In order to better understand the DETAILS of this question, EACH RG Clinical Researcher who will answer this question, MUST first read the attachment to this question OR read the first entry by the author of this question.
The attachment/first entry are identical and will contain: Rationale for this question, Example, Scenario, Issue, Solutions to satisfy Monitor’s requests.
OVERVIEW: How do you
a) Get a monitor to let you know about these things* at the very first monitor visit?
b) Make sure these things* are added to the Source documents before the first subject of the study arrives?
*see attachment or first entry for details
What is YOUR solution? What 'tricks' do you have for developing good Source Documents with good Check- Lists?
Thank you for your input in advance,
I am interested in the various methods, check lists, "thinking", etc that clinical researchers have to make their SD's all encompassing w/o re-writing the who protocol.
Jeanetta Mastron