Source Document Agreement

Because the location of the source data may vary from checkpoint to checkpoint, it may be helpful to specify the location of the list. What are the characteristics of source data documents? Several data sets for the same data points, so they can`t determine what serves as an exact source file, for example. B for several versions of analog visual scales completed for the same visit with different values. All transactions performed, including controls, should be documented in detail at the time of each action. The people who complete each task should be clearly identified (operators and controllers). All precautions taken to avoid confusion should be recorded in batch records. Lot records should contain at least the following information: Site should develop a SOP for good documentation. This SOP should be shared with the sponsor/CRO and agreed before the start of the study. This SOP should address aspects, including, but not limited, of consent, authorization verification, the use of instruments such as diaries, source document sheets, OPD documents, copies of prescriptions, etc.; Ways to avoid multiple datasets and, in the case of multiple datasets, to define the source of the study, the method of correction, the verification of security laboratories and other reports. Procedures documented at the site level should include managing, maintaining, archiving and consulting source documentation.

Sites should have measures to improve and maintain quality data. Sites should develop quality control procedures. In accordance with international guidelines, the treating physician (examiner) is responsible for the medical care of each subject (Helsinki Declaration 3 and ICH GCP 4.3). The coding system in blind tests must contain a mechanism for rapid blinding (ICH GCP 5.13.4). If the blindness is prematurely broken, it is the examiner`s responsibility to immediately document each debris and explain it to the proponent (ICH GCP 4.7). (GMP, item 4.18: before starting a packaging operation, it is necessary to verify that equipment and workplace are removed from previous products, documents or materials that are not necessary for the planned packaging operations and that the equipment is clean and fit for use).

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