In this video I will be discussing with you all the concept of clinical data management. So clinical data management plays an essential role in the data collection phase of clinical research. The process of collecting and managing research data is done in accordance with regulatory standards. To obtain quality information that is complete and error free. The goal is to gather as much as data for analysis as possible. The field of clinical data management has come about due to demands from both the pharmaceutical industry and the regulatory authorities to maintain the integrity of the data.

The CDN or the clinical data management process starts at the very beginning of a clinical trial. Even before the study protocol is finalized. The CDF team or the clinical data management team designs a case report from CRF and defines the data fields to be utilized CRS specify the type of data to be collected the units of measurement to the USD and CRF completion guidelines variables are notated using coded terms or data management plan is then developed as a guide, including a description of the trial CDM activities. Databases are built to support CDM tasks with corresponding compliance tools. testing is done before using the plan with actual clinical trial data CFR tracking data and fee validation, discrepancy management, medical coding and database locking. These are the different clinical data management activities.

So therefore what is clinical data management clinical data management is the process of handling data from clinical trials. The inherent goal of any clinical data management system is to produce and maintain quality data. Clinical Data Management is a critical process in clinical research which leads to generation of high quality, reliable and statistically sound data from clinical trials clinical data management and Connection integration and availability of data at appropriate quality and cost. Now there are certain steps in the process of clinical data management what are the first is the store source data are generated. Common examples of source data are clinical sites, medical records, laboratory results and patient IDs. Like the results, the tests that are done in the labs, the results of those tests, the different medical records of different patients and the patient IDs.

These are the sole status if paper case report forms that is CRF are being used. The clinical site records are transcribed onto the CRS data from the CRS as well as the other source data entered into the clinical trial database. Next, electronic CRS allow data to be entered directly into the database from source documents. Data from paper CRS are often entered twice and we can reconcile in order to reduce the error rate. The data are checks to complete To see quality and completeness and problems are resolved. This often involves queries to the clinical site.

The database is locked when the data are considered finding the data reformatted for reporting in analysis tables, listings and figures are also generated. The data analyzed in the analysis results are reported. When significant results are found. This step may result in the generation of additional tables, listings or figures. The results are integrated into high level documentation such as investigators, brushes, and clinical study reports. The database and other study data are achieved.

So this is the concept of your clinical data management. In my next video, I will be discussing about the different types of clinical data and what is clinical data. So for now, let me end this video over here. Thank you. Good bye. See you all for the next video.