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when you get assigned to a study you just know that these are the documents that need to be filed in the ISF and in the etmf and you donamp;#39;t really know why you just know that you have to and then you slowly understand then all these requirements that we have in clinical trials come because of Regulation and we need to comply with it and we need to have these documents properly filed because of Regulation itamp;#39;s section eight and it categorizes these documents in three main section sections documents that are generated before the trial conduct documents that are generated during the conducts or operations and then those that are generated at the end of the contact usually what I think of these documents as being crucial because they prove three things they prove that the site Personnel is qualified and they are acting and conducting the child ing to regulation and the protocol thatamp;#39;s the proof that we have right CVS gcp certificate the software tools certificates th
