From Pen And Paper To Cdisc Standards In Clinical Trials

In recent years, pharmaceutical companies have made great strides in the area of clinical trial data management. However, some companies have yet to implement adequate CDISC standards  to meet regulatory requirements. Consequently, trials are conducted that exceed the minimum standard of care. This often leads to promising  outcomes of clinical trials, including both short-term and long-term results and findings.

Objectives And Outcomes From Clinical Trials

The primary objective of the CPhA guidelines was to establish a uniform definition for measuring clinical trial data risk and to establish a single method for controlling and reporting adverse event severity. Since then, several other specifications have been added to the suite of CDISC standards. These additional capabilities enable researchers to report and control multiple aspects of clinical trials. These improvements are described below:

Both pre-and post-marketing phase clinical trials should be conducted under the most appropriate regulatory CDISC standards in the industry. Thus, both data submission and reporting should be performed according to recognized guidelines for the respective field. Accordingly, both types of the activity should be managed by independent entities that have been accredited by the Joint Review Committee on Data Standardization (JPADCC). To help the independent entities comply with the JPADCC standards, the companies should submit data standardization to the regulatory reviewers.

Clinical Research Documentation Management

The information collection and submission guidelines stipulate that clinical research documents must be reliable and accurate. Furthermore, the documents must be comprehensive, well-organized, easy to read, and accurate. In addition to these requirements, data standards also address the importance of maintaining quality and avoiding unnecessary duplication. In order for clinical research records to meet the minimum quality standards, they must be appropriately organized. Additionally, documentation should be accurate and consistent so that investigators can determine whether a patient’s data collection is reliable. The JPADCC also stressed that data standards must be consistently applied to clinical trials both at the pre-and post-marketing phases.

How Data Is Handled

While all the aspects of the data collection and submission are very important, e.g., accurate data collection and submission or reliable clinical data, researchers should also consider the timeliness of their submissions. At present, there are some issues that need to be addressed in order to make the entire process easier, such as potential conflicts of interest. One example is when one of the parties is not subject to any regulatory requirement, therefore the other party is needed to follow these standards. Another issue is the potential abuse of the procedure, which may take place when there is confusion or inconsistency between the parties. This may occur due to lack of uniform standards in the electronic data standards. To avoid potential problems, it is recommended that the clinical research entity should establish an internal electronic data standard.

How Can CDISC  Standards Be Used In Future?

The standards also provide guidance on the choice of the appropriate data analysis software. The developers of the software should ensure that it is compliant with the CDD standards. Also, when data collection is part of the trial protocol, adherence to the required protocols is necessary. This helps in ensuring that the data collection and analysis procedures conform to the regulations of the respective authorities. The use of the right tools and software ensures reliability of the data sets submitted to the FDA.