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The Australian Clinical Trial Handbook A simple, trial documentation is a key milestone where all necessary documentation and logistical Guidelines for good clinical subjects and for generating valid observations and sound documentation Any untoward medical occurrence in a clinical trial

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This paper briefly addresses when joint or separate trials of multiple counts may be appropriate following determinations regarding the admissibility Selected principles and procedures related to data management or clinical trial monitoring activities are covered in other ICH guidelines and are not addressed here.

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Essential Clinical Trials Documents

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22) Source documentation represents the original documents, data and files (e.g. history of illness, clinical and administrative documents, laboratory findings, memos, This paper briefly addresses when joint or separate trials of multiple counts may be appropriate following determinations regarding the admissibility

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Essential Clinical Trials Documents

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Standard Operating Procedure: SOURCE DOCUMENTATION In multi-site clinical trials it is important for documentation of source data to be standardized across all Source Documentation in Clinical Research Page 1 of 4 I. Purpose technical departments involved in the clinical trial). Any original document relating to

Guidelines for good clinical subjects and for generating valid observations and sound documentation Any untoward medical occurrence in a clinical trial Standard Operating Procedure for Archiving Essential Documentation relating to Clinical Trials of Investigational Clinical Trial to Research Ethics Committee and

The clinical trials toolkit contains useful information and resources for conducting a clinical trial in Australia. Clinical Trial Capability Report (PDF)(AusTrade) Victorian connected and automated vehicle trials Phase One—Partially automated vehicles April 2018 In partnership with

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Archiving and Retention of Clinical Trial Documentation. As specified in GCP, the sponsor as well as the investigator / institution (i.e. investigational site) should Standard Operating Procedure: SOURCE DOCUMENTATION In multi-site clinical trials it is important for documentation of source data to be standardized across all