What documentation should they have available

Reference no: EM133384248

Question: You work for a sponsor and are preparing for a FDA audit of several of your investigative sites who utilize electronic records and signatures in support of the study you are managing. What guidance will you, representing the sponsor, provide to the investigative site to help them be prepared for the FDA auditors, e.g., what documentation should they have available? Why??

In your response, please only provide one element of documentation elaborately

Reference no: EM133384248

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