Dream EDC is an electronic data capture (EDC) system designed by Landmark Research, which is offered as a software as a service (SaaS) for its clients. Dream EDC is a web-based platform that allows the collection, management, and analysis of clinical trial data in a secure, efficient, and user-friendly manner.
Dream EDC has the following features:
Easy and flexible data entry
Dream EDC enables the users to enter and edit the data using intuitive and interactive forms, which can be customized and validated according to the study protocol and requirements. Dream EDC also supports offline data entry and synchronization, as well as data import and export from various sources and formats.
Real-time data monitoring and quality control
Dream EDC provides the users with real-time access and visibility of the data, as well as various tools and reports to monitor and control the data quality, such as data queries, data audits, data discrepancies, and data locks. Dream EDC also ensures the data security and integrity, as well as compliance with the data standards and regulations.
Advanced data analysis and visualization
Dream EDC allows the users to perform various data analysis and visualization tasks, such as descriptive statistics, inferential statistics, survival analysis, multivariate analysis, and meta-analysis. Dream EDC also offers data integration, data visualization, and data analytics services, to support decision making and knowledge generation.
Dream EDC ensures data security and privacy by using the following measures:
Encryption
Dream EDC encrypts the data at rest and in transit, using the latest encryption standards and algorithms, such as AES-256 and SSL/TLS. Encryption protects the data from unauthorized access, modification, and disclosure.
Authentication
Dream EDC requires the users to authenticate themselves using a username and password, as well as a two-factor authentication (2FA) method, such as a one-time password (OTP) or a biometric verification. Authentication verifies the identity and legitimacy of the users.
Authorization
Dream EDC assigns different roles and permissions to the users, such as investigator, monitor, data manager, and statistician, based on their functions and responsibilities in the clinical trial. Authorization controls the access and actions of the users on the data, according to the principle of least privilege and need to know.
Audit trail
Dream EDC maintains a comprehensive and detailed audit trail of all the data activities, such as data entry, data edit, data query, data audit, and data lock. Audit trail records the who, what, when, where, and why of the data activities, as well as the changes and comments made on the data. Audit trail ensures the data accountability and traceability, as well as compliance with the data regulations and guidelines.
Dream EDC ensures data integrity by using the following measures
Validation
Dream EDC validates the data entered and edited by the users, using various rules and checks, such as range checks, logic checks, consistency checks, and completeness checks. Validation ensures the accuracy, completeness, and consistency of the data, as well as compliance with the data protocol and requirements.
Verification
Dream EDC verifies the data collected and managed by the system, using various methods and procedures, such as source data verification (SDV), data quality review (DQR), and data reconciliation. Verification ensures the reliability, authenticity, and correctness of the data, as well as compliance with the data standards and regulations.
Data standardization
Dream EDC standardizes the data collected and managed by the system, using various formats and conventions, such as the Clinical Data Interchange Standards Consortium (CDISC) standards, the Medical Dictionary for Regulatory Activities (MedDRA) terminology, and the World Health Organization (WHO) Drug Dictionary. Data standardization ensures that the data are uniform and comparable across different sources, systems, and platforms, as well as compliance with the data standards and regulations.
Correction:
Dream EDC corrects the data errors and discrepancies identified and reported by the users or the system, using various tools and processes, such as data queries, data audits, data discrepancies, and data locks. Correction ensures the resolution, documentation, and communication of the data issues, as well as compliance with the data guidelines and best practices.
Dream EDC ensures data consistency by using the following measures:
Consistency checks
Dream EDC performs consistency checks on the data entered and edited by the users, using various rules and logic, such as cross-form checks, cross-visit checks, and cross-study checks. Consistency checks ensure that the data are coherent and compatible across different forms, visits, and studies, as well as compliance with the data protocol and requirements.
Data harmonization
Dream EDC harmonizes the data from various sources and systems, using various methods and techniques, such as data mapping, data transformation, and data integration. Data harmonization ensures that the data are aligned and integrated across different domains, phases, and regions, as well as compliance with the data guidelines and best practices.
Dream EDC ensures data transparency by using the following measure:
Data sharing and dissemination
Dream EDC enables the users to share and disseminate the data with the relevant stakeholders, such as the sponsors, the investigators, the ethics committees, the regulatory authorities, the public, and the scientific community. Data sharing and dissemination ensures that the data are accessible and available for review, verification, replication, and reuse, as well as compliance with the data transparency and openness principles and policies.