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Top 10 Ways to Ensure Your eClinical Technology is FDA Compliant

Ensure your eClinical technology is FDA compliant

Keeping up with FDA requirements can be a full time job. There are several FDA guidances related to using eClinical technology in clinical trials with two released this year alone. I recently conducted a webinar that focused on this topic which included a list of ways to ensure your eClinical technology is FDA compliant. The list appears below. For those of you who missed it, this webinar is now available on-demand

  1. Have Standard Operating Procedures (SOPs) to document how you test your eClinical systems
    According to Guidance for Industry Computerized Systems Used in Clinical Investigations any system ‘relied on by an applicant in support of a marketing application’ needs to be tested to make sure data is being handled correctly. This certainly applies to EDC or IRT systems, but can apply to CTMS and safety systems if you use the data from these systems to make business decisions. Sponsors should have established SOPs which ensure that this testing is done with sample requirements documents, testing, and report templates.
  2. Have a training plan that includes deactivation steps for inactive users
    Users need to be trained on their specific function in the eClinical technology systems they will be using.  Training records need to be kept and updated throughout the trial.  It is good practice to audit these records periodically to make sure users who are no longer on the team do not have access to the data.
  3. Document the source of all incoming data
    According to the Guidance for Industry - Electronic Source Data in Clinical Investigations,  “When a system, device, or instrument automatically populates a data element field in the eCRF, a data element identifier should be created that automatically identifies the particular system, device, or instrument as the originator of the data element. “ This means that data coming from an IRT or Central Lab needs to have an identifier that shows where the data originated.
  4. Have a plan to “check” incoming data
    Data being imported from another system needs to go though some quality steps to assure it is correct.  Be sure to conduct a User Acceptance Test (UAT) with sample data to make sure no data is being lost or altered.  It is best practice to check data periodically for completeness and correctness. 
  5. Make investigators and sites electronically accountable for data they originate
    The investigator is responsible for maintaining accurate case report forms. If the data on the case report form comes from an electronic source that originated at the clinical site, the investigator is responsible for that data too.
  6. Be smart about how you monitor data to focus on quality
    According to Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring “There is a growing consensus that risk-based approaches to monitoring, such as focusing on the most critical data elements, are more likely to ensure subject protection and overall study quality, and will permit sponsors to monitor the conduct of clinical investigations more effectively than routine visits to all clinical sites and 100% data verification.” While we strive for uniformity in clinical trial standards, the reality is not all sites are created equal. Some sites will need more oversight than others to ensure eClinical technology is FDA compliant, so create a plan that documents how you will determine which sites need more attention than others. 
  7. Audit your vendor to assure the software is compliant with guidances (audit trail, user name, etc.)
    It is in your best interest to review your eClinical technology vendors’ software development lifecycle (SDLC) to make sure they have proper processes and procedures in place regarding the release and maintenance of their software.  If you don’t have a QA group, put together a checklist based on Guidance for Industry - Computerized Systems Used in Clinical Investigations and ask to see the vendor’s relevant documentation.
  8. Make sure all users understand their role in guaranteeing clinical data quality
    Documenting roles and responsibilities, then making sure training is done to cover all items on the list is useful to make sure that each user understands what is expected of them during the course of the study. 
  9. Create a historical record document for each clinical study detailing the systems are used, related SOP’s, testing plan/signoff, changes, users, etc.
    It is important to be able to answer questions years after the trial has ended about which systems were used and what SOP’s were being followed to conduct the study. By creating a standardized file that details the systems that were used, the related SOPs, testing plan and signoff, changes, users, and other important facts, you’ll be ready for any kind of an audit.  
  10. Implement CDISC standards
    The FDA will be requiring submissions in the CDISC standard format by 2016, and if that isn’t reason enough, please see my related blog posts Setting Up an EDC Study Using CDISC Standards and Clinical Data Exchange Standards between FDA and Pharma Industry for details on this topic in relation to eClinical technology.

View FDA guidance & eClinical technology webinar!



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Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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