Quarterly IRB Newsletters
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Change in IRB Process for Informed Consent Documents - No Site Name and Site Address Required - Effective October 1, 2015 IntegReview will no longer require the study site names/addresses to be included in the informed consent document (ICD). There is no federal regulatory or AAHRPP requirement that requires the inclusion of study site names/addresses to be included in the ICD.
This IRB process change will streamline the processes involved with ICDs and will assist in our obligation to provide you with a more expedient turn-around of your documents. The ICD will continue to include the name of the Principle Investigator and the site contact number.
IntegReview IRB process effective October 1, 2015:
When site names/addresses are included in new ICFs they will be removed. Please refer to our Sample IC templates available on our website for information on IRB requirements. In addition, the informed consent(s) will be updated to remove site names/addresses upon any requested change to the informed consent or at the time of Continuing Review, as applicable.
IntegReview IRB Changes Address - IntegReview moved to a new location in July 2015. The new mailing address is: 3815 S. Capital of Texas Hwy, Suite 320, Austin, TX 78704.
"DRAFT" FDA Guidance - Use of Electronic Consent in Clinical Investigations - This draft guidance document, distributed in March 2015, provides recommendations for clinical investigators, sponsors, and IRBs on the use of electronic media and processes to obtain informed consent. FDA's requirements for electronic records/ signatures, informed consent, and IRBs are set forth in 21 CFR parts 11, 50, and 56, respectively. The information presented to the subject, processes used for obtaining informed consent, and documentation of the electronic informed consent (eIC) must meet the requirements of these and other applicable regulations. [READ MORE]
IntegReview Expands IRB Oversight of Clinical Research to Japan - Effective March 19, 2015, IntegReview extended its IRB oversight to sites located in Japan. This review applies to research that is governed by a U.S. federal agency and a local Consultant will be utilized to assist in the IRB review. Call us to learn more about this new service at 512-326-3001.
September 25, 2015: IntegReview IRB Receives Reaccreditation from AAHRPP
IntegReview IRB announces its reaccreditation by the Association for the Accreditation of Human Research Protection Programs, Inc.® (AAHRPP).
“IntegReview IRB is proud to receive reaccreditation from AAHRPP,” says Melissa Meyer, CCRP, Vice President. “Our company continues to strive to bring exemplary customer support to our clients while providing the highest standard of ethical review to research projects.” [READ MORE]
September 14, 2015: IntegReview IRB Announces Move to New Location
IntegReview IRB officially announced their move to a new location along Austin’s beautiful Barton Creek Greenbelt, located at 3815 S. Capital of Texas Hwy, Ste. 320, Austin, TX 78704. “We are thrilled to be in our brand new office,” says Melissa Meyer, Vice President for IntegReview IRB. “Our team designed a forward-thinking, environmentally-friendly layout to create a great working atmosphere for our employees. Our expansion will allow us to meet the increasing clinical research needs of our clients.” [READ MORE]
May 21, 2015: IntegReview IRB and Verified Clinical Trials have developed a preferred partnership to stop dual enrollment in clinical trials and reduce protocol deviations while promoting safety. [READ MORE]
2017 Upcoming Events
|April 28 - April 30||AERA Conference||San Antonio, TX||Exhibitor|
|April 29 - May 2||ACRP Conference||Seattle, WA||Exhibitor|
|May 22 - 24||MAGI West Conference||Philadelphia, PA||Panel Speaker|
|June 18-22||DIA Conference||Chicago, IL||Exhibitor|
|Oct 6 - 8||Site Solutions Summit||Boca Raton, FL||Exhibitor|
|Nov 6 - 8||PRIM&R Conference||San Antonio, TX||Training|