Features

Clinic EDC is a large framework and provides rich functionality to build a clinical trial system that will ensure, even in complex settings, the collection and management highly-available research-grade data.

  • modules for each of the core components of a typical longitudinal RCT

  • easy to configure field level encryption for sensitive data

  • randomization online and in realtime

  • allocates unique study identifiers and maintains a master register

  • versioned consent management linked to the data collection periods per participant

  • field-level encryption for sensitive data

  • user account management with role-based permission levels

  • adaptive data collection schedules and collection workflows

    • named schedules linked to consent

    • named collection timepoints with required and optional CRFs and specimen requisitions

    • PRN and other timepoint independent data forms

    • lower and upper window period constraints per timepoint

    • fully customizable collection rules (metadata-rules)

  • participant apppointments generated based on the randomization arm and “visit schedule”

  • distinction between scheduled and unscheduled timepoints/appointments/visits

  • study status management

    • clear on-study off-study status management

    • study status and the consent period is aligned to the data collection add/change period

  • default and custom embedded skip logic and inter- and intra-form validation checks – access any part of the dataset to validate data entry

  • structured adverse event document workflow

  • configurable alerts for adverse events and other critical events

  • secure password protected PDF generation of adverse events and death reports

  • realtime reports and online quality assurance tools

  • realtime normal range and DIADS grading assessments for recorded labs linked to adverse event notifications

  • full snap-shot audit trail of created, modified and deleted data

  • every record tracks created and modified values for user, date, software version, locale, host, and device

  • pharmacy module for chain-of-custody management of investigational study medication for IMP-type trials

  • specimen chain-of-custody management

  • label printing with barcodes for specimens and pharmacy IMP

  • adheres to Good Clinical Practice Guidelines (based on ICH guidelines)

  • GDPR, UK GDPR, South Africa POPIA compliant (assuming deployment recommendations followed)