What Is a Clinical Data Management System?

EDC system is Electronic Data Capture System, which is directly translated into electronic data capture system, which is a platform software suitable for clinical trial data collection and transmission. With the advancement of technology, more and more data management functions have been added to the EDC system. The mainstream EDC system not only has multiple forms of data collection functions, but also has strong data query functions; it also includes excellent communication between users. The plan enables each user of the same project to communicate effectively around the data in the EDC system. The EDC system has been widely used in clinical trials in developed countries such as Europe and the United States because of its significant advantages, to replace the traditional paper case report form. ^[1] Domestic EDC system is still in its infancy. The utilization rate of EDC system in clinical trials is not high, and the high-end market is occupied by European and American software manufacturers. The domestic system is still hovering in the low-end market; this market structure needs to be more excellent System to break. ^[2]

EDC system

(Clinical trial electronic data acquisition system / data management system)

EDC system is Electronic Data Capture System, which is directly translated into electronic data capture system, which is a platform software suitable for clinical trial data collection and transmission. With the advancement of technology, more and more data management functions have been added to the EDC system. The mainstream EDC system not only has multiple forms of data collection functions, but also has strong data query functions; it also includes excellent communication between users. The plan enables each user of the same project to communicate effectively around the data in the EDC system. The EDC system has been widely used in clinical trials in developed countries such as Europe and the United States because of its significant advantages, to replace the traditional paper case report form. ^[1]

The collection of clinical trial data is the core content of clinical drug research.

Paper CRF Workflow

Real, accurate, timely, and standardized data collection can significantly improve the quality of clinical trials and shorten the research cycle. In the traditional model, clinical trials mainly rely on paper Case Report Forms (CRFs) to complete the data collection and management process. Paper CRF cannot guarantee the reliability and security of data, and the data collection and management cycle is long, which slows down the clinical research process. ^[2]

The EDC system uses an Electronic Case Report Form instead of a paper case report form to collect and manage clinical trial data.

EDC system data entry

The clinical coordinator (CRC, Clinical Research Coordinator) records the data collected in the original medical records into the EDC system, and other users of the system (researchers, clinical monitors, data managers) can see the data updates on the system in real time.

EDC System Editor Check

The EDC system can automatically check the data entered in the CRC through the editing check set when the database is established. Generally speaking, the edit check of an EDC system includes a system check (System Check) and a logic check (Edit Check). The system check is to check the value of a single data point. For example, the minimum age of an item in the group should be greater than 18 years old. If the number entered in the "Age" column is less than 18, the system will automatically jump out of doubt and prompt that the value should be greater than 18 Logic check refers to the logical check between different data points of the EDC system. The logic of the check comes from the requirements of the solution. For example, if Concomitant medication is selected at the Adverse Event and the Combined medication at this visit is not filled in, the system will jump out of doubt 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 setting up the patient database, you can save a lot of time for the project team. The weak logic check function is the main gap between the domestic EDC system and the world's mainstream EDC system; the European and American EDC systems such as Medidata Rave, Oracle InForm, DataLabs and other systems have relatively mature and perfect logic check functions, while most domestic EDCs can only do very Simple logic check, but some new domestic EDC systems have shown strong late power, and the logic check function is close to the mainstream EDC system. ^[3]

EDC system 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 adopting HTML4 network technology can only perform text communication, and does not support voice dialogues, such as Rave, InForm, etc. The EDC system developed based on the updated HTML5 technology can realize voice dialogues, with higher communication efficiency and more convenient operations. Domestic systems started late, so EDC systems using HTML5 are mainly domestic systems, such as ClinFlash.

EDC system authority control

The EDC system must have precise user rights control functions to enable each user's division of labor to comply with GCP or ICH-GCP specifications. These users include PI (Signature), CRC (Data Entry, Question Answering, Encoding), CRA (Data Verification, Questioning), DM (Data Audit, Questioning, Encoding, Freezing, Locking), etc. May vary, and not all).

EDC system operation traces

EDC systems should comply with 21 CFR Part 11, US federal regulations regarding electronic records and electronic signatures. The EDC system that complies with this regulation leaves every trace of data modification, update, audit, audit, signature, etc., and can be viewed by authorized persons. ^[4]

EDC system data export

With the activities of the CDISC standardization organization in China, more and more enterprises have begun to pay attention to the CDISC standard. CDISC is clinical

CDISC ODM Standard Certification

The Data Exchange Standards Consortium (Clinical Data Interchange Standards Consortium), CDISC-compliant data is easy to exchange, integrate, and dig again. The CDISC standard is about to become a mandatory standard for drug declaration data in developed countries or regions such as Europe, the United States and Japan ^[5-7] . CFDA is also vigorously advocating this standard. There is no doubt that CDISC will also become a mandatory requirement of CFDA. Currently, Rave, InForm and other systems have passed the CDISC ODM certification, and the data export conforms to the CDISC ODM standard, so there is no need to re-process the data format. No domestic system has yet passed this certification ^[8] . Only the ClinFlash system claims that the data export conforms to CDISC ODM. ^[4]