Validating electronic source data in clinical trials

Data reconciliation, which take place at the end of clinical trial and refers to a process that compares two sets of records to make sure they are in agreement.This includes matching the source and reflecting an accurate, valid value.

The cost per patient of Phase 3 clinical studies of new pharmaceuticals exceeds $26,000, on average, according to benchmarking report, published by business intelligence firm.

Phase 2 trials are comparatively cheaper, with the average per-patient cost falling just over $19,300 per patient.

Queries that arise during the reconciliation of the data should be handled in the same manner in which clinical queries are handled Standard operating procedures (SOP) and quality analysis should be a part of every study in which the company invests money to collect end-points, be they traditional or pharmacoeconomic end-points.

Most databases include a certain amount of exceptional values.

Even though trial designs are often unique and require different handling depending on the particular trial, data manipulation methodologies chare a common set of tasks to be performed on certain stages (Figure I).

Every stage involves certain data cleaning and validation procedures to ensure data consistency and accuracy (Table I). Most common errors include: typographical errors, copying errors, coding errors and range error .

Pyle in his "Data Preparation for Data Mining" is refering to "outliers" as: "single, or very low frequency, occurrence of the value of a variable that is far away from the bulk of the values of the variable".

In fact, determination of outliers depends on purpose of analysis.

Statistical societies recommend that description of data cleaning be a standard part of reporting statistical methods.

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