In a previous post, we mentioned the fact that you may be wasting your time and money trying to complete a so called CRA or clinical research training program only to find out you remain out of a clinical research job after having completed that training. A couple of our colleagues who were trying to transistion to the clinical research field as CRAs or CRCs got suckered in and will never forget this painful experience. Three of our colleagues signed up for and paid their hard-earned money on three different clinical research programs and actually completed those programs only to their dissatisfaction and disappointment: NO JOB, NO INTERVIEW, NO NOTHING! JUST A WASTE OF CA$H! In our previous post entitled "You May Never Become a CRA: Blame Your CRA Training Provider or Program", we compared some of those training programs to the FDA's blacklist of principal investigators. We said anytime employers see those "phony" guys listed on your resume, they'll just ignore your bid for the job. This a subject that really angers us here, and we hate to see other innocent people fall prey to some of those "fake" training programs. You need some names listed here, and we know it. Please continue reading.

The investigator meeting is a very important phase in the drug development program. This is an important meeting and the sponsor personnel tasked with conducting this meeting (could be the clinical research associate) must fully prepare for that meeting weeks in advance! It is during this meeting that crucial personnel members from both the sponsor and investigative site will have an opportunity to meet and interact. During this meeting, the person conducting the visit (could be an experienced CRA or other sponsor-designated personnel) will get everyone acquainted with the protocol and trial related activities. Here are some of the activities that may be discussed during this meeting:

• Study objectives
• Study visits and randomization procedures
• CRF completion guidelines
• Financial matters
• Sponsor/investigator responsibilities
• Consenting and the Informed Consent process Add a comment

A study may terminate/close for a variety of reasons. Some of those reasons include but are not limited to the following:

• the study has successfully complete
• enrollment goals cannot be met
• safety reasons (the drug has proven to be too unsafe)
• efficacy reasons (the drug has proven to be so effective that continuing with the study is not necessary)
• the investigator has died and there is no matching replacement
• repeated fraud and misconduct
• financial reasons (not enough funding or sponsor can no longer afford to run the trial)
• etc.

Whatever the reason or reasons may be, an official study termination visit is needed and the sponsor monitor is responsible for this task. The person conducting this visit must prepare and send a study termination confirmation visit letter, detailing the items to be discussed at that meeting with the PI and staff and the date of the visit. This form outlines the termination visit activities. Download the sample Study Termination Visit Letter/Report.  Please share your thoughts below.