Meet the IRB Staff
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Betty Maldonado,
Regulatory Compliance Manager |
Betty's primary function is to provide supervision, guidance and oversight of the day-to-day quality assurance and quality control activities in an effort to enhance and maintain the quality of services provided to clients. She is married with a 20 month old growing baby and a 12 year old beautiful stepdaughter. In her spare time she enjoys spending time with family & friends, being outdoors and is currently in training to facilitate "life balance" retreats for the Center for Well Being.
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Angelica Martinez, IRB Coordinator, Co-chair |
Angelica's main responsibility is serving as a Co-chair for the IRB. Her focus is on the activities associated with the IRB meetings and of the day-to-day administrative activities to ensure the protection of human subjects involved in research. She enjoys the different cultures, foods and endless entertainment Austin has to offer. Angelica is a wife, a mother and most recently a proud grandmother.
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IntegReview Interoffice Announcements
May 4 - Christine Skruhak, IRB Administrative Associate II (5)
May 9 - Tonya Reed, Assistant Coordinator (9)
May 16 - Erik Guerra, IRB Administrative Associate II (6)
June 1 - Jami Brackeen, IRB Coordinator, Co-chair (5)
July 4 - Valerie Nelson, IRB/REB Coordinator, Co-chair (7)
July 10 - Lynn Goldman, Operations Manager (7)
10+ YEAR ANNIVERSARIES
May 7 - Pricilla Gage, Senior QA Associate (13)
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Community
Involvement
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IntegReview IRB is proud to support community organizations either through donations, corporate sponsorship, fundraising efforts and/or raising awareness by "walking/running for the cause".
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It is our commitment to provide exemplary protection to subjects while overseeing your research project. Customers who entrust their business to us share a common desire to protect research subjects. We pledge to do everything possible to earn the respect and trust of our customers while delivering a service that exceeds customer expectations.
Your interest and satisfaction is important to us. If there is information/content you would like to see in upcoming issues please let us know by emailing [email protected]. |
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New Final Guidance - FDA Decisions for Investigational Device Exemption Clinical Investigations
 Issued on August 19, 2014, this final guidance document was developed to facilitate the initiation of clinical investigations to evaluate medical devices under FDA's Investigational Device Exemptions (IDE) regulations, Title 21 Code of Federal Regulations (CFR) Part 812.
This guidance is intended to provide clarification regarding the regulatory implications of the decisions that FDA may render based on review of an IDE as well as a general explanation of the reasons for those decisions.
In an effort to promote timely initiation of subject enrollment in clinical investigations in a manner that protects study subjects, FDA has developed methods to allow a clinical investigation of a device to begin under certain circumstances, even when outstanding issues remain regarding the IDE submission. These mechanisms, including Approval with Conditions, Staged Approval, and communication of outstanding issues related to the IDE through Study Design Considerations and Future Considerations, are described in this guidance.
To learn more click here for the full guidance document. |
"Draft" Guidance - Informed Consent Information Sheet 07/2014
This DRAFT guidance is currently accepting comments and suggestions prior to publication.
This guidance is intended to provide information to IRBs, clinical investigators, and study sponsors about FDA's informed consent regulations. This guidance, when finalized, will supersede "A Guide to Informed Consent," issued in September 1998, by the Office of Health Affairs, FDA. To learn more click here for the full guidance document. |
Tip #1 - Copy a form! When you see the  icon next to a previously submitted New Study Submission Form, simply click on the icon and you will create a copy of that form showing your previous answers. Note: Not all answers will copy, this is purposeful and designed by the IRB.
Tip #2 - Find your approval documents in a sub-folder located in the 'Att' column and also within the Event in 'Attachments'.
Tip #3 - "Jump" pages on the xForms to allow you to navigate to any page without yet completing the entire page (i.e. temporarily skip required questions).
Tip #4 - Identify & add multiple contacts to a study on the New Study Submission Forms. Additionally, identify which contacts wish to receive all or none of the automatic e-mail notifications.
Tip #5 - Keep your profile up to date by ensuring your mailing address, phone number, etc. is current in your Settings Tab.
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What Our Customers Are Saying...
 "I can contact a live person at anytime and I receive return calls - quick responses to any question."
"I appreciate how accessible IntegReview is to us when questions or situations come up that need clarification. I've requested guidance before and have always received a quick response - really positive experiences."
"IntegReview has been excellent to work with. I am new to IntegReview and the IRBManager system, but everyone I have encountered has been very friendly and helped me navigate."
"Knowledgeable, courteous and helpful staff who offer good insight and support and can always be trusted to provide timely and accurate responses to questions."
"Accessibility to all required forms, ease of communication, rapid response times, transparent and easy to understand processes." |
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2014 Networking & Training Opportunities
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Rick Clemens
Vice President of
Business Development |
Sarah Attwood
Associate Director of
Business Development |
If you are interested in arranging a meeting with our Business Development Group during these events, please send an e-mail to [email protected].
September 19-21: SoCRA; Orlando, FL (Exhibitor)
September 27-October 1: RAPS; Austin, TX (Exhibitor)
October 10-12: Site Solutions Summit; Amelia Island, FL (Exhibitor) - IntegReview IRB President, Lynn Meyer, CCRP, will be a member on a panel.
What to expect this year at ACPU:
- Tour of DaVita Clinical Research Facilities
- Breakout Sessions for Investigators, Sponsors, Operations, Regulatory, Recruitment, Pharmacy, Nursing and Business Development
- Panel Discussion on the trends in partnerships and collaboration in Early Phase Clinical Research
- IntegReview IRB President, Lynn Meyer, CCRP, will be a Speaker and a panel member of the IRB breakout session
December 5-7: PRIM&R; Baltimore, MD
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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. |
IntegReview IRB
3001 S. Lamar Blvd., Suite 210
Austin, Texas 78704
512.326.3001 512.697.0085 (fax)
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