Mythos CDMS is a clinical data management system developed by AdWare. The Mythos CDMS streamlines all processes from eCRF planning, trial execution and monitoring, data cleaning and structured export for statistical analysis without requiring special IT knowledge.
Our system and all operating procedures are FDA 21 CFR Part 11 and GCP compliant, validated and audited regularly by our sponsors and the Hungarian National Pharmaceutical Institute. The system goes through regular penetration testings as well.
The Mythos uses Oracle database to provide reliable, secure and traceable data management. It provides complete Audit trail functions and records all information about data changes: who, what, when, why has changed the data and what is the new value. The system assures that electronic records generated and maintained are “trustworthy, reliable, and generally equivalent to paper records and handwritten signatures”.
Mythos CDMS offers highly customizable workflows and role-based access control lists and can be integrated into the sponsors’ QA processes.
The data entry screen visualizes the CRF in a user-friendly way and with showing additional information the clarity of recorded data can be increased that speed up the closing and evaluation process. Complex dependency management and real-time edit checks can be defined declaratively between form fields and activities (eg. visits) which needs no special IT or programming knowledge. These features provide:
- completion guide
- real-time edit checks with min/max ranges, and scripted validators
- immediate and automatic data monitoring
- query (data cleaning form) management
- dynamic fields controlled by measurements and findings
- value-attached notes
- Part 11 and GCP compliant audit trail
- data entry progress tracking
- ad-hoc and scheduled/automated reporting
- email notification triggers with PDF attachments
- calculated values
1. eCRF (electronic data entry)
- no need for additional software installation – only an Internet connection and a browser are needed to collect clinical data in compliance with regulations.
- Secure data transfer and storage – eCRF data are stored solely in the Mythos Oracle® database, while on the users’ side there is not even a temporary storage. Data are transferred to the database by saving the actual eCRF page. The system uses secure SSL connection (applying data encryption) for data transfer.
- Immediate and automatic data monitoring – the system is programmed for automatic data check which is able to detect data not meeting the previously set requirements (extreme or logically impossible values, derivative data like BMI, fields compulsory to fill in, chronological order, violation of the time-window, violation of protocol, etc.).
2. Paper-based CRF
In case of traditional paper-based data recording, it is possible to establish closed network data management systems which do not have access to any external network / Internet.
Each field which can be determined at the time of the creation of the query is filled in automatically and cannot be changed. Query is identified by a unique number – query ID – which cannot be changed and are generated automatically. The only thing that the Data Entry person has to do is to compose the question. The Data Manager, having the required rights, is able to edit the answer field, change the status and result fields save them in .pdf format and if necessary print them out.
To ensure the reliability and correctness of the data entry many trials require Independent double data entry. Every member of the Mythos family is able to provide independent double data entry. The result is two database tables which can be compared and checked by a third party, using the system compare function. During the comparison process, the system detects the differences and lists them by patients, showing both data values and provides the possibility for correction. The possible corrections are recorded by the audit trail function which cannot be switched off. The correction takes place after discussion with the two data entry persons. A new – the third – database table can be created at any time which contains the data identical in both databases. The comparison can be done at any time, so the divergences can be corrected continuously and the final clear database will be available right at the end of the data entry process.
The Mythos Admin is a local application running on the server and it makes possible to manage the studies and users. Moreover, it provides a filter function for statistical data of queries, audit trail and errors. These all can be listed and saved in .pdf format and also can be printed out.
- Study management Back-up or Restore studies, edit study descriptions) Study data can easily be saved into a separate file protected by individual password. The data manager having the required rights can reload all these data.
- Admin (Users) Creating new users, managing their personal data, assigning them to particular studies with given rights.
- Roles Customizable role-based authorization and ACLs.
- Query control Filtering already existing queries, ordering them into lists, saving them into .pdf format and printing them out as it is necessary
- Error statistics According to the data recorded by the audit trail, the system counts and shows the amount of data entered (by users), moreover it indicates the modifications done on them.
- Audit trail Filtering the recorded entries and ordering them into lists, saving them into .pdf format and printing them out.