FDA Guidance on Computerized Systems in Clinical Trials

The Food and Drug Administration's guidance on the use of computerized systems in clinical trials emphasizes the importance of validating the process, verifying the design, and qualifying the operation to ensure the accuracy and reliability of the data. This approach is essential in the development of software quality assurance (SQA) programs, which aim to recognize that it is not possible to test every point in the operating, network, and application software used in a business system.

Key Takeaways:

• The three core points of an SQA program are to validate the process, verify the design, and qualify the operation.
• Rigorous and consistent development standards and methods should be used to ensure that the quality level of the subset is representative of the quality level of the entire software system.
• Most managers consider computer system validation (CSV) an after-the-fact "rubber stamping" activity, but it is better to do it before and ensure that the system works rather than afterwards with a faulty product.
• Upgrades to the system should be done all at once, rather than piecemeal, and rigorously validate the system to ensure that records are retrievable.
• Companies should make sure that validation is integrated throughout the software development life cycle to ensure that the software can be installed properly, works as expected, and will be used as intended.
• Each trial should be considered a unique, separate implementation, and there should be complete system validation for each trial, including validation of the browser and creation of a separate way to control browser access for each trial.
• The use of the Internet in clinical trials requires companies to consider separating out e-mail related to the subject from other e-mail, encrypting data, or setting up private networks for confidentiality.
• Hand-held patient devices can provide reliable data, controls for who input the data, and when, faster, clean coded data, and high confidentiality.
• Security features for electronic patient diaries include physical security, an audit trail, log-on, and control of data entry, and certification of electronic signatures should be submitted in paper form to FDA before or at the time that an electronic signature is used.

Statistics:

• It is estimated that using computerized systems in clinical trials can reduce the time and cost associated with the validation process.
• A properly validated electronic system can produce a verifiable copy of data, probably even better than a human being could.
• The use of electronic patient diaries can increase data quality by up to 90% compared to paper-based systems.
• Hand-held patient devices can provide an audit trail as nothing is ever deleted, and all data are time and date stamped.
• The average cost of validating a computer system can range from $500,000 to $1 million, but this cost can be reduced by integrating validation into the software development life cycle.

Sources:

• Thomas Quinn, president of the Hollis Group, at the Drug Information Association conference in Washington, Dec. 3.
• Paul Bleicher, Chairman and Chief Scientific Officer, PhaseForward.
• Francis Wouters, vice president, sales and marketing for MiniDoc.
• FDA Guidance on Computerized Systems in Clinical Trials.