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Shawn Kennedy

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Posted by Shawn Kennedy on Thu, Nov 12, 2015

What is the FDA Form 3674?

Recently, while on a monitoring visit for a physician sponsored IDE study in which IMARC was concurrently conducting a clinical audit, I was caught off guard by the question “do you know what the FDA Form 3674 is?”  I thought I had spent a good deal of my professional career working in the clinical research industry, I try my best to be a diligent student of the regulations and GCP guidelines, and even have tested my wits by passing the SOCRA certified clinical research professional exam.  However, I was stumped when it came to this mysterious form, albeit somewhat relieved that my co-monitor and the auditor that asked me were equally baffled by what it was.  At our auditor’s good suggestion, we took to finding the answer.  That night, she emailed FDAs FDAs gcp.questions@fda.hhs.gov for their input.  This is really a fantastic tool in and of itself if you have not utilized it, someone from FDA will respond to your questions regarding good clinical practice in the field of clinical research.

Topics: 510(k) Program, Clinical Auditing, FDA, Form 3674

Posted by Shawn Kennedy on Thu, Oct 22, 2015

New FDA Draft Guidance: Revised ICH Guidelines for Good Clinical Practice

Recently, FDA issued a new draft guidance document through their online email notification system regarding proposed revisions to the ICH GCP Guidelines for Good Clinical Practice.  The draft guidance, titled “E6 (R2) Good Clinical Practice,” is currently in what FDA calls “Step 2 of the ICH Process,” which means that it was released for feedback by the ICH Steering Committee on 11 June 2015 to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Canada, and Switzerland).  This is very exciting news for the clinical research community, as the ICH GCP Guidelines have not been updated since they were originally released nearly 20 years ago in 1996. 

Topics: Good Clinical Practice, ICH GCP, Draft Guidance, FDA

Posted by Shawn Kennedy on Thu, Sep 24, 2015

The Common Rule (1991)

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.

Topics: History of Clinical Research Timeline, IMARC Research, The Common Rule

Posted by Shawn Kennedy on Thu, Sep 03, 2015

International Conference on Harmonisation (ICH): 1990

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.

Beginning in the 1980’s, Europe began the push for harmonizing regulatory requirements, primarily to create a single market for pharmaceuticals at the time.  More specific plans were developed at the World Health Organization Conference of Drug Regulatory Authorities in 1989.

Posted by Shawn Kennedy on Wed, Jul 22, 2015

FDA Regulations - Title 21: 1981

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

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

Posted by Shawn Kennedy on Wed, Jan 03, 2018

IMARC University Course Catalog: Available Now!

We are excited to have recently launched IMARC University, our latest service offering designed to make clinical research education more widely available to the industry.  IMARC University is a series of affordable online training and continuing education courses designed to prepare you and your team for clinical research compliance.  These courses cover many aspects of the clinical research process, from FDA regulations and Good Clinical Practice standards to adverse event reporting and how to conduct monitoring activities.  All courses can be taken at your own pace.  We can even create and customize additional training to meet the needs of your team.

Topics: IMARC University, Online Training, Course Catalog

Posted by Shawn Kennedy on Wed, Mar 04, 2015

FDA Kefauver-Harris Amendment (1962)

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.

Topics: History of Clinical Research, Kefauver-Harris Amendment, IMARC Research, FDA

Posted by Shawn Kennedy on Mon, Nov 06, 2017

The Tuskegee Syphilis Study (1932 – 1972)

As we continue to blog about the events that comprise our History of Clinical Research: A Timeline, we focus this month on the infamous Tuskegee Syphilis Study.

Topics: History of Clinical Research Timeline, The Tuskegee Syphilis Study, IMARC Research

Posted by Shawn Kennedy on Mon, Nov 06, 2017

New Draft Guidance Released: Informed Consent Information Sheet!

It should come as no surprise that FDA has released a new draft guidance regarding informed consent.  Every year, FDAs Bioresearch Monitoring Program (BIMO) releases summative information on the results of the inspections they have conducted on their website.  The results of the inspections conducted are a yearly focus of IMARC as we try to make sense of what the FDA is most concerned with regarding the conduct of research involving human subjects.  Almost inevitably, the most frequent citation from an FDA inspection at a clinical investigation site pertains to improper or inadequate informed consent.  Given that informed consent is one of the most important parts of the research process, it makes sense in that FDA is sharing yet again their “current views” on the concept.

Topics: New Draft Guidance, Informed Consent Information Sheet, FDA

Posted by Shawn Kennedy on Wed, Jan 03, 2018

What Makes Good Clinical Research Training?

Recently, we have noticed an increase in the demand for training across the clinical research landscape.  This should come as no surprise with the constant advances in technology improving the way that clinical research studies are conducted.  Those of us involved in this privilege are continually striving to keep up, and continuing education is a regular part our profession.  In addition, FDA regulations require that individuals involved in the clinical research process be qualified by training and experience.  But what constitutes “adequate” training?  This a question often asked of us by the sponsors and investigators we work with.

Topics: FDA Regulations, IMARC Research, Clinical Research Training

Posted by Shawn Kennedy on Wed, Mar 04, 2015

openFDA – A new FDA program to Increase Transparency

Topics: openFDA, Freedom of Information Act, FDA, HIPAA

Posted by Shawn Kennedy on Wed, Mar 04, 2015

Pure Food and Drug Act – 1906

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 calendar year.

Topics: History of Clinical Research Timeline, Pure Food and Drug Act – 1906, FDA

Posted by Shawn Kennedy on Wed, Mar 04, 2015

1747 - James Lind

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 calendar year.

Topics: History of Clinical Research, James Lind, IMARC Research

Posted by Shawn Kennedy on Wed, Mar 04, 2015

The Book of Daniel – 605 BC

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 calendar year.

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

Posted by Shawn Kennedy on Mon, Nov 06, 2017

The Hippocratic Oath – 500 BC

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 calendar year.

Topics: History of Clinical Research, The Hippocratic Oath, IMARC Research

Posted by Shawn Kennedy on Wed, Mar 04, 2015

IMARC Poll: What is your Favorite Regulation and Why?

We recently took a poll within the company regarding the following topic:  What is your favorite regulation, and why?  Here are some selected responses and the reasoning behind them:

Topics: FAIR Shake, 21 CFR 812, Federal Regulations, IMARC Research

Posted by Shawn Kennedy on Wed, Mar 04, 2015

Where do all the Adverse Events Go?

Topics: Adverse Events, The Declaration of Helsinki, Clinical Monitoring

Posted by Shawn Kennedy on Wed, Mar 04, 2015

On the Twelfth day of Clinical Research…The FDA gave to me…

If you work in clinical research, chances are you are familiar with the FDA regulations (21 CFR and all of its parts). If you’re like me though, you may have a strong understanding of these regulations but still need to reference a regulatory book from time to time if you want to be sure or cite something. Well IMARC’s present to you this year is a quick reference guide for regulatory time requirements for Investigators and Sponsors of medical device research, as well as IRBs. For space sake, we are paraphrasing. Please don’t feel obligated to get us any gifts in return. You can give the gift of human subject protection to every research subject involved simply by striving to meet these requirements.

Topics: FDA Regulations, Sponsors, IRB

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Clinical Research Training Requirements
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