Medical Device CRO Blog

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

Posted by Danielle Sas on Fri, Jun 26, 2015

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.

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Topics: Informed Consent, FDA, Clinical Research, Standard Consent

Direct Access to Electronic Medical Records for Data Verification

Posted by Mary Lewis on Tue, Jun 23, 2015

I had an interesting question come up today from a research manager whose site has recently switched to an EPIC EMR system.  She asked if copies of data that she had printed out of EPIC for source document verification for an upcoming visit would be adequate for purposes of source document verification. 

We all know that source documents are the gold standard for data verification.  Monitors and auditors ideally should be granted direct access to this information in order to verify study data; however with the plethora of concern surrounding private health information and individual privacy it seems to be getting more difficult to access this information easily.

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Topics: Electronic Source Documentation, EMR, SDV, Direct Access

Medical Device Regulations

Posted by Natalie Jarmusik on Fri, Jun 19, 2015

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar year.

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Topics: History of Clinical Research Timeline, FDA, Medical Device Industry, President Gerold Ford

Essential Document Review, What are you Looking For?

Posted by Stephani Hulec on Wed, Jun 17, 2015

As monitors we spend a significant amount of time reviewing the essential documents at the site during a monitoring visit.  The essential documents are usually housed in a Regulatory Binder or sometimes they are referred to as an Investigator Binder.

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Topics: Monitor, Regulatory Binder, Essential Documents, Sites

New House Bill Could Reduce 510(k) Submissions

Posted by John Lehmann on Fri, Jun 12, 2015

On May 21st the House Energy and Commerce committee unanimously passed a bill that would allow medical device companies to bypass 510(k) submissions for certain product modifications.  The 21st Century Cures bill will now move to the House floor, and bill sponsors hope for a vote by the end of the year.

The device “third-party quality system assessment section” was revised by the committee and would let companies make a device modification that would typically require a 30-day notice of a “special” PMS supplement could without a submission by having their quality system specially certified by a third-party auditor.

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Topics: FDA, 510(k), House of Representatives, 21st Century Cures Bill

Can Informed Consent be Obtained Electronically?

Posted by Paul Cobb on Tue, Jun 09, 2015

In March, 2015, FDA released a new draft guidance: Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.

FDA defines electronic informed consent (eIC) as using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent.

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Topics: Informed Consent, FDA, Electronic

Risk Management Whitepaper

Posted by John Lehmann on Fri, Jun 05, 2015

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

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Topics: FDA Guidance, Risk Management, IMARC Research Whitepaper

Expedited Review: Fast Track

Posted by Ryan Begun on Tue, Jun 02, 2015

In the wake of the recent Ebola pandemic, we realize the importance of pushing drugs and pharmaceuticals through the FDA approval process as quickly as possible. From drug discovery to FDA approval, the average drug takes roughly ten years costing $2.6 billion dollars during the process. Delaying the drug from reaching market just one day can cost the sponsor millions and potentially the lives of patients hindered by the condition the drug is to treat. With the pressing need for cures and treatments, an expedited approval has the potential to be advantageous for all. Over a series of blogs, I will review the four FDA expedited review programs.

The Fast Track approach to FDA expedited review is intended for drugs aimed to treat serious or life-threatening conditions and fill an unmet medical need. According to Section 506(b) of the FD&C Act, a product is eligible to be labeled as a fast track product “…if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.”

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Topics: FD&C Act, FDA, Fast Track

Do Form FDA 483s Matter Anymore?

Posted by Sandra Maddock on Thu, May 28, 2015

For clinical researchers, our “grade card” comes when the FDA inspects us.  We all want to be told that we’ve operated in a compliant manner and that there were no findings.  The alternative is to receive a Form FDA 483 (483) for significant deviations at the close of the inspection.  When I got my first 483 as a research coordinator 18 years ago, I remember thinking to myself “I’m not going to let that happen again.”  In my opinion, it was an indication that we had not delivered A+ work.  Since the stakes are so high in this environment, and we’re asking patients to trust us to perform, it was a big wake up call for me. 

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Topics: IMARC Research, FDA, Form 483s

Your Blog Will Voluntary Audits Help the FDA?

Posted by John Lehmann on Tue, May 26, 2015

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:

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Topics: Medical Device, FDA, Auditing