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Sd Form 572

Sd Form 572

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Video instructions and help with filling out and completing Sd Form 572

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Instructions and help about Sd Form 572

hi there welcome back today we're going to talk about source documentation in case report forms these are gonna be really important aspects of your job as a clinical research coordinator so let's talk a little bit about them so what is a source document I'm Jenna we said that so we're gonna talk about source documentation but what exactly does that mean a source document is defined not in the Code of Federal Regulations oddly enough but it is clearly defined 9 CH all information in original records of clinical findings observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial remember the FDA is going to want to be able to in order to say a drug is safe and effective they might want to go back and look at all those clinical findings and observations so some examples of source documents would be things like lab reports where any kind of radiology report an x-ray MRI that kind of thing EKG readings physician progress notes nurses no

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