Electronic Case Report From (eCRF)

Business Idea

Keeping secrecy and privacy

Keeping privacy during a clinical trial is a must, which might require an extra care in case of a electronic case report form.
Similarly, concers regarding the data safety and integrity are constant fears connected to eCRFs. Being aware of the above facts, we never loose on our strict safety rules and regulations to keep assuring secure handling of our client’s data.
To keeping everything transparent any action (and data-specific change) are logged and stored.

Efficient support of data entry

Qulity depends on the input, so our main focus is on the efficient support of data entry. This support is two-fold: a) system usage is very easy, absolutely self-evident b) data entry is supported with different tools (checks, notifications, auxiliary databases, online guides and human help-desk).

Maximal flexibility in reporting

The way of information retrieval from any data collection system is probably the most important characteristics. In terms of this concept we increased the level of our services to the theoretical maximum: with our pre-build report generation engine ANY information can be retrieved from the database with a maximal felxibility.

Cost-effective implementation

Cost-effectiveness which primarily means implementation of new trials within a reasonably short time is an evergreen business claim. To fulfill this demand we introduced the program driven programming approach. In other words paper CRFs, eCRFs (including the checking conditions) are generated from properly parametetized Excel-sheets.

 

Authentication

The system (including reporting) can only be accessed by pre-defined users with appropriate authorization. Each user has unique password. Electronic signature concept is also implemented besides the passwords. The first, user-specific (unique) password is generated by the sCRF system and is sent to each participating investigator (and other players of the study) automatically. Investigators can change their own password at any time. Forgotten passwords can be replaced by computer-generated passwords, or - in the worst case - by Planimeter’s help-desk password-generation facility. Any type of password-policy can be supported: rules can be set up for the length of password, for the type of acceptable characters, the expiration duration, number of unsuccesful trials.

Reporting

Reporting is a key feature of Planimeter’s e-CRF solution. Basically there are two types of implemented report concepts: pre-defined, that is so-called status reports. Other type of reports can be flexibly parametrise by the users (investigators, monitors, project management, etc.). This solution provide an efficient tool for defining own reporting templates.

FEATURES

  • Fully compliant with FDA 21 CFR part 11
  • application of ANY authentication policy
  • program-aided data entry: several methods to support data entry
  • real time syntactic check of entered data
  • application of pre-defined logical checks
  • automatic query generation extended with manual query generation
  • full audit trail
  • status reporting
  • availability of reporting templates
  • complete advese event managemet
  • internal document management
  • multilingual environment
  • easy data transfer
  • 24 hour service desk (human and answering machine).

 

 Data Input

Conditions and instructions can be defined item by item to support the data-entry process. This support covers the following issues: • declaration of the set of variables, for which missing data is not acceptable, • definition of acceptance range for each variable, • fixing a default value (e.g. year the of the actual visit) for a variable, • specification of the default help-text with an extended explanation regarding the variable, • notification in case of entering data outside of acceptance range, • notification in case of breaking any pre-defined checking condition, • on-line (and downloadable) manual, • help-desk on working days between 9 a.m. and 4 p.m., and automatic answering machine in rest of time.

Complete Query Management

Queries are defined in different documents associated with data quality management procedure. They are defined on one hand by the so called Selv-Evident Correction rules and on the other hand by Data Consistency Condition checks. During the the data entry procedure all pre-defined checking conditions are continuously applied and whenever any of them seems to be hurt, a notification appears on the screen. Queries can be generated manually as well, this opportunity is available for the study monitors. Query management is fully completed in SAS, as some queries might arise during the data review or coding procedures, which data management steps are already taken within SAS-framework.

Our technology makes us possible to prepare a draft eCRF from scratch within not more than 2 weeks including the: Paper CRF, Annotated CRF, Electronic CRF.

Reporting.

Pre-defined, flexibly editable.

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