CIT 2010 Daily News March 31， 2010

  The 2nd Clinical Research Workshop A One-Day Course for Physicians and Research Coordinators A GCP Certification Course
Session 1 9:35 A.M Jenny Zhen Qin

  In her presentation entitled “Responsibilities of Investigators in Clinical Trials: From Consent to Safety Reporting (GCP Principles and Standards) to Managing Monitor Visits and Audits， Professor Jenny Zhen Qin of the USA gave an overview of the regulations related to clinical trials and many of the key responsibilities of investigators.

  Professor Qin discussed regulations and guidance in the USA as guided by FDA regulations and briefly touched on SFDA regulations as well. In the US， there are guidelines for both investigators and industry. Guidance for industry clarifies for industry the responsibilities for investigators and proper training for staff. The investigator has many responsibilities and guidelines for all stages of a trial. One key area mentioned by Professor Qin was the requirement of informed consent. She stated， “Informed consent is a process and not just a matter of giving it to the patient to sign.” That means that all the patients’ questions must be answered prior to signing of the informed consent. This informed consent then becomes part of the patient’s medical record. Medical care of trial subjects is a great importance and this requires communication with the IRB (Institutional Review Board) or IEC (Independent Ethics Committee). In addition， safety is paramount and serious adverse events must be reported to the sponsor and IRB/IEC. Proper safety reporting includes keeping adequate and accurate records. In the case of premature termination or suspension of the trial， the trial subjects must be informed promptly and the investigator must assure appropriate therapy and follow-up. Device trials have their own special guidelines governing device use， storage of devices， disposal of devices upon completion of the trial， and financial disclosure. “Financial disclosure helps to avoid bias in clinical studies due to financial
Interest”， Professor Qin Said. She concluded that as an investigator， “you are like a captain guiding a ship out of port” and “adherence to all standards and applicable regulations is a must to ensure the credibility of the data and well-being of research subjects in a clinical trial are protected.”

  In an interview following her lecture， Professor Qin said， “The take home message for investigators in China is they should try to study and follow these requirements” and “Gradually China will have more and more certified investigators across the board”.