Validating electronic source data clinical trials ben chung and yuri tak dating
The pharmaceutical industry has reached a fork in the road.There will be those who will choose to stay where they are in the short term, and there will be those who will embrace the integration of EHR and EDC systems.Those of us in the healthcare trenches, whether physicians, patients, employers, payers or government officials, can easi Iy be forgiven for having more than a dollop of cynicism about the current enthusiasm about the adoption of EMRs.
It is rare for the clinical trials industry to spend time and money on a tedious and labor intensive process when it is not required by the U. The high cost of source data verification (SDV), particularly in large trials, has made it a target of scrutiny over the last decade.
In addition, the positive impact (ie, cost-benefit ratio of SDV) on overall data quality is often questioned.
These data were transferred manually by the site to paper case report forms (CRFs), which were then monitored against source documents by CRAs to basically see how accurately information could be copied from one piece of paper to another.
Sometimes it seems as if we've been discussing electronic medical records (EMRs) forever.
It is used by sites taking part in clinical trials (such as hospitals) to collect data about each trial participant.
All the data on each individual taking part in a clinical trial, including information on adverse events, are held in the case report form.
Monitoring of clinical trials includes several disciplines, stakeholders, and skill sets.
The aim of the present study was to identify database changes and data entry errors to an electronic data capture (EDC) clinical trial database, and to assess the impact of the changes. But that’s exactly what is happening with source data verification.
According to Target Health, this is the first product to be approved using in its pivotal trial, direct data entry of patient data at the time of the clinic visit into an EDC system, with no need for paper records.