Clinical Data Management

As the number of patients flocking down the hospital doors is on the way up

, due to a myriad of reasons, the hospital has to ensure that it is capable of handling all of its patients. The hospital should be fully capable of taking care of all its patients and at the same time be able to record their movements. In order to help with this, Clinical data management was introduced. In the olden days, there wasnt anything of this sort, but now thanks to the advent of technology there is something that helps the hospital to keep tabs on their patients. Clinical data management encompasses the entry, verification, validation and quality control of data gathered over the course of a clinical trial.

When it comes to Clinical data management, it is broadly divided into two different systems, namely, paper-based and electronic data capturing systems. Now let us begin with paper based systems. It is a system in which case report forms are manually filled at site and mailed to the company for which trial is being performed. The data on forms is transferred through to data entry. The most popular method being double data entry where two different data entry operators enter the data in the system independently and both the entries are compared by the system. In case the entry of a value conflicts, system alerts and verification can be done manually. After which, the data in system is transferred for data validation. During validation, the data clarification from sites are done through paper forms, which are printed with the problem description and sent to the investigator site and the site responds by answering on forms and mailing them back.

One person who plays a pivotal role in this is the clinical data manager, who is responsible for setting up and conducting a clinical trial. The data which is collected during a clinical trial forms the basis for subsequent safety and efficient analysis which in turn drives the decision making on to the product development in the pharmaceutical industry. The clinical data manager is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol. Once subject enrollment begins, he ensures that data is collected, validated, complete and consistent. The clinical data manager acts as a go-between with other data providers and ensures that such data is transmitted securely and is consistent with other data collected in the clinical trial. At the completion of the clinical trial, the clinical data manager ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final and the clinical data manager transfers data for statistical analysis.

The second type of system that is used is the electronic data capturing system. In this, the investigators directly upload the data on to the system and the data can then be viewed by the data validation staff. Once the data is uploaded, the data validation team can send the electronic alerts to sites if there are any problems. One benefit of such systems is the fact that they eliminate paper usage during the process of Clinical data management. Once the data have been screened for typographical errors, the data can be validated to check for logical errors. An example is a check of the subject's age to ensure that they are within the inclusion criteria for the study. These errors are raised for review to determine if there are errors in the data or if a clarification from the investigator is required.

Another function that is performed is the coding of data. At present, the coding is generally centered on two areas adverse event terms and medication names. With the variance on the number of references that can be made for adverse event terms or medication names, standard dictionaries of these terms can be loaded into the system. Items that do not match can be flagged for further checking. Some systems allow for the storage of synonyms to allow the system to match common abbreviations and map them to the correct term. As an example, ASA (acetylsalicylic acid) could be mapped to aspirin, a common notation.

At the end of the clinical trial the data set in the system is extracted and provided to statisticians for further analysis. The analyzed data are compiled into clinical study report and sent to the regulatory authorities for approval. The authorities go through the data from the clinical trials and then publish the results and forward them onto the drug manufacturing companies, as it helps them with the production of certain medications, which are high on demand in the market.

Most of the drug manufacturing companies use web-based Clinical data management systems for capturing, managing and reporting clinical data. This not only results in faster and more efficient data capture, but also speeds up the process of drug development. In such systems studies can be set up for each drug trial and in-built edit checks help in eradicating erroneous data. The system can also be connected to other external systems and as a result has the potential to take Clinical data management to the next level.

by: microtheraps

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