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Supervisory Responsibilities of Investigators

Jane Marie Johnson
This DRAFT guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biologic, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)).
from Jane Marie Johnson


Adverse Event Tracking Log

Jamie Hodgson
This document is used to log adverse events. If you use an EMR that does not have an Adverse Event tool, then this can be copied and pasted into a blank note in the EMR.
from Jamie Hodgson

Question Concerning AEs Related to the Disease Under Study

Terri Kelly
There is no Guidance or regulation that specifies whether AEs related to disease under study should or should not be reported.
from Terri Kelly


Training Coordinators

Vincent Dorval
I do agree that the training of coordinators is very different from site to site. In fact, we see people with different academic background apply to do the work but what do they know, what do they need to know before begining to work?
from Vincent Dorval





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