Frequently Asked Questions

  1. What are the most important factors that impact OnlineCRF price estimation?
    The price of OnlineCRF is influenced by many factors, the most important of which are:
    • Size and structure of a CRF. The complexity of a CRF is the number of fields and questions and the necessity of automatic checks of the entered data.
    • The number of patients. Many subjects need more time to be included in the study. Accordingly, the duration of use and support of the system will increase.
    • The total duration of the project. The long-term project needs more resources than the short-term study.
    • The number of research centers. A large number of centers require more resources to train members and to process inquiries and support users.
  2. How long will it take to configure the system?
    The EDC system configuration for the requirements of a clinical study takes 4-6 weeks.
  3. Is the data stored on your company’s server? Where is it located?
    We store DBs and other data at DigitalOcean (https://www.digitalocean.com). It is one of the leading European providers of cloud services (> 150 000 instances). Today servers are physically located in North America (Ashburn, Atlanta, Chicago, Dallas, Denver, Los Angeles, Miami, New York, San Jose, Seattle, Toronto) and Europe (Amsterdam, Frankfurt, London, Madrid, Milan, Paris, Stockholm, Warsaw). Asia is covered by servers currently in beta mode (Hong Kong (beta), Manila (beta), Seoul (beta), Singapore (beta), Tokyo (beta)).
  4. Can data be restored in case of disaster?
    The database saves incrementally every hour, and we store 24 subsequent DB snapshots on the last day. Additionally, we have one- and two-week-old snapshots. All the data for each project is saved in 2 physically separate data centers simultaneously. If one of the servers is destroyed, we can easily recover the data from the other.
  5. Are there any limitations on the data storage period?
    At the end of each trial, we run soft and hard database lock. It means that after the end of the trial you can modify the data (soft lock) before it is archived (hard lock). Archived data is kept for 15 years and data can be reviewed on request.
  6. What international standards does OnlineCRF comply with?
    OnlineCRF complies with:
    • FDA 21 CFR Part 11
    • GCDMP
    • FDA: Computerized Systems Used in Clinical Trials
    • GDPR
    To read more information about supported standards follow the link
    https://onlinecrf.com/standards.html
  7. Is the system SaaS?
    Yes, OnlineCRF is SaaS and can be accessed by users using thin client via a web browser. The URL begins with "https://". Each project is configured by our Clinical Data Management team and is accessible via a dedicated URL.
  8. Do you encrypt data?
    Yes, all data which is transferred from/to the browser is encrypted via an SSL certificate. Each project is accessible with “https://”
  9. Can we use the domain name of our Company?
    We deploy OnlineCRF on the server and assign it with a name in the format https://xxxxx.onlinecrf.com. ххххх — is the name of your company or project. In certain cases, OnlineCRF can be managed within the “Private Label” model where OnlineCRF brand name is hidden and it uses your company domain and logo.
  10. What is the list of documentation that can prove the validity of the system, and can you provide it?
    We provide a full package of documents that confirm the validity of the OnlineCRF system. Among them are:
    • System validation report — a final validation report. It contains the results of all the checks made above. It is the final document that confirms that the system is validated and meets the requirements of the study;
    • System start-up checklist — a document which confirms that all system components are configured properly. It is completed after the full system setup is done and affirms that the EDC is ready to collect data.
    And there is another document. A list of essential documents that validate the system configuration for the project can be downloaded here.
  11. Can you localize the system for different languages?
    We can customize the OnlineCRF interface in any language.
  12. Are there any limitations on the number of user accounts?
    Our load tests confirm that the system supports up to 200 user accounts. We have several projects with nearly 100 user accounts.
  13. Describe which user roles are supported by the OnlineCRF
    OnlineCRF support all conventional user roles. Moreover, custom roles can be easily configured according to your needs. The conventional set of roles and user rights is:
    • Investigator. Can create subjects, enter data to a CRF, answer a query, make changes in a CRF before database closing.
    • CRA (monitor). Has access to the information in a specific study center. Can conduct remote monitoring of data entered to CRF, generate queries.
    • CTL. Has access to view all study information, but as a rule, cannot change it.
    • Project manager. Has access to project information, can create CRA accounts and receive all important e-mail notifications (SAE, AE, etc.).

    This is just a standard set of roles and their rights. Our team can configure custom user roles and their rights according to the requirements of your project.
  14. How to create a query? How to manage a query resolution?
    The query can be generated by pressing a button, which is placed near the CRF fields. All information about query resolution is saved to the report. You can access it at any time.
  15. Is there any possibility to export data? How?
    The data can be exported at any time during the trial. To export a specific dataset, you can use multiple filters and settings.
  16. Is the system available on mobile devices, tablets etc.?
    The system interface is adapted to any device, including mobile devices and tablets. You can access OnlineCRF from any device, you just need to have a browser and Internet connection.
  17. What kind of support can you provide?
    We provide second-line support. This means that we provide technical support for your EDC specialists if they cannot resolve issues themselves.
  18. What types of predefined reports are available?
    The project manager can generate three types of reports: Project status report, Subject status report, Visit schedule. Reports can be customized in accordance with project requirements.
  19. Can we use your system to manage data collection?
    OnlineCRF allows researchers to not only collect data. Via our system, users can manage projects using special modules and functions. For example, The Dashboard makes a great boost for remote monitoring and RBM activities etc.
  20. What are the biggest differences between the other EDC systems on the market?

    Features for real-time project tracking

    The OnlineCRF system provides a tool for quick monitoring of the dynamics of trial and project bottleneck identifying - dashboard. It shows the study progress of each subject’s status. As a result, the dashboard displays the number of created, randomized, excluded patients etc. These parameters are displayed not just in the form of a table with numbers but are rendered in the form of a progress bar, which greatly facilitates the perception and analysis of information. You can get detailed information about the activity of individual investigators and study sites via the dashboard just in 3 clicks.

    Real-time validation rangers in eCRF

    EDC system OnlineCRF provides eCRF with an automatic check function for the entered values. This means that the eCRF fields do a real-time auto check of entered data (researcher cannot enter erroneous values, for example, height 270 sm instead of 170 or a weight of 900 kg). The uniqueness of these checks is that they work immediately after data is entered into the field. The system automatically compares the entered values ​​with ranges provided by the protocol and signals if there is an error. Thus, the doctor is obliged to check the value before he or she fills out eCRF and saves it.

    This greatly improves the quality of the collected data and saves time for clarifying information.

    Great flexibility

    OnlineCRF system is created as a baseline system on the foundation of which all projects are set. Each clinical trial deploys a separate instance with its own specific functions and settings. This is the reason why the system, that is aimed towards a specific project, can be changed and vary a lot from the basic OnlineCRF. We can apply various changes, up to modifications at the level of the program code. If the client wants to carry out a project and its realization needs specific functionality, which is not found in any other system, we can discuss the possibility of modifying the functionality and algorithms at the source code level. After that, our team will set up and validate OnlineCRF. The client receives the system that is ready to collect clinical data in a particular project. Even if the client has no experience using the EDC, they can easily start working with the system without additional preparation.
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