Introduction to Monitoring

monitoring tools to save you time

I’ve been out on the road for the past few weeks assisting some other monitors to review patient’s medical records and the data that has been collected for the clinical trial. It occurs to me, that it would be beneficial at this point to further describe to you the roles and expectations of a Clinical Research Associate (CRA).

In a pharmaceutical/biotech company, teams of scientists are working to discover new molecules, compounds, and foundations for new drugs. In addition, these same scientists sometimes work to re-formulate current drugs or apply them for new diseases and indications (all of this work is done in animal models before the human clinical trials can begin). It is at this point that monitors such as myself come into play. Once an experiment that involves humans is designed, monitors help the company choose qualified and interested physicians to carry out the study. These ‘investigators’ are reimbursed for their efforts to conduct the trial and a CRA may also help negotiate the budget and/or contract between the parties involved.

Monitoring at an obscure location
A CRA job is a traveling job. Sometimes we go to glamorous places but more often than not we are monitoring in hard to reach or otherwise obscure locations. 

Objectives when we visit the investigative site (Doctor office, hospital, research center, etc.) include: 1) perform pre-study tasks during a Pre-Study Visit (PSV), 2) kick-off the study with a Site Initiation Visit (SIV), 3) routinely check back with the site regarding subject enrollment, trial conduct, and data collection during one (or typically many!) Interim Site Monitoring Visits (MV), and finally 4) shut down the site after their participation has ended during a Close Out Visit (COV). Before and after each visit, there are a variety of tasks and communications that need to occur in regards to preparing for, scheduling, confirming, and then following up on items from previous visits. Read some of my other blog posts to learn more about Site Initiation Visits, Routine Monitoring Visits, and Close-Out Visits.

Also, between visits, a CRA needs to regularly contact the sites and perform site management activities such as answering questions regarding the study design, encouraging enrollment, sharing tips from other sites, and distributing study drug (Investigational Product, IP), and managing site supplies inventory levels (often you are assigned up to 10 different sites to manage but this really can vary depending on geography, how many patients/doctor sites are participating, how many monitors are on the study, how complex the trial is, and a variety of other factors).

I’ll explain more regarding the key tasks at each visit in later articles. There are many Federal and International regulations that apply to human research to ensure that the studies are valid, reliable, and above all, that the rights of the participating subjects are protected and we’ll also get into those soon.

Business Travel Safety
Pre-Study Visits and Site Initiation Visits
About The Author

The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at leadcra@clinopstoolkit.com anytime.

5 Comments

  • Vinendra

    September 6, 2015

    It’s good information, but improve update .

  • s sekhar

    July 10, 2014

    Hello Nadia,

    Your blog is so helpful for my interviews. Really thankful to you. If an interviewer ask me a question like
    ” As a CRA how do you organize your work? and what skills do you use to run your monitoring visit smooth?”
    What should be the best answer for this question? Please help me.

    Thanks in advance,

    Sekhar

    • Nadia

      Nadia

      July 19, 2014

      Hi Soma, I had a great foundation to monitoring from my friend and mentor, Annmarie (link to the interview). She believes that quality follow-up and confirmation letters are the best tools for organizing prior to a monitoring visit. I have gotten into the practice of working on my monitoring report before I go to the site. I mock up all my answers and highlight them. Then I am envisioning what a successful monitoring visit looks like. I read through my emails since the last visit to see if there are any salient points I want to include in my report or specific things I want to review while I am on site. This always helps me be prepared and write a good confirmation letter. Throughout the visit I review my templated answers and expand or revise them as needed. Mocking up your final report before you even arrive is the best tool for success in my opinion.

  • Kayode Olowomeye

    January 18, 2014

    I love this blog, very informative and educative. Keep up the good works Nadia.

    • Nadia

      Nadia

      February 7, 2014

      Hi Kayode, Thanks for leaving this comment. I hope you found the Introduction to Monitoring article and other resources helpful. Glad you stopped by!

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