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Knowing which Essential Documents are required and how best to prepare them will save you and your team time and contribute to the required compliance and success of your clinical trial. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. Ultimately, the goal should be a TMF that has all the documents required to be inspection ready.

ESSENTIELLE DOKUMENTE FÜR DIE DURCHFÜHRUNG EINER KLINISCHEN PRÜFUNG. 1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s) 2. conduct of trials that involve human participants. Review ICH GCP guidance section 8 for a complete list of essential regulatory documentation. 2 The identification of records to be recorded directly into the data acquisition tools (i, no prior written or electronic record of data) and considered to be source data ICH E6(R3) Good Clinical Practice guidance - Step 2 Public.

"The methods used to assure and control the quality of the trial should be proportionate to the risks inherent in the trial and the importance of the information. Essential documents are commonly referred to as regulatory documents. 自从ICH GCP发展以来，临床试验的规模、复杂性和成本在不断增加。技术和风险管理程序的创新，为提高临床试验效率和相关活动带来了新的发展机遇。 ICH HARMONISED GUIDELINE GOOD CLINICAL PRACTICE (GCP) E6(R3). ….

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ICH E6 gave sponsors flexibility to implement. These documents are essential because they serve "to demonstrate the compliance of investigator, sponsor, and.

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. 45 Essential documents should be retained until at least 2-years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2-years have elapsed since the formal discontinuation of clinical development of the investigational product.

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