This post is unconventional and perhaps a little unpopular, but it has to be said: more than likely, you are writing and filing TOO many NTFs for missing documents, signatures, and data. Enough is enough! But, there is a limit to what warrants a NTF. If NTFs are used to document every issue, the golden rule can tarnish your research. The citation went on to state that there were an astonishing 89 NTFs generated after a monitoring visit!
Although the study coordinator admitted this wrongdoing and resigned from your practice, as the clinical investigator you maintain overall responsibility for the conduct of this clinical investigation.
Your failure to maintain adequate and accurate case histories could potentially compromise the integrity of the data collected during the clinical investigation. You did not obtain prescreening written Informed Consent for b 4 , b 6. You also provided documentation of staff training regarding this observation.
Your response has been noted; however, the delay in the implementation of the proper procedures is not acceptable. NTFs can do one of two things: they can either help you or hurt you in the reconstruction of the conduct of your clinical trial. Personally, I have performed QC on hundreds yes, hundreds! It is also very important to understand that NTFs do not replace the need for the actual document.
In my experience, most of the NTFs are to document a missing document. I am not sure how much sense it makes to create a NTF to document that a document will not or cannot be collected…think about that for a minute. If the document is not present it is not present; the NTF does not make it magically appear. File extension note is mainly related to Notability for iPad and iPhone app.
NOTE is the default document format of Notability and may contain text, markups, handwriting, drawings or audio recordings. Notability for iPad. Notability for iPad is a handwriting, typical and annotation program for iPad tablet, developed by Ginger Labs, Inc.
With Notability you can capture ideas, share insights, and present information in one perfect place on iPad. Hint: Click on the tab below to simply browse between the application actions, to quickly get a list of recommended software, which is able to perform the specified software action, such as opening, editing or converting note files.
Programs supporting the exension note on the main platforms Windows, Mac, Linux or mobile. Click on the link to get more information about Notability for iPad for open note file action. Click on the link to get more information about Notability for iPad for edit note file action. Click on the link to get more information about Notability for iPad for create note file action. Click on the link to get more information about Notability for iPad for export note file action.
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NOTE file extension - Notability note file.
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