GCDMP: 8. EDC Study Implementation and Start-Up (2021)

Web-based EDC

Utilized for designing, testing, and implementing workflow in clinical studies

Clinical Data Management (CDM) professionals

Responsible for EDC application implementation in clinical studies

CRF design considerations

Focused on graphical layout, visual cues, and writing instrument rules

Clinical Database Management System (CDMS)

Partially automated data entry workflow in early data management

Web-based EDC systems

Shifted data entry work to investigational sites with limited data management functionality

EDC system selection

Recommendations provided in a separate chapter for study conduct and closeout

E6(R2) Good Clinical Practice

Regulatory guidance emphasizing qualifications, data handling, and quality control in trials

EDC system benefits

Includes automation, connectivity, decision support, and data mining for clinical research

Study database cycle time

Average days for building, releasing, and locking a study database

Quality assurance and control

Systems and SOPs ensuring compliance with protocol, GCP, and regulatory requirements

Workflow and data flow implementation

Key for realizing value from EDC functionality in clinical studies

EDC

Electronic Data Capture facilitates workflow and data flow for clinical studies.

Validation

Validation of systems based on risk assessment considering intended use and system potential.

SOPs

Standard Operating Procedures for system setup, maintenance, and data handling.

Data Attribution

Explanation of how source data is obtained, managed, and recorded electronically.

System Documentation

Identification of software and hardware used for clinical data management.

Training

Education and training necessary for personnel using computerized systems.

Data Integrity

Ensuring data accuracy, completeness, and meaning throughout its lifecycle.

Traceability

Ability to trace user-defined parameters back to raw data in data processing.

Audit Trails

Records that reconstruct all data processing activities for review and validation.

Electronic Signatures

Digital signatures used for validation and linking to electronic records.

Raw Data

Data that allows full reconstruction of activities and observations.

Change Control

Formal process for reviewing and implementing proposed changes in computerized systems.

Software Validation

Process ensuring software meets intended use requirements and is validated for its purpose.

Risk Assessment

Evaluation of system risks to determine validation and data integrity controls.

Data Processing

Activities involving the transmission and handling of data in clinical trials.

Regulated User

Individual subject to regulations ensuring system quality

Quality Management System

Framework ensuring system development meets standards

Data Security

Protection of data through backups and access control

Critical Business Processes

Key operations safeguarded against damage

GxP Assessment

Evaluation to determine if system is GxP regulated

Audit Trail

Record of GMP-relevant changes and deletions

Controlled Changes

System modifications following defined procedures

Patient Safety Assessment

Evaluation of system impact on patient safety

Electronic Health Record (EHR) Data

Information used in clinical investigations

Data Sources Documentation

Recording and retaining sources of data

Authorized Data Originator

Individual or system associated with data elements

Data Quality Checks

Electronic prompts to minimize errors in data entry

Workflow Control

Defining and enforcing data collection processes

Minimum Standards

Baseline requirements for study implementation using EDC systems

Standard Operating Procedures (SOPs)

Established guidelines for system operation

Cross-functional Teams

Teams involving various departments for system development

Data Discrepancies Correction

Processes to identify and rectify data errors early

Safety Data Processing

Handling and routing safety data within the system

eCRF design

Involves layout, data elements, and organization into forms and visits.

Dynamic behavior

EDC system response to user input, automating workflow and data flow.

Data standards

Recommended for ensuring data consistency and compatibility.

EDC system production

Should precede patient enrollment for smooth operations.

Automation

Used to guide data entry and actions based on entered data.

Human-centered design

Involves user testing and iterative involvement for system optimization.

Source Document Verification (SDV)

Field-level verification supporting error rate estimation.

Workflow optimization

Requires experience and human-centered design principles for efficiency.

Data collection forms

May be provided in local languages to aid user understanding.

Data entry guidelines

Comprehensive help for accurate data input and system understanding.

Data flow automation

Facilitated by EDC systems to optimize study conduct.

Data manager

Requires understanding of workflow, data flow, and system functionality.

EDC study implementation

Involves re-engineering processes and improving decision-making.

Study build

Begins with static aspects of eCRFs and involves data grouping.

Value from EDC

Requires process re-engineering and decision-making improvement.

Data value optimization

Achieved through automation and practical workflow constraints.

EDC system training

Broad and essential due to system complexity and user roles.

Data storage structure

Impacted by data definition, grouping, and layout in EDC systems.

User input response

Varies system behavior and workflow based on user actions.

Field-level SDV

Leverages EDC for error rate estimation and data verification.

EDC system constraints

Should be carefully designed and user-tested to avoid issues.

EDC system functionality

Includes dynamic behavior, automation, and workflow guidance.

Value erosion

Occurs when automation fails to handle exceptions gracefully.

EDC system setup

Often referred to as 'building a study' due to added value for sites.

Electronic Data Capture (EDC)

Mainstay of form-based data collection in clinical studies

Paper CRFs

Historical method for data collection in clinical studies

eCRF

Electronic Case Report Form for data recording

User Acceptance Testing (UAT)

Testing ensuring system readiness before deployment