Medical Device CRO Blog

5 Steps to Make Your Monitoring Efforts Matter

Posted by John Lehmann on Wed, Jul 29, 2015

Monitoring remains our main focus at IMARC Research.  As discussed in a previous whitepaper, “Monitoring as a Mindset”, monitoring is defined by the FDA as the act of overseeing an investigation.  Specifically noted in 21 CFR 812.43, sponsors are required to select monitors qualified by training and experience.  In addition, 812.46 states that monitoring investigations should include securing compliance at investigative sites, whenever necessary.

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Topics: 21 CFR, IMARC Whitepaper, FDA, Monitoring

FDA Regulations - Title 21: 1981

Posted by Shawn Kennedy on Wed, Jul 22, 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 years.

In today’s day and age, it is a widely accepted and understood requirement that conducting clinical research for investigational new drugs and devices in the United States means that you will be responsible for following the FDA regulations.  The terms, “according to the regulations, “or “according to the regs,” are used commonly, as we all have grown accustomed to these seemingly intuitive laws that govern the practice of clinical research.  However, not too long ago, the regulations we freely refer to now did not exist.  It wasn’t until after the 1979 Belmont Report, that FDA and the Department of Health and Human Services formally revised regulations for human subject protections by creating Title 21 - Food and Drugs

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Topics: History of Clinical Research Timeline, FDA Regulations, Code of Federal Regulations (CFR) Title 21

Ensuring Proper Training for Clinical Research Staff

Posted by John Lehmann on Mon, Jul 20, 2015

Please take time to view Sandra Maddock’s  article “ Ensuring Proper Training for Clinical Research Staff in Less Time” that was recently posted on GxP Lifeline.  With the clinical research industry experiencing continued growth,It only makes sense then that clinical research professionals need continuing education to keep up with a rapidly evolving industry.

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Topics: Sandra Maddock, Training, GxP Lifeline, Clinical Research

Inclusion and Exclusion - Behind the Scenes

Posted by John Lehmann on Wed, Jul 15, 2015

Investigational plans, or protocols, are developed with what authors believe are clear inclusion and exclusion criteria that must be confirmed prior to the initiation of any investigational treatment or test.  There are certain inclusion criteria that are common including an age range, willingness to provide consent and adhere to the study schedule, and particular condition or diagnosis. Common exclusion criteria include a past medical diagnosis, excluded treatments or medications, or family history of a certain disease. According to 21 CRF 812.110 (b), it is the investigator’s responsibility to conduct the trial according to the investigational plan and therefore, adequately review medical history, interview the subject, and obtain labs or imaging to confirm that all inclusion and no exclusion criteria are met..

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Topics: Inclusion Criteria, Exclusion Criteria, 21 CRF 812.110 (b)

Site Selection - What to Look For?

Posted by Ashton Steinhagen on Thu, Jul 09, 2015

Selecting clinical sites for research purposes may be a difficult and seemingly overwhelming task  for a sponsor.  Familiarity with a site might help with selection, but multiple contributing factors can influence whether or not a site is ultimately chosen.  Choosing the wrong sites could have a detrimental effect on the study including:

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Topics: Sponsors, Site Selection, FDA

2014 FDA Top Ten Warning Letter Findings

Posted by John Lehmann on Tue, Jul 07, 2015

For the sixth year consecutive year, IMARC is presenting its Top 10 Warning Letter findings for your review. 

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Topics: BIMO Metrics, Top 10, FDA, Warning Letters

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