OnlineCRF is a system which is configured by our team and allows you to collect clinical data and manage data collection activities.
We have created an electronic data capture system and other procedures to make a system configuration simpler from the customer’s point of view. You simply provide us with the study protocol and CRF and all subsequent actions are our responsibility.
Clinical data management and applicable standards are complex, and this area of knowledge is full of jargon and specific procedures. We have spent many years developing a list of SOPs and engaging experts who understand configuration procedures. We believe that these tasks are challenging for the team, from the customer side, and we are ready to provide a complete service for system configuration and validation. As a result, you will receive a ready-to-go system prepared to collect data for your specific study.
With this service we create accounts for your staff, conduct training on OnlineCRF usage and all communication with study sites remains your area of responsibility. Our role is to maintain the eCRF system during data collection, support users, ensure stability and save backups to secure storage.
The main list of activities we provide in an OnlineCRF rental model:
- Audit of incoming documents.
- Creating a system requirement for OnlineCRF.
- Developing a Data Management Plan and System Validation Plan.
- Deploy the system at xxxx.onlinecrf.com.
- Configuring the system in accordance with previously created requirements.
- Implementing eCRF to create all required visits, pages, and automatic checks.
- Validating eCRF to be sure that electronic case report forms perfectly fit paper CRF.
- Preparing the full set of validating documents.
- Performing User Acceptance Test (UAT).
- Training Sponsor representatives.
- Granting access to users
During the data collection period, investigators fill in web forms, and Sponsor’s staff performs all tasks: remote monitoring, clinical monitoring, query generation, and resolution and page verification. In the end, the database undergoes soft and hard lock, and data is exported in a format which is convenient for statistical processing. eCRFs can be exported in PDF format and archived.