Medical Device CRO Blog

Sharing of Clinical Trial Data – Considerations for Researchers to Show Their Work...

Posted by Emily Haglund on Fri, Feb 05, 2016

The sharing of clinical trial data has become an increasingly discussed topic in the scientific community and could soon create impacts beyond that of scientists that include the public and those that participate in clinical research. The concept focuses on the sharing of clinical trial data that led to conclusions presented in scientific publications. It is a way for researchers and scientists to “show their work” and support how conclusions were reached.

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Topics: Institute of Medicine, International Committe of Medical Journal Editors, Clinical Trial Data

Study Closure and Final Sponsor Report

Posted by Jaime Wynbrandt on Mon, Feb 01, 2016

We have all had sites that close prior to the study actually being completed. It is always asked if the site’s IRB allows them to close the study and submit the Sponsor’s final report when the study is completed or if the study needs to remain open at the site to allow the final report to be received by the IRB.

If the study needs to remain open with the IRB, this can become time consuming and costly if the study completion is several years away.  The site would need to submit for Continuing Review each year until the Sponsor’s final report is received.

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Topics: FDA, IRB, Sponsor Report, Study Closure

FDA Hits User-Fee ERA Record

Posted by John Lehmann on Fri, Jan 29, 2016

The number of original PMAs for completely high-risk devices and panel track supplements for major new updates approved by the FDA, was at its highest level since 2001.  Approvals increased to 56% in 2015 compared to the previous year and almost double the 2013 total.

So is this the new normal or just a one-year spike? 

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Topics: FDA, CDRH, William Maisel, User Fee, Paul LaViolette

21 CR 812.100: A Medical Auditor's Favorite Regulation

Posted by Mary Lewis on Wed, Jan 27, 2016

I am often asked by industry colleagues that if I had to pick just one “favorite” federal regulation what would it be?  The answer is easily 21 CFR 812.100, as this regulation embodies 95% of the investigational site non-compliances  I observe as I conduct clinical investigator audits. Let me elaborate.

21 CFR 812.100 falls under Subpart E- Responsibilities of Investigators of the IDE Regulations.  This regulation succinctly details investigator responsibilities in just two sentences.

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Topics: Investigator Responsibilities, Clinical Reearch, FDA, 21 CR 812.100

A Question of Disclosure: FDA Findings and Publications

Posted by John Lehmann on Fri, Jan 22, 2016

When the Food and Drug Administration (FDA) identifies significant findings with the conduct of a clinical trial during an inspection, what happens to those findings? According to a article published online by JAMA Internal Medicine, those findings remain hidden in plain sight.

Charles Seife, MS, a professor at the Arthur L. Carter Institute of Journalism at New York University, conducted a research study that sought to “identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature.”

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Topics: Charles Selfe, FDA Warning Letters, FDA Inspection

What to do When New information is Presented?

Posted by Michael Marotta on Fri, Jan 15, 2016

On the eve of the day we welcomed 2016 the FDA issued a draft guidance regarding notification of the public on “emerging signals” regarding medical devices that are already used in clinical practice.  The FDA defined an emerging signal as “new information about a medical device” that:

  1. The Agency is monitoring or analyzing
  2. Has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device
  3. Has not been fully validated or confirmed
  4. For which the Agency does not yet have specific recommendations
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Topics: Draft Guidance, FDA, Emerging Signals

Hear Ye, Hear Ye, This Meeting is Called to Order

Posted by Michael Marotta on Wed, Jan 13, 2016

This is the second of a two blog series on the Draft Guidance for Institutions and IRBs.  The first blog was published on January 7, 2016.

In November 2015, the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) jointly issued a draft guidance to assist both institutions and institutional review boards (IRBs) in preparing and maintaining minutes of IRB meetings. The requirement for an institution or IRB to prepare and maintain adequate documentation of IRB activities can be found in the regulations (45 CFR 46.115; 21 CFR 56.115) and inadequate meeting minutes has shown up as a common deficiency in 2014 IRB inspections and Warning Letters. As a result, the draft guidance was prepared to provide recommendations on the type and amount of information to include in the minutes.

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Topics: Draft Guidance, IRBs, FDA, Institutions

Minutes of Institutional Review Board (IRB) Meetings: Draft Guidance for Institutions and IRBs

Posted by Emily Haglund on Thu, Jan 07, 2016

The draft guidance “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs” was released jointly by the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in November 2015. This draft guidance document is intended to assist institutions and IRBs responsible for preparing and maintaining minutes of IRB meetings, describe requirements for minutes, and provide recommendations for meeting the regulatory requirements for minutes.

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Topics: Draft Guidance, IRBs, FDA, Office for Human Research Protections, Meetings

Significant Risk vs. Non-Significant Risk Determination

Posted by John Lehmann on Tue, Jan 05, 2016

Dr. Harvey Arbit of Arbit Consulting has penned a whitepaper for IMARC Research titled, “Significant Risk/Non-Significant Risk Determination and IDE Applicability.”  Although the Medical Device Amendments were enacted on May 28, 1976, it still seems that after all these years there is confusion and misunderstanding regarding the process for determining if an investigational device is Significant Risk (SR) or Non-Significant Risk (NSR).

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Topics: Dr. Harvey Arbit, Signficant Risk, Non-Signficant Risk, FDA

The History of Clinical Research eBook

Posted by John Lehmann on Tue, Dec 29, 2015

For clinical research professionals, the protection of human subjects has always been of paramount importance. Doing so while ensuring accurate and credible data are obtained are the primary roles for every individual on a research team. Unfortunately, history reminds us that unethical research practices and/or disregard for the well-being of human subjects has not only occurred in the past, but continues to do so today.

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Topics: Sandra Maddock, History of Clinical Research, IMARC Research