Stages of Implementation of the OnlineCRF Electronic Data Capture System
The OnlineCRF system is actively used as an internal tool for collecting and ensuring the quality of clinical data. Additionally, upon client request, the system is configured to meet the specific requirements of a clinical protocol and then handed over for project management. In such cases, Pharmaxi acts as a technical contractor, ensuring that the system remains fully operational throughout the project.
Assessment of Applicability for the Project
At the initial stage, we carefully evaluate the project’s characteristics and provide recommendations on the most suitable data capture tool. For small local projects—often conducted by local Ukrainian companies or Western company affiliates—the cumbersome procedure of deploying, configuring, and validating an electronic system may not be justified. In these cases, alternative data collection methods might be more appropriate.
Determination of Basic Operational Parameters
Once it is decided that using OnlineCRF is beneficial, we determine the system’s baseline parameters. This includes identifying the number of users who will work within the system, defining their roles, and establishing the necessary permissions and restrictions. We also ascertain the number of patient visits, the required number of forms, and the overall duration for which the system will be used in the project. Additionally, we estimate the approximate number of eCRF forms to be implemented and specify the types of fields required for that particular study.
Cost Estimation for Deployment and Support
Based on the established project parameters, we calculate the cost for the configuration, deployment, and validation of the system. Our specialists can also perform remote monitoring and data quality assessments. During this phase, we define the list of tasks that Pharmaxi will undertake. Configuration and validation are carried out by our in-house team and cannot be delegated externally. This process results in a definitive cost for both the system’s deployment and ongoing support.
System Deployment and Configuration
In this stage, we prepare a complete set of documentation that outlines the requirements for the future system. This documentation explicitly describes the technical and functional specifications mandated by the clinical protocol. Following this, technical work is performed to configure the OnlineCRF system according to the documented requirements, ensuring a precise setup tailored to the study’s needs.
Validation and Verification
Aligned with GCDMP standards and our Standard Operating Procedures (SOP-DM-01 to SOP-DM-17), the system undergoes a multi-step validation and verification process. This rigorous testing confirms that the system operates in full compliance with the project documentation and meets all specified requirements, ensuring that it is fully ready for use in the clinical study.
Pilot Run and Training Phase
Before full-scale deployment, the system is launched in a pilot or introductory mode. In this phase, investigators can enter test data and receive training on how to use the system effectively. This trial period is crucial to reduce user errors when real clinical data is eventually recorded, thereby enhancing overall data quality.
Transition to Real Clinical Data Collection
After successful completion of the pilot phase, investigators begin entering actual patient data into the OnlineCRF system. At this stage, a dedicated support staff member is assigned to answer questions and resolve any issues that may arise during data collection, ensuring a smooth transition from testing to real-world application.
Data Cleaning and Quality Assurance
Pharmaxi employs advanced algorithms to identify potentially unreliable data. These algorithms generate clarifying queries, prompting corrections where needed. Additionally, the system enables remote medical monitoring to verify data quality and ensure strict adherence to the clinical protocol, thereby enhancing the overall integrity of the study data.
Soft Lock of the Database
As the study nears completion, eCRFs are thoroughly reviewed for accuracy and proper digital signature by the Principal Investigator. Once verified, the system initiates a soft lock on the database, which prevents further editing by investigators while still allowing final quality checks.
Final Database Lock
After the final review, the system completely locks the database, restricting access for all investigators. This final lock stage ensures that no further changes can be made, and the data can then be safely exported for statistical analysis and reporting of study outcomes.
If you have any questions regarding the features and capabilities of the OnlineCRF system, please call +48 739-108-217 or fill out our contact form. We also offer a free 30-minute consultation on any clinical research-related topics.
