Why are clinical trials important?
Clinical trials play an important role in the advancement of disease treatment. They are the best way for doctors to learn safety and efficacy of new drug and treatment.
Who can be a clinical trial investigator?
Any practicing doctors can be investigators.
What are the qualifications required to be an investigator?
You should be medically qualified by education, approved training in Good Clinical Practice (GCP), experience to assume responsibility for the proper conduct of the trial, meet all the qualifications specified by the applicable regulatory requirement, and should provide evidence of such qualifications through up-to-date curriculum vitae, GCP certificate and Annual Practice Certificate.
What are the roles of an investigator?
As an investigator, you are responsible for the conduct of a clinical trial at a trial site. You are responsible for all trial-related medical decisions and provide adequate medical care to the patients. You should be familiar with the appropriate use of the investigational product and conduct the trial in compliance with study protocol. You are responsible to ensure that the clinical trial is conducted in accordance with the ethical principles in the Declaration of Helsinki, complies with GCP and the applicable regulatory requirements.
Why should I consider to become an investigator?
As an investigator, you can work towards the greater good of advancing the science and development of new medicines. You can play an integral role in the development of medicines used to treat diseases and improve the health of people worldwide. You have the advantage of offering your patients an opportunity to access new or alternative treatments options that are only available in the clinical trial setting.
What are the things that I need to know as an investigator in a clinical trial?
You must have a clear understanding of GCP. GCP refers to the principles and processes that investigator should follow internationally to ensure the safety and well-being of trial patients. You should be familiar with the study protocol and know whether the trial fits your patient population so that you are able to recruit an adequate number of suitable patients to reach the enrolment goals and within the agreed recruitment period. You should discuss clinical trial participation in a clear and concise manner to your patients. Ensure that your patients are aware and understand the purpose of the clinical trial and their participatory role in the trial. The patients’ participation in a clinical trial is on voluntary basis.
What liability do I have as an investigator in a clinical trial?
The Sponsor will indemnify you against action stemming from a clinical trial as long as you strictly adhere to the study protocol as well as exercise reasonable medical judgement. Your participation in a clinical trial does not have an impact on your insurance premiums.
What are the benefits of being an investigator in a clinical trial?
The benefits are:
- Professional Development – be on the cutting edge in your therapeutic area of expertise.
- Professional Recognition – use your role as an investigator to co-author articles for publication and be recognized as a key opinion leader within the medical community
- Personal Satisfaction – contribution to the advancement of science and medicine. Offer your patients new medical alternatives that may only be available through participation in clinical trials at no cost.
- Equitable Compensation – clinical trials provide compensation for your time and resources