Projection® Electronic Data Capture

EDC vs IDC (Intuitive Data Capture)

Projection® EDC is a fully web-based, state-of-the-art data capture platform. It is incredibly easy to use, requires no installation (thin client) and will operate anywhere that has an Internet connection available.

As Projection® EDC is so user friendly, it require very little training. Data are organized like with paper CRFs: patients are represented by a stack of CRFs, with each patient CRF containing pages organized by visit.

Data quality

Projection® EDC combines simplicity and quality. Data are entered in fields (number, date, string, upper case, limited selection by list boxes or drop down menus).

All data entered can be controlled in real time and tracked. Entries can be checked from zero to three times depending on target data quality:

  • level 1: interactive, automated controls: usually non blocking warnings.
  • level 2: monitoring. CRAs can query the investigator and suggest solutions. Monitoring queries are accessible directly from the CRF and are linked to the original data in or outside context.
  • level 3: batch controls (data management). Investigators can handle data management queries in the same manner as monitoring queries.

Each field is associated with a "specify kind of missing value" selector used to select whether data are:

  • Not applicable,
  • Not available,
  • Unknown.
The system checks for empty fields and generates a warning message if a field stays empty.

Integrated monitoring

Projection® EDC also provides integrated monitoring functionalities:

  • manual queries by CRAs,
  • status follow-up:
    • pages / data to control,
    • pages / data controlled with or without queries,
    • pages signed by investigator,
  • follow-up of answered queries: page / data to re-control after modification by investigator,
  • management of protocol deviations,
  • management of SDV report,
  • etc.

Reporting capabilities, printing capabilities, alert capabilities

Projection® EDC includes standard and specific reports that are accessible from a menu or can be pushed by email. Some are triggered by specific events (new patient, randomization, Serious Adverse Event (SAE), etc.).

  • Patient CRFs can be printed out or generated in PDF format.
  • Data can be exported in CSV format.

Alerts can be triggered by specific events and can be send by email, fax, text message, etc.

Alerts and E2B export ensure optimal SAE submission to the authorities and timely reporting.

Security

Projection® EDC is fully secured. All users need a logon ID to connect to the system and user rights vary with their particular profile. For instance, users may have varying rights for patient data: read, write, ask queries, and may have access to only a certain number of patients, e.g. a particular site or country.

Interface

Projection® EDC can be linked to external clinical trial systems such as:

  • Interactive Web Randomization Systems (IWRS) or Interactive Voice Randomization Systems (IVRS),
  • pharmacovigilance systems (through E2B export),
  • Clinical Trial Management Systems (CTMS),
  • EDM,
  • etc.

Multi-lingual interface

Projection® EDC can be set up in English or French, and patient CRFs can be viewed by clinicians in their local language.

Data management

The Projection® system is of great help to the data manager. In just one application (the Projection® Designer), it provides:

  • a CRF design tool,
  • a tool to program controls,
  • a tool to set up export to SAS software.

It generates a range of reports that can be included in the Data Handling Manual, including:

  • data structure with tables, panels, description of variables and code lists,
  • the annotated CRF.
Projection® EDC can be connected to existing control programs (e.g. written in SAS) by queries loading.

References

World wide studies.

Regulatory compliance

Projection® EDC is fully compliant with 21CFR Part 11. All data transmissions are encrypted through an SSL connection and all actions are monitored and logged to provide a full audit trail.
Projection® EDC includes electronic signature.

All the modules in the Projection® System have been fully validated.

Optional modules

Projection® EDC comes with a range of useful optional modules:

  • IWRS module: randomization capabilities,
  • Drug management module: management of drug supplies and logistics,
  • eTMF module: site documents management,
  • eLearning: clinician training,
  • etc.

Arone's services

Arone can provide services around the eCRF:


Technical requirements

Projection® EDC is supported by Windows and Mac OS and runs smoothly on the most popular web browsers: Microsoft Internet Explorer, Mozilla Firefox, Apple Safari, Opera, Google Chrome, etc.