Conduct Clinical Trials as a Primary Investigator

Clinical investigations are pivotal in the development of new drugs, expanded drug indications, and improvement of existing therapeutic approaches in the treatment of illness and disease.  Physicians in private practice are in a unique position to recruit appropriate patients for these study trials.  Through participation in clinical trials, physicians:

• Contribute to research within their specialty or therapeutic area
• Provide an opportunity for patients to receive new medications
• Engage in professional development
• Receive professional recognition
• Obtain financial compensation

Role of the PI in a Clinvest Research Project

The Investigator

Each investigator in every study is called upon to thoroughly consider and screen qualified patients for enrollment. Following selection, it is the responsibility of the investigator to assure complete confidentiality and adherence to the responsibilities defined by the basics of Good Clinical Practice (GCP), the FDA, and the study sponsor.  This will minimally include an agreement to:

• Conduct the study in strict accordance with the protocol
• Personally conduct or supervise the investigation  
• Ensure the Informed Consent procedure and IRB processes are performed according to applicable regulations, and that no deviation will be made in the research without prior institutional review board approval - except where needed to eliminate immediate hazards to human subjects
• Document and manage adverse events
• Assure that all associates assisting with the conduct of the study are informed of their obligations
• Assure study records are accurate and available for inspection according to FDA regulations