WIRB Education and Consulting

ECS
Overview
Education &
Training
Consulting
Services
Accreditation
Support
WIRB Credentialed
Investigators

Bring WIRB's experience to your team

Improve your ability to maintain compliance and protect human subjects with guidance from our experienced educators and consultants. We offer a wide array of training, consulting, and staffing services for investigators and sponsors addressing IRB, IBC, and data or safety monitoring topics.

Education & Training

Following is a list of our live courses held at various locations around the United States, online WIRBinars, eLearning courses, and recordings of previous WIRBinars. For more information on these services or to subscribe to our education updates and special discounts, click on the more information tab below.

Live Trainings 2012

WIRB offers a variety of live seminars and workshops on issues important to research professionals. Select the register link for additional details and registration options.

Date	Seminar Title	Price
May 17	Investigator Training for Medical Research Dallas, TX	$594	Register
May 18	Site Operations and SOPs Dallas, TX	$494	Register
May 17 - 18	2 Day Training Package: Day 1 - Investigator Training, Day 2 - Site Operations and SOPs (Save $194 over 2 days!) Dallas, TX	$894	Register

Fees. Course fees include participant notebook, supplemental materials, access to speaker after program for questions, and certificate of completion. All participants are responsible for their own meals and travel.

Payment. We accept Visa, MasterCard, and AMEX. We are unable to invoice for training.

Credits. The Society of Clinical Research Associates (SoCRA - www.SoCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.

Recordings. Live courses will not be recorded.

Discounts. When 3 enroll from your organization, the 4th person attends for FREE. Please contact edu@wirb.com to register your 4th attendee.

Cancellation Policy. If you cannot attend, you may send a substitute or receive a credit memo toward a future course. If you cancel your registration up to seven business days before the course, your registration fee will be refunded.

Certificates. Certificates of Attendance will be awarded at the completion of each course.

Online WIRBinars 2012

WIRB offers a variety of webinars on issues important to research professionals. Join a live session or purchase a recorded version to watch any time. Each registration gives you one connection for as many attendees that can fit around the one phone line! Select the register link for additional details and registration options.

New in 2012! A WIRBinar series titled "Research Dilemmas" - Join us for a variety of exciting topics every other Wednesday in 2012!

Date	Seminar Title	Price
February 15	Investigator Initiated Trials – What Are Your Investigator/Sponsor Responsibilities? WebEx Online	$249	Register
February 29	Does My Project Need IRB Review? WebEx Online	$249	Register
March 14	When Do I Need An Authorization To Use PHI For Research? WebEx Online	$249	Register
March 28	What SOPs Should I Have And How Do I Create Them? WebEx Online	$249	Register
April 11	What Do I Report And When Do I Report It? WebEx Online	$249	Register

Fees. Each registration is good for one connection to the live visual presentation and audio. Unlimited number of attendees in the same room may attend. Each fee includes subject matter expertise, participant handout, access to the Q&A session, and a certificate of completion for the registered attendee.

Payment. We accept Visa, MasterCard, and AMEX. We are unable to invoice for training.

Credits. The Society of Clinical Research Associates (SoCRA - www.SoCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1.0 hours of CE credit.

Recordings. Each WIRBinar will be recorded and available for purchase within 7 business days of the live training. Certificates of attendance and question and answer sessions will not be included on the recorded session.

Discounts. If you would like to register 3 or more connections, please contact edu@wirb.com for a discount code.

Cancellation Policy. You may cancel your attendance for full refund up to 3 hours prior to the live training event. Cancellations must be made through the cancelation link on your confirmation email for full refund.

Certificates. Certificates of Attendance are awarded to the registered attendee for each live WIRBinar.

eLearning and Recorded Courses

Format	Seminar Title	Price
Recording	Enrolling Adults with Limited Capacity to Consent WebEx Online	$249	Register
Recording	Importance of an effective corrective and preventive action program Tanna May MacReynold, CIP	$249	Register
Recording	New Advance Notice of Proposed Rulemaking David Forster, MA, JD, CIP	$249	Register
Recording	How to survive an FDA inspection of your clinical trial site Troy Brinkman, MA, JD	$249	Register
Recording	Organizing, Executing and Analyzing a Successful and Compliant Subject Recruitment Campaign Tammy N. Anderson, CCRC, CCRA, CRCP	$249	Register
e-Learning	Research and the HIPAA Privacy Rule Try it free for a limited time!	FREE	Register
e-Learning	Protecting People in Clinical Research Try it free for a limited time!	FREE	Register

Fees. Each registration gives access to view the course for 15 days from date of purchase. E-learning courses are designed to be used by one individual, while recordings may be viewed by unlimited persons in the same room.

Payment. We accept Visa, MasterCard, and AMEX. We are unable to invoice for training.

Credits. The Society of Clinical Research Associates (SoCRA - www.SoCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1.0 hours of CE credit.

Recordings. WIRBinars will be recorded and available for purchase within 7 business days of the live training.

Discounts. If you would like to register 3 or more courses, please contact edu@wirb.com for a discount code.

Cancellation Policy. No cancellations are accepted for elearning and recorded courses.

Certificates. Please contact edu@wirb.com to request a certificate.

Onsite Training

Good Clinical Practice. We provide onsite training on good clinical practice (GCP), and we offer this training periodically at locations across the U.S.

IBC Training. To help meet NIH training guidelines on rDNA research, IBC Services can provide customized training with examples drawn from our in-depth experience. IBCS can also present IBC-related topics to local, regional, or national meetings. Sample topics include:

Overview of human gene transfer
Biosafety in the medical clinic
Introduction to the NIH guidelines
Preparing for your first human gene transfer study

Customized Training. Whether it is initial training for new members or ongoing training for experienced staff and board members, we can provide services that are tailored to meet your IRB's needs. Training can be provided with an onsite instructor or on the web.

More Information

For more information on WIRB's training offerings, contact us.

To receive email updates on upcoming training opportunities and discounts, join our email list.

Consulting Services

Protocol review and development

Catch problems before submission—let us help write your protocol or review your existing protocol to see if there are any regulatory or ethical issues that might prevent or delay IRB approval.

Consent form review and writing

WIRB's experts can write your consent form or review your existing consent form to be sure it is understandable and in compliance with regulations and applicable law.

Onsite compliance assessment for researchers

Have an expert visit your site for a consultation on best practices and assessment of compliance with regulations and other applicable law, including a review of SOPs, delegation procedures, recruitment, and consent process. If issues are identified we can help you develop and implement a corrective action plan.

Consultation services for IRBs

WIRB has experienced IRB professionals with a wealth of knowledge to provide assistance to IRBs who are facing challenges and require expertise. We have Certified IRB Professionals who can offer sound and valuable solutions to the issues that face your IRB.

Onsite compliance assessment for IRBs

WIRB's experts will evaluate your operations and provide a report and suggest best practices. We will talk with your staff and board members and review written policies and procedures, IRB minutes, and selected study files to see if the documentation is adequate and to see if your reviews are consistent with regulations, guidance, and SOPs. Following our assessment, we will conduct a gap analysis and provide information on practices.

Support for IRB review

WIRB can provide interim or permanent regulatory support for IRB review. We can advise your IRB before, during, and after the review to ensure that the required determinations are made and documented, and that the review is in compliance with regulations, guidance, and local law.

Data and safety monitoring consultations

We can provide protocol development consultation to focus your data monitoring plan and help present it to regulators.

Getting started

For more information on WIRB's consultation offerings, contact us.

We can help you navigate the accreditation process from start to finish, including self-assessment, development of documentation that satisfies AAHRPP's Standards and Elements, the application process, and response to AAHRPP reports.

Investigator credentialing

Credentialing has significant benefits for investigators and research staff, including a significant reduction in the time and energy it takes to complete submission. Every time an investigator becomes credentialed, the Board can have confidence that the investigator has the right processes in place and sufficient knowledge to protect subjects enrolling in research at his or her site. Credentialed investigators who so choose may be included on a list of credentialed investigators that will be provided to sponsors and CROs.

Requirements

Credentialing involves an onsite visit by a WIRB professional who provides training, gathers information about the investigator and research staff, and reviews standard operating procedures. During this time, investigators will be given direct input on how to best comply with regulations and ethical standards. Once the credentialing visit is completed, a report will go to the Board for review and the Board will decide whether to award credentialed status to the investigator. WIRB will maintain a database of credentialed investigators and will make periodic contact to see if there have been any changes.

Costs

There is no fee for this service. We believe that offering this service will promote subject safety and result in faster turnaround time for review of submissions.

Getting started

To learn more about WIRB's accreditation services, contact us.

The investigators below have received WIRB’s training on good clinical practice, human subject protections and WIRB’s reporting requirements. This training also includes extensive discussion on the FDA’s guidance on investigator responsibilities. In addition to the training, WIRB has assessed the investigator’s practices for consent and supervision of research and found it satisfactory at the time of the assessment. For more information on WIRB's credentialing program, contact WIRB’s Investigator Services Coordinators at sitevisits@wirb.com.

Credentialed Investigators

Name: Barry F, Blitz, M.D.
Specialty: Urology
Address: 7451 Gladiolus Drive, Fort Myers, FL 33908
Phone Number: 239-689-8800
Email Address: bfblitz@gmaiLcom

Name: Eric B. Carlson, M.D.
Specialty: Cardiovascular Diseases
Address: Eastern Cardiology, PA 2090-B West Arlington Boulevard, Greenville, NC 27834
Phone Number: 252-757-3333
Email Address: ericbcarlson@easterncardiology.com

Name: Franco Felizarta, M.D.
Specialty: Internal Medicine and Infectious Disease
Address: 3535 San Dimas Street, Suite 24, Bakersfield, CA 93301
Phone Number: 661-324-3128

Name: Jonathan I, Macy, M.D.
Address: 8635 West Third Street, Suite 360W, Los Angeles, CA 90048
Specialty: Ophthalmology
Phone Number: 310-657-2777
Email Address: jimacy@macyeyecenter.com

Name: Mary Petruso, M.D. (ASCP)
Specialty: General Laboratory Administration
Address: 2030 West McNab Road, Fort Lauderdale, FL 33309
Phone Number: 954-633-3541
Email Address: mpetruso@nationwidelab.com

Name: W. Alvin McElveen, M.D.
Specialty: Neurology
Address: Bradenton Research Center, 3924 9th Ave. W., Bradenton, FL 34205
Phone Number: 941-708-0005
Email Address: bradentonresearchcenter@verizon.net

Name: Richard J. Melker, M.D., Ph.D.
Specialty: Pediatrics, Emergency Medicine
Address: Department of Anesthesiology, PO Box 100254, Gainesville, FL 32610-0254
Phone Number: 352-494-7420
Email Address: rmelker@anest.ufl.edu

Name: Eli O. Meltzer, M.D.
Specialty: Allergy, Asthma, Immunology
Address: Allergy &Asthma Medical Group and Research Center, A P.C.
5776 Ruffin Road, San Diego, CA 92123
Phone Number: 858-268-2368
Email Address:aamgrc@allergyandasthma.com

Name: Michael J. Welch, M.D., CPI
Specialty: Allergy, Asthma, Immunology
Address: Allergy & Asthma Medical Group and Research Center, A P.C.
5776 Ruffin Road, San Diego, CA 92123
Phone Number: 858-268-2368
Email Address: aamgrc@allergyandasthma.com

Name: Nancy K. Ostrom, M.D., CPI
Specialty: Allergy, Asthma, Immunology
Address: Allergy & Asthma Medical Group and Research Center, A P.C.
5776 Ruffin Road, San Diego, CA 92123
Phone Number: 858-268-2368
Email Address:aamgrc@allergyandasthma.com

Name: Timothy E. Morey, M.D.
Specialty: Anesthesiology
Address: Department of Anesthesiology, MSB M-509, P.O. Box 100254, 1600 Southwest Archer Road, Gainesville, FL 32610 Phone Number: 352-392-6891
Email Address: tmorey@anest.ufl.edu

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