Validating electronic source data clinical trials Arab chat sex date

20-May-2020 16:19

validating electronic source data clinical trials-33

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Despite this, few regulations talk about data validation directly.

Instead, the regulations and guidances focus on requirements that the data handling systems must meet to ensure data quality and integrity.

Regulations and guidances that do mention clinical data validation, or a part of the process, are listed below.

The general outline for data validation is listed below.

From an ethical perspective, clinical data affect treatment decisions, which affect patient health, and the patient population in question is virtually all of the United States and a significant fraction of the rest of the world.

While the industry expects to leverage a greater range of patient data in clinical trials, companies in 2017 are primarily managing electronic case report form (e CRF) data in their primary electronic data capture (EDC) system.

However, the validation process is complex and dependent on the data captured, business and regulatory concerns, the data management software used, and several other factors, so there are many possible variations and options.

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