Table of Contents
What happens at an investigator meeting?
An Investigator Meeting is a time for everyone involved with a new clinical trial to meet face to face and get familiar with the study, including learning about the roles in the study.
Who attends an investigator meeting?
Only the principal investigator and one to two research coordinators from each site should be invited to the meeting. It should be made clear that meeting attendance is required and that families or other guests will not be accommodated.
What is a pharmaceutical investigator meeting?
Among the most unique and important meetings for pharmaceutical and life sciences companies are the investigator meetings that bring together healthcare professionals for training on how to participate in the clinical trials that will move their drugs and devices forward.
What are investigators responsibilities?
Investigators are responsible for supervising the proper handling, administration, storage, and destruction of investigational agents (ie, drug accountability). Although these tasks can be delegated to an appropriately qualified individual, the investigator maintains ultimate responsibility.
Do investigator meetings improve recruitment rates in clinical trials retrospective before and after studying data from nine multi center clinical trials?
Conclusion. There is no statistical evidence to conclude that holding an investigator meeting increases recruitment in the 8 weeks following the meeting.
How do you prepare for an investigation meeting?
To ensure that investigation meetings are conducted fairly, professionally and impartially, you should:
- Not fold your arms, as this can appear intimidating.
- Give an appropriate amount of eye contact.
- Be calm and face the interviewee in a relaxed body posture.
What is the purpose of the investigator brochure?
The purpose of the IB is to compile data relevant to studies of the investigational product in human subjects gathered during preclinical and other clinical trials to provide the investigator with information necessary for the management of study conduct and study subjects throughout a clinical trial.
What are the ethical obligations of investigators?
An investigator observes the highest standards of integrity and conduct when conducting an investigation. Investigation participants are entitled to be treated with respect, fairness, moderation, thoroughness and impartiality.
What are the investigator’s legal obligations during the investigation?
obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research, unless these requirements have been waived by the IRB (45 CFR 46.116; 45 CFR 46.117);
What makes an investigator effective and efficient?
Decision making ability – An investigator is a fact-finder. They must resist the temptation to form rash judgements and must disabuse their mind of all prejudices in making decisions. The prospects of success depend largely on the ability to maintain objectivity in making decisions.
What questions do you ask in an investigation?
With that in mind, here are 10 key questions that can help start your investigation:
- Who committed the alleged behavior?
- What happened?
- When did this occur?
- Where did this happen?
- Did you let the accused know that you were upset by this?
- Who else may have seen or heard this as a witness?