FAQ

1.Clinical trials require a fair amount of management and documentation. You will probably want someone to handle that for you, most likely someone who is already on your staff. GCP training will provide tips for incorporating a clinical trial into your day-to-day practice.

2.The most important factor in determining if you are a good fit for overseeing clinical trials is a thorough understanding of the commitment needed to conduct a clinical trial. Many physicians find that being an investigator can be a challenging, but rewarding, experience. When considering a specific trial, you may want to ask yourself: Does this trial fit my patient population? Is there an adequate patient population to meet enrollment goals? Do I have the necessary equipment to conduct this trial? Does my practice have the ability to store investigational products properly? Do I have adequate staff to perform the responsibilities of this trial? What would be the compensation to me for participating? Am I, along with my staff, committed to all that will be involved in this trial?

3.Clinical trial investigators play an integral role in the development of new medicines and medical devices used to help combat disease, treat chronic and degenerative diseases, and improve the health of people worldwide. There is a continual need for physicians in private practice to join in the pursuit of advancing medicine as clinical trial investigators. Advantages of conducting clinical trials include: Professional development: Be on the cutting edge of your therapeutic area of expertise, meet other investigators, exchange ideas, plan future collaborations, and work with investigational medications and processes that are not yet approved by the FDA. Professional recognition: Use your role as an investigator to co-author articles for publication and be recognized as a thought leader within the medical community. Personal satisfaction: Offer your patients new medical treatments that may only be available through participation in clinical trials New revenue stream: Add additional revenue to your medical practice, based on compensation provided by sponsors for your time spent conducting clinical trials. Role in the advancement of medicine: Be a leader in your field by potentially bringing breakthrough drugs and medical devices - products that could impact the health of people around the world - to market.

4.You must have a basic understanding of good clinical practice (GCP) before you can participate as a clinical trial investigator. GCP refers to the principles and processes investigators worldwide are expected to follow. Good clinical practices are in place to ensure the safety and privacy of study participants. You will also need a thorough understanding of the principles of conducting clinical trials as well as the ethical and regulatory requirements. You can learn more about GCP and how to become a certified investigator through the Academy of Pharmaceutical Physicians and Investigators. However, certification is not required to become a clinical trial investigator. The Drug Information Association is also a good resource