Quorum Blog

04/17/2012

Quorum Review is on the Map Toward a Greener Seattle

  Quorum Review is proud to be “on the map” as a Greener Seattle Business. Quorum has  made changes toward being more environmentally conscious and has established “going green actions.” These actions include expanding recycling programs, reducing paper, purchasing recycling content supplies and educating employees about even greater green business practices. Quorum Review is also [...]

04/12/2012

Slides Now Available: Quorum Review Webinar – Research and HIPAA: Recruitment, Consent, and Beyond

A “nuts and bolts” training regarding the implications and requirements of HIPAA in the context of recruitment, the consent process, the duration of the study and even after study closure. This presentation will provide an overview of HIPAA privacy rules and guidelines.  Covered topics will include the responsibilities of the researchers, sponsors, and IRBs. Presented [...]

04/03/2012

Health Canada’s January Draft Guidance: Women in Clinical Trials and Data Analysis by Sex

On January 9, 2012, Health Canada released its Draft Guidance entitled, Considerations for Inclusion of Women in Clinical Trials and Analysis of Data by Sex.  If finalized, this Guidance supersedes the 1997 Health Canada Guidance entitled, Inclusion of Women in Clinical Trials.    The Draft Guidance is intended to support and encourage good therapeutic product [...]

03/12/2012

MAGI Clinical Research Conference: Early-Bird Discount

Quorum Review IRB is registered to attend this year’s MAGI Clinical Research Conference in Washington DC, May 20-23. Make sure to stop by our booth and learn why Quorum Review is the IRB of choice when performance matters.  With over 600 attendees, MAGI is quickly becoming one of the fastest growing conferences in clinical research.  [...]

03/06/2012

Final Guidance Summary: Guidance for IRBs, Clinical Investigators and Sponsors – IRB Continuing Review After Clinical Investigation Approval

On February 27, 2012, the FDA announced the release of the final guidance entitled, Guidance for IRBs, Clinical Investigators and Sponsors: IRB Continuing Review After Clinical Investigation Approval. This guidance document finalizes the draft guidance initially published in January 2010, and supersedes the Information Sheet, Continuing Review After Study Approval (September 1998, Office of Health [...]

02/16/2012

FDA Releases Guidance: New Informed Consent Requirement

In February 2012, the FDA released a Guidance document to assist IRBs, Investigators, and Sponsors with understanding and implementing the informed consent requirement found at 21 CFR 50.25(c), which states the following language must be included in consent documents for applicable studies initiated on or after March 7, 2012: “A description of this clinical trial [...]

12/08/2011

Recording and Slides Now Available from Quorum’s Webinar – Using Electronic Consent and Technologies to Facilitate and Improve the Research Process

Implementing electronic technologies may facilitate research, improve research efficiency, and benefit research participants. However, successfully implementing these technologies requires understanding the applicable regulatory requirements and IRB considerations. This Webinar will address electronic technologies for obtaining consent, facilitating consent, storing study data, and monitoring study data. For each of these four topics, the presenter will discuss [...]

12/06/2011

Recording and Slides Now Available from Quorum’s Webinar – Using Social Media in Research: Regulatory and IRB Considerations!

Social media in all of its forms presents exciting possibilities for researchers. However, navigating the current regulations can present problems for researchers and IRBs. This webinar covers the use of social media in three aspects of research: recruitment, communication during the course of a study, and post-study communications. Quorum’s regulatory experts discuss the current regulatory [...]

08/23/2011

Quickly and easily complete your initial site submission with Quorum’s new Smart Forms!

Quorum is always looking for ways to improve our services for you. Our latest innovation, Smart Forms provide you with a faster, easier, and more accurate way to complete your initial site submission. Smart Forms contain built-in logic that helps streamline the submission process, saving you time and reducing errors.  Located in the Secure Submissions [...]

05/05/2011

Attend Quorum’s Exclusive Webinar on June 2 – Using Social Media in Research: Regulatory and IRB Considerations!

Social media in all of its forms presents exciting possibilities for researchers. However, navigating the current regulations can present problems for researchers and IRBs. Quorum Review IRB invites you to attend our exclusive webinar that specifically addresses this topic. Using Social Media in Research: Regulatory and IRB ConsiderationsThursday, June 2, 2011 at 10:00 AM PT [...]