Tuesday, April 13, 2010

How to prepare a questionnaire to know that investigators conducting clinical trials are GCP trained or not?

I am a CLINICAL RESEARCH STUDENT and am preparing a thesis on implementation of ICHGCP guidelines....and so i need to prepare a questionnaire regarding trained GCP professionals

How to prepare a questionnaire to know that investigators conducting clinical trials are GCP trained or not?
I'm not sure if you want to test the investigators by giving them a questionnaire with multiple choice, short answer, or essay questions ... or do you somehow want to get proof from them that they have completed GCP training?





With regard to the second approach, most of them should have a certificate from whatever training they took. They should be able to give you a copy of the certificate to prove that they have been trained.





With regard to the first approach, you can make up a test and give it to them. I'm not sure what your thesis question might be, but you could construct your test around your particular questions of interest.





I think you will find that a lot of investigators will claim to have been trained (or have actually been trained), but may not remember all the specifics of GCP. It is why most companies have fairly close monitoring of clinical trials by people outside of the institution where the trial is being run.


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