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Being certified means I have an easier time doing my work. As the owner of a small, boutique CRO (with no advertising budget), my CCTI credential means my word-of-mouth customers will have some confidence in my knowledge and skill. The ACRP certification carries a level of credibility to help people who don’t know me. The certification helps to convey my intense interest in leading clinical trials in a credible and helpful manner. For the non-significant risk trials where a medical monitor would be a partner with me, the certification helps my clients to understand I have the training and experience to conduct the trial, keep the study subjects safe and manage the data in a responsible way.
ACRP is growing and advancing. One way to see this growth is in this particular certification contest and in the consistent quality improvements in the certification exams and credentialing processes. One change directly affecting me is the soon to be name change for my credential from CCTI to CPI as ACRP is moving to change this certification moniker to be more inclusive and consistent with the regulations. I believe this is a great idea!
For many years, I have had discussions with other PIs (most of them physicians) and we have wondered what it would take to get more research investigators to become certified. At the Mayo Clinic when I was Operations Manager for the Mayo Clinical Trials Services unit, we often had training programs and visits from investigators working in many parts of the world. We all agreed more training is helpful when the training is directly applied to the projects at hand. As the global trials become more complex and the regulations become more advanced as well as globally harmonized, new ethical boundaries are being explored. The need for a unified principal investigator certification standard is a worthy goal to help us set the bar to define these new ethical boundaries.
Another area of great discussion surrounded the concept about the rapid expansion of clinical research activities. For example, we now have good standards to support not only newly designed interventional trials for drugs (ICH E6), but also for new medical devices (ISO 14155) and we have claim substantiation guidelines for dietary supplements (FDA Guidance) explaining the number and types of clinical trials needed to have sufficient scientific rigor when supporting a marketing claim for a dietary supplement. The variety of clinical trials and the need to better understand how to reduce costs and improve quality are finally center stage. Discussions about risk based monitoring and complex reporting issues to identify signals faster and to ensure safety sooner are common place and the need for excellent, certified principal investigators has never been greater.
A unified standard and a common goal to improve the quality of clinical research are what my new CPI designation means to me. Since taking the exam in March of 2007, I have started two businesses, completed dozens of clinical trials and mentored dozens of individuals interested in clinical research. The certification was one of the big steps on my way to developing the confidence I needed to succeed.
ACRP is growing and advancing. One way to see this growth is in this particular certification contest and in the consistent quality improvements in the certification exams and credentialing processes. One change directly affecting me is the soon to be name change for my credential from CCTI to CPI as ACRP is moving to change this certification moniker to be more inclusive and consistent with the regulations. I believe this is a great idea!
For many years, I have had discussions with other PIs (most of them physicians) and we have wondered what it would take to get more research investigators to become certified. At the Mayo Clinic when I was Operations Manager for the Mayo Clinical Trials Services unit, we often had training programs and visits from investigators working in many parts of the world. We all agreed more training is helpful when the training is directly applied to the projects at hand. As the global trials become more complex and the regulations become more advanced as well as globally harmonized, new ethical boundaries are being explored. The need for a unified principal investigator certification standard is a worthy goal to help us set the bar to define these new ethical boundaries.
Another area of great discussion surrounded the concept about the rapid expansion of clinical research activities. For example, we now have good standards to support not only newly designed interventional trials for drugs (ICH E6), but also for new medical devices (ISO 14155) and we have claim substantiation guidelines for dietary supplements (FDA Guidance) explaining the number and types of clinical trials needed to have sufficient scientific rigor when supporting a marketing claim for a dietary supplement. The variety of clinical trials and the need to better understand how to reduce costs and improve quality are finally center stage. Discussions about risk based monitoring and complex reporting issues to identify signals faster and to ensure safety sooner are common place and the need for excellent, certified principal investigators has never been greater.
A unified standard and a common goal to improve the quality of clinical research are what my new CPI designation means to me. Since taking the exam in March of 2007, I have started two businesses, completed dozens of clinical trials and mentored dozens of individuals interested in clinical research. The certification was one of the big steps on my way to developing the confidence I needed to succeed.
