EDC system function
Clinical trial data collection is the core content of drug clinical research. Real, accurate, timely, and standardized data collection can significantly improve the quality of clinical trials and shorten research cycle. In the traditional model, clinical trials mainly rely on paper case report forms (CaseReportForm, CRF) to complete the data collection and management process. Paper-based CRF cannot guarantee the reliability and safety of data, and the data collection and management cycle is long, which slows down the clinical research process.
The EDC system uses an Electronic Case Report Form (ElectronicCaseReportForm) instead of a paper case report form to collect and manage clinical trial data.
Data Entry
The clinical research coordinator (CRC, ClinicalResearchCoordinator) enters the data collected in the original medical records into the EDC system, and other users of the system (researchers, clinical monitors, data The administrator) can see the data update on the system in real time.
Edit check
The EDC system can automatically check the data entered by the CRC through the edit check set when the database is created. Generally speaking, the edit check of EDC system includes system check (SystemCheck) and logic check (EditCheck). System check refers to checking the value of a single data point. For example, the minimum age of entry for a certain item should be greater than 18 years old. If the number in the "age" column is less than 18, the system will automatically pop up the question and prompt that the value should be greater than 18 .Logical inspection refers to the logical inspection between different data points of the EDC system. The logic of the inspection comes from the requirements of the scheme. If "adverse events" is checked with "concomitant medications", but the "combined medications" of this visit is not filled in, the system will pop up a question and prompt to check the filled data.
Different from the system check, the logic check has higher requirements on the system, and a good program structure helps to achieve a more powerful logic check function. If you set up sufficient logical checks when building the patient database, you can save a lot of time for the project team. The relatively weak logic check function is the main gap between the domestic EDC system and the world mainstream EDC system; the logic check function of European and American EDC systems such as MedidataRave, OracleInForm, DataLabs and other systems is relatively mature and complete, and most domestic EDC can only do very simple Logical inspection, but some new domestic EDC systems have shown strong latecomers, and the logical inspection function is close to mainstream EDC systems.
Online communication
The online communication function allows project team members to conduct targeted discussions around the data in the EDC, increasing the convenience of communication. The EDC system using HTML4 network technology can only carry out text communication, and does not support voice dialogue, such as Rave, InForm, etc. The EDC system developed based on the updated HTML5 technology can realize voice dialogue, which has higher communication efficiency and more convenient operation. The domestic system started late, so the EDC system using HTML5 is mainly domestic system, such as ClinFlash.
Permission control
The EDC system must have precise user permission control functions to enable The division of labor for each user complies with GCP or ICH-GCP specifications. These users include PI (signature), CRC (data entry, question and answer, coding), CRA (data verification, questioning), DM (data review, questioning, coding, freezing, lock library), etc. (the above permissions are in actual operation There may be discrepancies, and not all of them).
Operation traces
The EDC system should comply with 21CFRPart11, which is the US federal regulations on electronic records and electronic signatures. The EDC system that complies with the regulations will leave traces for every data modification, update, review, audit, signature, etc., which can be viewed by authorized persons.
Data export
With the activities of the CDISC standardization organization in China, more and more companies are beginning to pay attention to the CDISC standard. CDISC is the Clinical Data Interchange Standards Consortium (Clinical Data Interchange Standards Consortium). Data conforming to the CDISC standard is easy to exchange, integrate and re-dig. The CDISC standard will soon become a mandatory standard for drug declaration data in developed countries or regions such as Europe, America and Japan. CFDA is also vigorously advocating this standard. There is no doubt that CDISC will also become a mandatory requirement of CFDA. Rave, InForm and other systems have passed the CDISCODM certification, and data export conforms to the CDISCODM standard, so there is no need to reprocess the data format; and no domestic system has passed the certification so far, only the ClinFlash system claims that the data export complies with CDISCODM.