Principles of Clinical Data Management.pptx

Principles of Data Management

1. PRINCIPLES OF DATA MANAGEMENT

2. DATA INTEGRITY Ensures that the required data is captured ,integrated and consolidated so that it can be used for all intended purposes. The data integrity pertains to the chain of custody of data,in other words trace the reported data back to its source. The reconstruction of the process from the reported data back to the source data must be possible through auditing or inspection and should be easy and transparent as possible.

3. DATA QUALITY Ensures that data is continuously profiled for errors and is run through a data pipeline for data quality checking. The data quality pertains to the suitability and fit of the data collected for the purpose of the study. Accuracy and authentically of data helps achieve quality. WHAT IS DATA :- Clinical trail data originates from the patient and healthy volunteers who participate in studies. Raw data are collected between the time of first participant enrolment and study completion.

4. SOURCE DOCUMENTS Source means originality. Source documents are original documents,data or records that are created during a clinical study trail. Source documents are essential documents that are required by regulatory and GCP guidelines. The purpose of source documents is to reconstruct the trail and to produce quality data. Source documentation is the record to the before, during & after the trail. It is the complete medical record of the subject as the refrence to the trail investigators at any point of time. It forms a strong trail that gets transcribed into an eCRF which ultimately transferred into a clinical study report.