How to Become a Clinical Investigator

A Clinical Investigator, usually a scientist or doctor, is a person qualified by education and experience to conduct clinical trials. If there are others assisting with the clinical trial, the Clinical Investigator is the leader of the investigational team and generally referred to as the Principal Investigator or PI. The Clinical Investigator must delegate responsibilities to the other team members and ensure they are carried out legally and appropriately. If you’re interested in conducting clinical trials, follow these steps to become a Clinical Investigator.

Difficulty: Moderate

Instructions

Things You'll Need:

• Basic GCP knowleged

1. Assess your time. Review your schedule, in depth, and determine if you have the time to conduct clinical trials. The Food and Drug Administration (FDA) inspects clinical trial sites and one of the biggest citations is the “lack of oversight”. This means the Clinical Investigator did not take time to watch what the other team members were doing and many of them were not doing the delegated task right. More often than not, some of the things they did were illegal. As the Clinical Investigator, you’re responsible for their actions in accordance with agreements you will sign, such as FDA-Form 1572.

2. Secure an office or facility. Do you have a medical office or are you affiliated with a hospital? You need a location where people can come for appropriate protocol required visits. At a minimum, you will need a waiting room, examination room and a place to lock-up investigational products.

3. Get basic medical equipment. Almost every clinical trial involving human research requests a physical examination for the subjects, therefore, typical examination equipment should be present. Such include blood pressure equipment (not the digital kind!), ECG machines, and other emergency equipment.

4. Check your research knowledge. To conduct research, you must have more than your medical knowledge. You need to know what the law requires regarding clinical research and the treatment of human subjects. Specifically, you need to know what the FDA and other applicable local and state laws require of a clinical investigator. You need to know common industry acronyms and terminology such as CRF (Case Report Form), ICF (Informed Consent Form) and much more. A great training source can be found here: http://www.wqats.com/Training.html.

5. Network. If you’re going to do clinical trials, you’re required by regulations to be able to produce patients for the sponsor who meet the applicable enrollment criteria. Networking with other doctors (or scientists) allows you to request referrals from them. Most protocols do not permit patients to be re-used on the same investigational product. For example, if you’re doing a Phase II clinical trial with Joe Blow on investigational drug VOII, then Joe Blow may not be eligible for the Phase III clinical trial on VOII. Therefore, you must be able to produce other patients.

6. Get Certified. I’m big on clinical research certification, so yes, even though you have a MD behind your name, I recommend you become certified as a clinical investigator. Why? Because I’ve seen too many doctors lose money and almost lose their medical license because they did not know the person they hired to run their clinical trial was doing illegal practices. As the PI or Clinical Investigator, your reputation (and possibly your freedom) is jeopardized. Read this blog http://wqatsqatalk.blogspot.com/ and learn why it’s important that you become certified as a clinical investigator. The Association of Clinical Research Professional (ACRP) has a good program for this certification.

7. Hire a qualified Clinical Research Coordinator. A smart Clinical Investigator finds a good Clinical Research Coordinator and holds on tight. A good Clinical Research Coordinator could take 75% of the workload off of a Clinical Investigator as they concentrate on required regulatory and sponsor documentation letting the PI concentrate on the patients. For more information on selecting a qualified CRC, check out this article: http://www.ehow.com/how_2353380_choose-qualified-clinical-research-coordinator.html.

Tips & Warnings

• Make sure you have the time to see patients and perform all of the task required by the protocol before accepting a clinical trial.
• Serve as a sub-investigator on a clinical trial before becoming a principal investigator. As a sub-investigator, you receive good training on the clinical trial process and the role of an investigator.
• Take trials you are really interested in. If you’re a cardiologist, it makes sense for you to take a cardiac trial more so than a sleep apnea trial.

Resources

• Wilson Quality Auditing & Training Services, LLC
• QA Talk Research Misconduct Part II

[2besure]

on 6/24/2008 Thank you for making me aware of this position. Very good article.