Validating electronic source data in clinical trials Sex dating and xxx adult friends free sex and sex chat with local adult
Phase I trials are even less expensive at nearly ,700 per patient.
Amount of volunteer patients per phase is usually: 20 to 80 for Phase I, 20 to 300 for Phase II and 300 to 3000 for Phase III, which totals to roughly ,784,000 per average trial.
Clinical data is one of the most valuable assets to a pharmaceutical company.
Data is central to the whole clinical development process.
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 .
date, site, name of the monitor etc.) Even though electronic data management techniques allow to prevent a lot of "dirty data" during data collection, there are much more actual processes of data cleansing.
The cost per patient of Phase 3 clinical studies of new pharmaceuticals exceeds ,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 ,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 less published information exists on methods of quantifying data quality".