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What is IntegReview?
Has IntegReview been audited by the FDA?
How often does the Board meet?
How do I get copies of your current forms?
When will my study be reviewed?
What is the submission deadline for a new study?
What is the submission deadline for an additional Principal Investigator to a previously approved study?
How do I submit a new study or additional Principal Investigator to a previously approved study?
What is the review and approval process after I submit my study?
What is the turnaround time for new studies and additional Principal Investigators to a previously approved study?
How will I receive my study documents?
How do I submit a request for changes to previously approved study documents?
What is the charge to review a study, additional Principal Investigator, protocol amendment, etc.?
How do I submit a request for a private conference on the Internet Web Board?
When do I notify IntegReview when a study has been completed?
When do I notify IntegReview when the PI or research personnel deviate from or violate the protocol?
What is the difference between a protocol violation and a protocol deviation and when should they be reported to IntegReview?
Is IntegReview registered with the FDA and/or OHRP?
What is IntegReview?
Established in January 1999, IntegReview Ethical Review Board is an independent IRB located in Austin, Texas. IntegReview staff and Board members exceeds 100 years of IRB and research experience. The composition of the Board and/or consultants represents a variety of expertise including:
| cardiology |
infectious disease |
oncology |
| dermatology |
rheumatology |
ophthalmology |
| endocrinology |
muskuloskeletal |
oral surgery |
| toxicology |
pulmonary |
psychology |
| hematology |
nutrition |
pharmacology/neuropharmacology |
| neurology |
radiolabeled compounds |
central nervous system |
| allergy/asthma |
immunology |
inflammatory/autoimmune |
| antimicrobial |
pediatrics |
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Has IntegReview been audited by the FDA?
FDA inspections performed at IntegReview include:
- January 26-29, 2004
- July 27-31, 2009
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How often does the Board meet?
IntegReview has four Boards that meet weekly.
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How do I get copies of your current forms? back to top
All of our forms can be downloaded from the Forms page of our Website.
When will my study be reviewed?
Your study will be reviewed at a Tuesday evening meeting. If Tuesdays are not feasible you can request an unscheduled meeting. Please see our submission deadlines page for more information.
IMPORTANT: Only complete submissions will be reviewed, please be sure that all questions are answered and all required attachments are submitted.
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What is the submission deadline for a new study?
The submission deadline for a new study is 12:00 PM Central Time on Wednesday prior to the following week’s meeting.
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What is the submission deadline for an additional Principal Investigator to a previously approved study?
There are no submission deadlines for submissions of additional investigators being added to a currently approved study or additional investigators scheduled for continuing review.
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How do I submit a new study or additional Principal Investigator to a previously approved study?
In order to adequately review the conditions surrounding the research, a New Study Submission form is required, which is available on the FORMS page of our Website. We do not require hard copies, therefore we prefer that all submissions be e-mailed to our Senior Quality Assurance Associate, Kellie Smith, at
, or they may be sent by another delivery method. Documents sent by U.S. Postal Service or other delivery service should not be stapled.
What is the review and approval process after I submit my study?
Your study will be assigned to one of the four Boards for review at the next convened meeting. Following Board review the study and study documents will be processed and distributed within 48 hours of the meeting. A complete process flowchart for new studies, as well as additional Principal Investigators is available on the PROCESSES page of our Website.
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What is the turnaround time for new studies and additional Principal Investigators to a previously approved study?
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IntegReview's proven track record of turning around documents within 48 hours of Board review is uniquely efficient. In most cases, study documents are distributed within 24 hours of Board review.
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How will I receive my study documents?
IntegReview attempts to use the Internet as much as possible when distributing study documents, as it is quick and convenient. If you have access to the Internet, and your or the Sponsor’s SOP’s permit, we will either e-mail study documents to you or set up a private password-protected conference on our Internet Web Board where study documents can be posted for you to download and print. You will indicate your preferred distribution method on the New Study Submission form.
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How do I submit a request for a private conference on the Internet Web Board?
To request a private conference on our Internet Web Board, download the Request for Web Board Conference form. Once you have completed the form, you may fax it to 512-326-3446 or e-mail the form to Victoria Govea, Team Manager at
Once we set up your private conference we will send you instructions via e-mail on how to access/use the site.
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How do I submit a request for changes to previously approved study documents?
In an effort to simplify the process as well as conserve your time, IntegReview has developed several forms for each type of submission. These forms are available on the FORMS page of our Website
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What is the charge to review a study, additional Principal Investigator, protocol amendment, etc.?
Our fee schedule is available on the SERVICES & FEES page of our website.
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When do I notify IntegReview when a study has been completed?
One of the procedural requirements found in Title 21 CFR 56.108(a)(3) requires ensuring "prompt reporting to the IRB of changes in a research activity." Therefore, upon completion of the study IntegReview requires notification. Please utilize IntegReview's Closure Notification form available on the FORMS page of our Website.
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When do I notify IntegReview when the PI or research personnel deviate from or violate the protocol?
As indicated in IntegReview's approval letter, significant protocol deviations are to be reported within 10 days of discovery. IntegReview does not consider protocol deviations to be different from protocol violations. Significant protocol deviations are those that deviate from the approved protocol and affect or can potentially affect the safety of subjects. Please utilize IntegReview's Significant Protocol Deviation Report form available on the FORMS page of our Website.
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Is IntegReview registered with the FDA and/or OHRP?
IntegReview is in compliance with current IRB registration requirements as it is registered with the Office of Human Research Protections (OHRP). Registration numbers assigned by OHRP to IntegReview's four (4) boards are IRB00001035, IRB00003657, IRB00004920 and IRB00006075, respectively. These registered boards are all under IntegReview's IRB Organization (IORG) number IORG0000689. More information is available on the FDA/OHRP IRB Registration page
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