IntegReview Ethical Review Board
Newsletter 
Volume 1 - Issue 2 December 2009
In This Issue
IntegReview Policy Change
Measuring IRB Performance
Impressive Quality
4th Annual Site Solutions Summit
Upcoming Events 2010
IntegReview Policy Change
Expedited Review of Investigators
 
Effective April 13, 2009, IntegReview will review
Investigators being added to a currently approved research study using an expedited review procedure as long as the research involves no more than minimal risk.  If upon review, the IRB determines that the submission is not considered minimal risk or has concerns regarding the investigator/site documents the IRB will require review by full board.
'Tis the Season...
 
Happy Hanukkah
 
 Merry Christmas
 
Happy Kwanzaa
 
Happy New Year
 
IntegReview wishes you and your family a healthy and prosperous year 2010!
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It is our commitment to provide exemplary protection to subjects while overseeing your research project as well as providing you with outstanding customer service. 
 
Electronic submission forms coming in Quarter 1, 2010!
Measuring IRB Performance
                   
IntegReview provides unsurpassed IRB services without compromising compliance or quality of service.  Here are some performance metrics that support strategic and operational decisions to expedite the QA and IRB review time. 
 
This applies for all new study, Additional PI and Continuing Review submissions:
 
Average Review Time
 
Full board review items = 8 calendar days
Day 1-2 = submission receipt, QA and data entry performed, QC performed, board assignment
Day 3-5 = board members pre-review
Day 6 = convened board meeting
Day 7-8 = post meeting processing, formatting Informed Consent, QC performed
Day 8 = distribution of approval documents to Investigator (copied to CRO, Sponsor)

 
Expedited review items = 5 calendar days
Day 1 = submission receipt, QA and data entry performed, QC performed
Day 2-3 = board member review (by one scientific IRB member)
Day 4-5 = post review processing, formatting Informed Consent, QC performed
Day 5 = distribution of approval documents to Investigator (copied to CRO, Sponsor)
Impressive Quality
 
IntegReview maintains a Corrective and Preventative Action (CAPA) program that tracks the quality of study documents and determines when/where to incorporate corrective action as to not repeat an error.  Our CAPA program encompasses errors found internally prior to leaving our office as well as those errors discovered by our clients.  
 
The trending results from Q1 through Q3, 2009 represent a 97.63% accuracy rate.
4th Annual Site Solutions Summit     beach
 
For the first time IntegReview had the honor of attending this year's 4th Annual Site Solutions Summit in Clearwater Beach, FL as a supporter (exhibitor).  The Summit is hosted by Rx Trials Institute and Association of Clinical Research Organizations (ACRO).  Even though the conference agenda is focused mostly on sites, we as an IRB felt very welcome, had lucrative discussions with Investigators as well as site staff and made some valuable contacts and long-life friends.  We are looking forward to attending next year!
 
In addition, we want to join everyone in congratulating GSK and Quintiles for winning this year's Eagle Award!  The award honors the recipients for their outstanding leadership, professionalism, integrity, passion and dedication to advancing the clinical research profession through strong site partnerships. Read more...
Upcoming Events 2010

February 27:  Annual IntegReview Training Seminar
March 2-5:  Joint Conference - 50th Cardiovascular Disease Epidemiology and Prevention - and - Nutrition, Physical Activity and Metabolism (Hosted by the American Heart Association) 
April 12-14:  Association for the Accreditation of Human Research Protection Programs (AAHRPP)
April 24-26:  Association of Clinical Research Professionals (ACRP)
June 13-17:  Drug Information Association (DIA)
October 15-17:  Site Solutions Summit (SSS)
You can count on IntegReview to provide the highest quality IRB services.  We welcome the opportunity to assist you with your future research projects and look forward to a continuing relationship.
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  IntegReview Ethical Review Board
  3001 S. Lamar Blvd., Suite 210
  Austin, TX  78704