Lynn clinical trial electronic data acquisition system.
Functional characteristics
EC editor with independent property rights
Through the built-in editing and checking editor, users can write or batch generate corresponding editing and checking programs as needed, check the data input by researchers online in real time, send questions to the system when there are any problems, and allow users to manually send questions.
Support multi-version * * * storage
For complex clinical trials, such as tumor trials, different CRF versions can be used for different visits of the same subject, and the system can automatically identify them without data migration; Different centers can push different versions.
Questioning classified management
Users can use the query classification management function provided by the system to quickly classify queries, including queries published by CRA, queries published by DM and queries published by Medical. The system has the whole process management and traceability function of query opening, clarification and closing, and has the function of automatic query closing.
Support batch data cleaning
Support batch PI signature, batch SDV, batch approval, batch locking form, batch freezing, batch locking account, etc.
Audit trail-audit trail
Keep all audit trails before and after the change to facilitate data traceability, and save the source data such as the changed user, IP, time, before and after the change.
Reporting function
The system supports the export of various commonly used statistical reports in clinical trials, and also supports the generation of some custom reports.
Built-in retrieval of drug generic names
When users input data, they can search similar names in drug names through fuzzy retrieval, and list the functions that data input personnel can choose.
Visit reminder
Built-in static and dynamic call reminders, the static call reminder is set according to the fixed number of days around the fixed call date, and the dynamic call reminder is set according to the variable number of days around the call date.
Iterative process of standardized version of standard
Every iteration of the version, from request, approval, task decomposition, allocation, use case writing, test table submission, testing, BUG discovery, BUG resolution, BUG closure, product release. These operations have corresponding standardized operating procedures.
Product advantage
data encryption
Use https for data transmission, database backup regularly, and role-based authority control (such as data administrator, applicant, auditor, researcher, CRC, etc.). ), database locking and unlocking.
Multiple control types
The system has built-in controls, such as radio, check box, text, text area, date, time and so on. , which can meet the different needs of researchers to input data and verify the validity of the data input by researchers.
Unified access portal
An email account can participate in all projects across multiple bidders at the same time, and can also select and switch projects at the front desk.
MedDRA coding
The system integrates MedDRA coding dictionary, which can automatically code the fields with codes set, and supports the coding of historical synonyms.
SOP specification
The system has specific SOP files from project startup, eCRF construction, editing and checking, pushing production environment and eCRF version change to prevent risks.
Interface with randomization system and researcher system
At present, the domestic exclusive and ZTE Jacky researcher system and MagMinDA clinical trials are randomly grouped &; EDC Company has realized the seamless connection of drug tracking management system.
Support custom approval process
There is a built-in custom data cleaning process, and the order of SDV and review can be set as needed.
The laboratory reference value supports dynamic age setting.
For a long test cycle, the data entry person does not need to change the age, and the built-in algorithm in the system automatically calculates the dynamic age of the subject, and matches the normal range of the laboratory with this age.
SAS file direct export
SAS files can be exported with one key, without the translation of SAS system, which is more convenient for users to view and proofread data.
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