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Unapproved Devices on

Unapproved Devices on

Currently, trial results for are only required to be submitted to the online database for cleared or approved devices.  However, a November 19th proposal from the National Institutes of Health which would require trial results and descriptive information for devices and device indications that have yet to be cleared or approved by FDA would be posted on the public website.  The proposal would give trial sponsors up to three years between the completion of the trial and when results nee to be submitted to NIH if they are legitimately working towards reaching the market.

How Important is a Clinical Research Coordinator?

How Important is a Clinical Research Coordinator

Often, when one thinks of the team that actually brings a new medical device or drug to market, the first people that come to mind are those at the sponsor company and the investigators at the individual sites – the leaders of the study.  What may be less known, though, is that often the study hinges on the shoulders of the Clinical Research Coordinator (CRC).  Briefly, CRCs are responsible for the accurate maintenance of the records for the trial, as well as many parts of the trial that otherwise may be overlooked.  Some of the major responsibilities of the CRC are:

I’m Looking Through You… More Transparency for Clinical Trials?

More Transparency for Clinical Trials

Recently, the United States Department of Health and Human Services and the National Institute of Health (NIH) issued two proposed rulings that may have a profound impact on how results of clinical trials are made more transparent to the public.  However, before we discuss these proposals, we should discuss briefly how the public has access to clinical trials.

Will Voluntary Audits Help the FDA?

Voluntary Audits Help

In the clinical research industry approvals for investigational products are not granted- they are earned. With FDA and International inspections on the rise, so are stress levels of everyone involved in clinical studies. Auditing can be looked at as a quality improvement process, and a way to prepare for inspections and approval by:

FDA Reforms Looming?

FDA Reforms Looming

An article in “The Gray Sheet” recently caught my attention.  It talked about how the recent takeover by the Republican Party in the Senate, along with an increase in GOP House seats, could lead to an increased oversight of the FDA.

Do You Know the Difference Between a Consent for Research and a Standard Consent for Treatment?

Do You Know the Difference Between a Consent for Research and a Standard Consent for Treatment

Coming from a background of working as a patient care nurse in the ICU, I would witness the consent process on a daily basis for biopsies, bronchoscopies, chest tubes, arterial lines, etc... These were non-research procedures; they were procedures to assist in the treatment of the critically ill. When I first started a career in research, I already knew that obtaining consent was more than a piece of paper and that it was a discussion and a process, but “a consent is a consent” for standard treatment in a hospital or for research, right? WRONG- I found out very quickly through IMARC’s training program that obtaining consent in research involves so many different specific elements, different from an informed consent for non-research procedures.

Risk Management in Clinical Research

Risk Management in Clinical Research

As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a new whitepaper that discusses the principles of risk management and their application to clinical research.

Sponsor-Investigators: Force the Formality

Sponsor Investigators   Force the Formality

Sponsor-Investigators are uniquely dedicated and invested in clinical research. In a previous blog post, IMARC described how Sponsor-Investigators have to wear two hats and follow two sets of regulations.

Protocol Development - Is this Medical Test Really Necessary?

Protocol Development     Is this medical test really necessary

Regardless if you are reading this from a sponsor, site, monitor or IRB perspective, we have all worked on a protocol with a medical test that really seems unnecessary or obsolete, not to mention, difficult to obtain with in the time window specified by the protocol.

Cybersecurity in Medical Devices: New FDA Guidance

Cybersecurity in Medical Devices   New FDA Guidance

On October 2, 2014 the FDA issued a guidance that reflects current thinking on management of cybersecurity in medical devices. Device manufacturers are encouraged to consider potential threats of hackers and security breaches in the research, design, and development of medical devices. The FDA further recommends incorporating device protection plans into premarket submissions. This has the potential to increase costs in all phases of production.

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