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Relevant Guidelines of CDM
All clinical research data should be recorded, handled, & stored in a way that allows its accurate reporting, interpretation & verification. (ICH GCP 2.10, 4.9, 5.5, 5.14 & ICH E9 3.6 & 5.8).
Systems with procedures that assure quality of every aspect of research should be implemented. (GCP 2.13)
Quality assurance & quality control systems with written standard operating procedures should be implemented & maintained to ensure that research are conducted & data are generated, documented & recorded, & reported in compliance with protocol, GCP & applicable regulatory requirements. (GCP 5.1.1)
If data are transformed during processing, it should always be possible to compare original data & observations with processed data (ICH GCP 5.5.4)
Sponsor should use an unambiguous subject identification number or code that allows identification of all data reported for each subject. (ICH GCP 5.5.5)
Protocol amendments that necessitate a change in design of CRF, subject diaries, study worksheets, research database & other key aspects of CDM processes need to be controlled. (ICH E9 2.1.2)
Common standards should be adopted for a number of features of research such as dictionaries of medical terms, definition & timing of main measurements, handling of protocol deviations. (ICH E9 2.1.1)
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