Clinical EDC Data Management solutions (CDM) are an essential part of clinical research. Case Report Form (CRF) design and CRF annotation are two of the many CDM procedures that go through a quality check at equal time intervals during a clinical trial. The CDM database check is also a part of these procedures.
Here’s what CDM is all about:
1. EDC Data Management Solutions and CDM tools
There are a lot of computer programs that can help you keep track of your data. These programs come under the broad category of Clinical Data Management Systems (CDMS). It is now crucial to use a CDMS in multi-center studies because of the vast amount of data that requires tracking.
2. Regulations In CDM
CFR 21 Part 11 and EDC Data Management Systems
Some standards and rules in CDM require strict adherence, just like in other parts of clinical research. The pharmaceutical industry relies on electronic data to evaluate medicines. The CDM systems must comply with the Code of Federal Regulations (CFR) 21 CFR Part 11.
Health practitioners and workers who enter, modify or delete electronic records need to prove that their actions were done securely and at the right time. This means validated systems must be used and computer-generated, time-stamped audit trails.
3. CDM Process
The CDM process begins with a review of the protocol from the viewpoint of database design to make sure it is clear and consistent. The CDM staff will determine which data items require collection and how frequently. The database has information about the study’s goals, sites, visits, patients, and intervals, for which CRF layouts stored the entered data.
The CRF used to collect the data would be an electronic version. The investigator will be logging into the CDM system at the site and putting in the data there. A Clinical Research Associate (CRA) would check the data to make sure the CRF entries are correct.
Data validation ensures that data is correct and in line with protocol specifications. Edit check programs look for mistakes in the database.
Examining discrepancies, finding out why, and resolving them are all part of discrepancy management. Discrepancy management helps clean up the data and find enough evidence to support the deviations found in the data.
Medical coding helps identify and correctly classify the medical terms used in the clinical trial. Medical dictionaries found online are helpful for this purpose. The final data validation ensures no discrepancies so that a statistician can check the finalized datasets.
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