The Electronic Data Capture (EDC) system should ideally meet all the requirements of a clinical trial. This is critical to the quality of data collection and project success.
In each study, we distinguish three main blocks of requirements. All of these should be taken into account when configuring the system. Only in this case, will the system be ideal for your clinical research.
The EDC system has to meet the following regulatory requirements:
The EDC system for clinical trials must meet all of the above standards. It also must have documents of compliance. This is critical for proper data collection in accordance with industry regulations. And compliance documents will be needed in the case of regulatory audits.
The EDC system must comply with the requirements of the Clinical Study Protocol. During configuration, the values of the following parameters should be taken into account:
If the system is not clearly configured to these points and does not comply with the Protocol, there is a risk of collecting irrelevant data or lacking data that is needed for statistical processing.
The EDC system should be convenient for researchers to use. For convenience, many functions can be implemented, for example:
These and other factors are essential for the rapid and quality input of data by the researcher. As researchers are often limited in time, the EDC system should have a set of various supporting functions that facilitate their work.
Our goal is building long-term relationships with clients and running excellent projects. Therefore, we offer free 30-minutes consultations on any questions related to clinical trials and clinical data management. We will be happy to provide a practical advice and clarify some elements of your clinical trials.
Please provide us with the basic information and we will get back to you within two business hours.