Are you already in compliance with ICH-GCP and EMA's Guideline on computerised systems?

by PQE Group

As technology transforms healthcare, regulatory authorities worldwide are urgently crafting modern frameworks to govern electronic systems in drug trials. While these innovative systems show promise, their infancy introduces variables that can impact trial outcomes. European regulators, at the forefront of embracing innovation, have established guidelines prioritizing data accuracy and patient well-being. The European Medicines Agency's groundbreaking guideline, effective from September 2023, sets a standardized framework extending oversight to healthcare facilities. This comprehensive approach mandates a stringent validation process for electronic tools, ensuring accuracy, reliability, and compliance. The article explores the evolution of regulatory frameworks, challenges posed by electronic systems, European initiatives, and the impact of the EMA guideline on ensuring data integrity in clinical trials.

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The Race To Develop Modern Regulatory Frameworks  

As technology advances and becomes increasingly integrated into healthcare, impacting the development of medicine and remedies, regulatory authorities around the world are racing against time to develop and implement modern regulatory frameworks that uphold the integrity and quality principles of drug clinical trials, especially when working with electronic systems. 

Challenges Posed by Electronic Systems 

These new innovative systems, although advanced and effective in many applications, especially in the development of drugs, are still in their infancy and have the potential to introduce new variables to drug trials, which may alter the results and compromise the entire process. Regulatory bodies have been working to introduce and implement updated frameworks that govern the use of electronic systems in drug trials for a while, with the sole intent of ensuring the technology produces accurate, reliable, and compliant-friendly results that safeguard patient safety and health.

How European Regulation is Adapting to Electronic Systems In Drug Clinical Trials 

European regulators have not lagged behind in embracing innovation in drug trials. Over the last few years, they have developed standardized protocols to prioritize data accuracy and ensure participant and patient well-being, aiming to enhance the quality and reliability of clinical research. The European Medicines Agency guideline on computerized systems and electronic data in clinical trials, published in March of 2023 and coming into effect six months later in September, was the culmination of comprehensive efforts to establish a standardized framework for the use of technology in clinical trials. 

Scope and Impact of the EMA Guideline on Electronic Systems Regulation 

What makes this guideline a solid foundation for electronic systems regulation is its coverage, which extends its application beyond sponsors and investigators to healthcare facilities where trials are conducted, in line with GCP-ICH E6 (R2) (Section § 4.9.0) principles. According to the EMA guidelines, all electronic tools and systems used throughout the clinical drug trial process are now subject to the framework's regulatory oversight. This means these tools and systems can only be used after going through a mandatory documented validation process to test and demonstrate that specific requirements are consistently met, and the electronic system is fit for its intended purpose, ensuring the highest standards of accuracy, reliability, and compliance.  

In accordance with GCP and ALCOA principles, the responsibility of collecting and storing original records of the entire clinical trial, including but not limited to electronic data, rests on the shoulders of investigators. These individuals, tasked with ensuring the accuracy, completeness, and integrity of the trial's documentation, play a crucial role in maintaining the highest standards of data management and compliance throughout the research process.

Operational Recommendations for Health Care Facilities 

While health care facilities bear the responsibility of implementing the measures set forth in the guideline, there is no single approach to achieving GCP compliance. Despite this, these facilities can take key steps to ensure they meet their compliance goals, which include: 

  1. Keeping accurate and up-to-date inventory records of systems and electronic tools used during the trial.
  2. Creating a multidisciplinary team which incorporates essential members in clinical trial operations, with diverse expertise, including physicians, pharmacists, nurses, GCP quality personnel, IT experts, risk managers, to perform a risk analysis for each system from a GCP perspective.
  3. Evaluating the validation status of each system according to its assigned risk category with input from the supplier when possible and conducting a gap analysis by comparing the system's status to the requirements outlined in the EMA Guideline.
  4. Involving the health facility's IT personnel and end-users in the validation and documentation process in a manner proportionate to the GCP criticality of the system. 

 The implementation of ICH-GCP regulations and EMA guidelines on computerized systems and electronic data in clinical trials will significantly contribute to safeguarding patient health and maintaining the integrity of drug clinical trials in the European life sciences industry. These measures will not only protect the patient’s health but also safeguard the well-being and rights of participants who make the trials possible.

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