharma research and maybe someday to even be used in organ transplants.

EXPLORE MORE

IntegReview IRB

Career Center

IntegReview IRB is continually growing and we are currently hiring for the following positions:

IRB Administrative Associate II

Quality Assurance (QA) Assistant

Quality Control (QC) Assistant

To review job descriptions and our application process CLICK HERE !

#womanownedbusiness

#jointheteam

NIH Releases Draft Behavioral and Social Clinical Trials Template for Public Comment

This new template was created to guide investigators through the systematic development of a comprehensive clinical protocol. The template retains much of the content and structure of the NIH-FDA Phase 2 and 3 IND/IDE clinical trial protocol template, but has been tailored specifically for studies involving a social or behavioral intervention.

Find out more, along with instructions to submit comments.

Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics

Guidance for Industry

In August, the FDA released a Draft Guidance on first-in-human expansion cohorts in oncology trials. This guidance provides FDA’s current thinking regarding:

(1) characteristics of drug products best suited for consideration for development under a multiple expansion cohort trial;

(2) information to include in investigational new drug application (IND) submissions to support the use of individual cohorts;

(3) when to interact with FDA on planning and conduct of multiple expansion cohort studies; and

(4) safeguards to protect patients enrolled in FIH expansion cohort studies.

GET THE FULL GUIDANCE DOCUMENT

Pink Lady Squares

GET THE RECIPE!

Meet the IRB Staff

Brady Mayfield

IRB Administrative Associate II

Brady‘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.

Brady has many interests such as running, weight lifting & working out, camping, reading, politics, podcasts and history. He also likes hanging out with friends and watching old and/or obscure movies.

Cindy Prakop

Senior QC Associate

As a Senior QC Associate, Cindy 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. As a Senior level employee, Cindy assists in training team members and in improving the training program related to regulatory compliance.

Cindy, born in Holland, MI, was raised in Austin since she was 2. She and Ben have been married for 14 years and they have 3 kids, Bryce (13), Payton (23) and Beaux (their mini Australian Shepherd). She enjoys spending time with her family and friends and doing DIY projects and they are soon-to-be Grandparents!

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 the movement of support for Women Owned businesses during National Women’s Small Business Month , and beyond.

Quick Links

IRBManager portal

How to Submit a Study

Key Management

Where IntegReview IRB will be this year

STAY CONNECTED

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