<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=213807269037206&amp;ev=PageView&amp;noscript=1">
IMARC Blog

Compliance In Focus

FILTER BY:

Newest Post

Posted by Stephani Hulec on Wed, Mar 04, 2015

Case Study – Applying the FAIR Shake™

Since the suicide death of Dan Markingson in May of 2004, there has been a lot of debate as to whether or not the 26 year old psychiatric patient should have been approached to consent to participate in a clinical research trial for the comparison of three atypical antipsychotic drugs. Recently, there has been an article published in the Minnesota Daily about a petition signed by over 3,000 ethicists, researchers and scholars asking the University of Minnesota’s President to review the case to prevent future tragedies at the institution. Such a petition was created due to several errors in processes related to human subject protection.

Topics: FAIR Shake, University of Minnesota, Dan Markingson, IMARC Research

Posted by Brandy Chittester on Wed, Mar 04, 2015

What is the FAIR Shake™?

Topics: FAIR Shake, Whitepaper, 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 John Lehmann on Wed, Mar 04, 2015

IRB Reporting Compliance - Whose Job is It?

Recently, when discussing Institutional Review Board (IRB)  adverse event reporting, a Project Manager for a leading medical device Contract Research Organization (CRO) brought up a valuable question regarding reporting compliance- whose job is it to ensure an investigator is compliant with IRB reporting policies?

Topics: FAIR Shake, Contract Research Organization, Reporting Compliance, IRB

Posted by Danielle Sas on Wed, Mar 04, 2015

Case Study – Applying the FAIR Shake™

Since the suicide death of Dan Markingson in May of 2004, there has been a lot of debate as to whether or not the 26 year old psychiatric patient should have been approached to consent to participate in a clinical research trial for the comparison of three atypical antipsychotic drugs. Recently, there has been an article published in the Minnesota Daily about a petition signed by over 3,000 ethicists, researchers and scholars asking the University of Minnesota’s President to review the case to prevent future tragedies at the institution. Such a petition was created due to several errors in processes related to human subject protection.

Topics: Informed Consent Process, FAIR Shake, 21 CFR 20, IMARC Research

Posted by Jacqui Lingler on Fri, Jun 03, 2016

Informed Consent Revisions - Using the FAIR Shake

It is a common question that follows an informed consent document revision- does the subject need to re-sign? The answer could be yes or no depending on the type of revision that was made to the document. 

Topics: Informed Consent, FAIR Shake, IMARC Research, Clinical Monitoring

Posted by Jacqui Lingler on Wed, Mar 04, 2015

The FAIR Shake™ - For TSA?

IMARC clinical monitors are constantly on the go monitoring in the field, from California to Connecticut, Vancouver to Miami.  The monitors are no strangers to airport security lanes and the Transportation Security Administration agents (TSA).  Some may even creatively compare monitors to TSA agents. Both groups of people are required to be familiar with federal regulations. The regulations exist to allow for monitors and TSA agents to execute their primary role; ensuring safety. Monitors ensure the safety of subjects in clinical trials and ensure compliance to 21 CFR 812 (device) or 21 CFR 312 (drug). TSA agents ensure safety of travelers and flight staff as well as ensure compliance with FAA regulations.

Topics: FAIR Shake, 21 CFR 812, Clinical Monitoring

Posted by John Lehmann on Wed, Mar 04, 2015

What Makes a Good Monitor?

Well it’s no secret that our industry is a fan of acronyms. Acronyms are widely used as helpful mnemonic devices to remember important or useful information. And, let’s face it- from examples like ALCOA to FAIR Shake, they’re just too good to stop using! Here’s another to add to the list that revolves around monitors.

Topics: ALCOA, Good Monintor, FAIR Shake, Acronyms

requestconsult-bg.jpg
Clinical Research Training Requirements
Featured Resource

clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.