Common Audit Findings - Informed Consent

Dec 22, 2020

Hi, Elizabeth here, and welcome!

In this post I will begin discussing common audit findings, and one of the first ones I think of involves informed consent.  This is a big one.  By the end of this post, you will learn some of the common audit findings regarding consent and some tips that will assist you when monitoring.

So, let us start with the common issue regarding subjects not consented with the correct version of the Informed Consent Form (ICF).  Yikes, right!!  Unfortunately, this happens a lot.

As you may know, when a subject is consented, the most current IRB approved version of the consent form should be used, and we see issues with this a lot as monitors.  You may see the newest IRB approval filed in the Regulatory Binder; however, the new subject did not sign this version.  It ends up the subject signed a previous version.  

This is one of the reasons why during my first visit to a site, I like to start with the Regulatory Binder. ...

Continue Reading...

Monitoring Visit Reports

May 08, 2020

Hi, Elizabeth here, and welcome!

In this post I will be discussing the infamous monitoring visit reports, also known as MVRs, or trip reports. I know this does not sound like the most exciting topic, but it is extremely important as it is a huge part of the CRA career.

So, are you with me? You can do this, LOL!

Again, not the most interesting topic, but hang in there.

There will be many good tips to help you with monitoring visit report completion.

So, for those of you that don't know, let's start with the guidelines. Per ICH/GCPs, the monitor should submit a written report to the sponsor after each trial site visit or trial related communication.

The guidelines also state what each report should include, and I'm going to just summarize this part….It should include a summary of what the monitor reviewed, any significant findings, facts, deviations, deficiencies, and actions taken or to be taken. So, because of this, when you work for a company, there should be SOPs, Standard...

Continue Reading...

Review and Discussion of FDA Guidance Regarding COVID-19

Apr 08, 2020

Hi, Elizabeth here, and welcome!

This post relates to a very important soft skill….being able to adapt to change.  There is an example now causing so many changes, affecting all areas of the clinical research industry, COVID-19 which is the Coronavirus Disease 2019.

Because DHHS, the Department of Health and Human Services, and the president declared this a state of emergency, the FDA recognizes that this pandemic is going to impact the conduct of clinical trials. All areas of research are being affected during this crisis from investigators and site staff to sponsors to CROs, which includes CRAs, study management, CTAs, Data Management, Medical Writers, Statisticians, and more. Due to this, the FDA provided guidance for industry, investigators, and Institutional Review Boards regarding the conduct of clinical trials of medical products during the COVID-19 pandemic.

The guidance provides general considerations to assist sponsors in assuring the safety of trial...

Continue Reading...

CRA Challenges With Time Management

Jan 03, 2020

What do you first think of when you hear Clinical Research Associate? The first thing that comes to mind is travel for sure.  Other than that, do you really know what their day to day activities consist of, as well as, what they must balance and multitask?  There are many deliverables a CRA must balance between visits while still being on-time. I definitely learned that when I would go to these places, I didn't really get to venture out as much as I thought I would LOL. 

The staff at the airport would pick on me, and say that it was a waste for me to go to West Palm Beach.  They would ask me if I was going to the beach, and I would answer, “No, I'm probably going to head back to the hotel room and get some work done before the next day at the site”...(It was nice when I had an ocean view though, so I at least got to enjoy a little bit of the ocean)...One day I proved it to them LOL. I went out to the beach after work, and I had to take a picture to...

Continue Reading...

Introduction To The CRA Helper And How The Journey Began

Dec 31, 2019

Hi and welcome!!  This is my FIRST blog ever, so it is definitely another milestone for me LOL. In this post, I wanted you to have a chance to know me better, while giving you additional details regarding my background and experience.

Well, I've been in the clinical research industry over 18 years, and as a manager, I interviewed many aspiring CRAs. So, I know that we all have a different story to tell regarding how we got our start in the industry, and how we got our foot in the door.  It's so funny because when I go to a face-to-face meeting, like an Investigator Meeting, or even to a site with a co-monitor, one of the first things we talk about is how we started in our CRA career.  You could have a whole team of Clinical Research Associates with different pathways of how they got started in the role. 

So, here's my story:

I went to Campbell University in Buis Creek, NC.  Gooooo Camels!!  I was one of those students that changed their majors...

Continue Reading...
Close

50% Complete

Two Step

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.