The adoption of digital solutions is becoming commonplace due to the increased efficiencies of electronic solutions in maintaining compliance in clinical trials. In this blog post, we’ll explore the critical components of going digital with electronic delegation of authority, electronic signatures (eSignatures), and audit trails – and how they are safeguarding compliance and patient safety in modern clinical trials.
Principal Investigators (PIs) bear the ultimate responsibility for the oversight of clinical trials, a role that encompasses ensuring the integrity of the study, the safety of participants, and adherence to regulatory standards. A crucial aspect of this oversight is the delegation of authority (DOA), a process through which PIs assign specific tasks and responsibilities to members of their research team. This process is a fundamental requirement to verify that every task in a clinical trial is carried out by individuals who have the appropriate qualifications, training, and experience. Proper delegation helps maintain compliance with regulatory requirements and safeguards the quality and integrity of the trial.
What is a DOA in Clinical Trials?
The Delegation of Authority (DOA) in clinical trials is a formal process where certain responsibilities and decision-making powers are assigned to specific individuals or roles within a research team. These responsibilities include tasks such as overseeing the conduct of the trial, ensuring compliance with regulations and protocols, handling data management, and making critical decisions related to patient safety and study progression.
Traditionally, the DOA process has been managed with paper-based systems. These systems required PIs and their delegates to manually fill out, update, and maintain extensive paperwork that documented the delegation of various tasks. This approach has many challenges. Paper-based DOA logs are cumbersome to update and maintain, especially with sites that have multiple locations that result in the need for time consuming interoffice mailings. They also pose a high risk of errors, such as outdated information or miscommunications about the current responsibilities of team members. Moreover, in clinical trials, where tasks and personnel roles can change frequently, the limitations of paper-based systems often led to inefficiencies and compliance risks. For these reasons, the DOA log is often the first and most commonly reviewed documents by monitors and auditors.
The Benefits of Electronic Delegation of Authority
The adoption of electronic delegation of authority logs transforms traditional processes, delivering many advantages over paper-based systems. One of the primary benefits is the reduction of errors associated with manual data entry. With the capability to update information in real-time, electronic DOAs ensure that data remains current and accurate, thus enhancing the overall integrity of the information stored.
Moreover, electronic DOA systems provide increased accessibility for authorized personnel. Team members can access these logs from multiple locations, facilitating easy updates and reviews without the need for physical storage space required by paper logs. Electronic DOAs also automatically record changes and timestamps, establishing a clear audit trail which is critical for regulatory compliance in clinical trials.
Facilitating better communication among team members, electronic DOAs allow changes and updates to be viewed in real-time, enabling better alignment regarding task delegation and responsibilities. This real-time visibility promotes efficiency in information retrieval and saves time compared to navigating through pages of paper logs. Additionally, these systems can be programmed to send out notifications or reminders when tasks need to be performed or reviewed, preventing important tasks from being overlooked.
Particularly important for large-scale studies involving multiple sites or teams, electronic DOAs help maintain consistency in how information is recorded and reported. Robust security measures, such as encryption and password protection, safeguard sensitive information more effectively than paper logs, ensuring data confidentiality and integrity.
Furthermore, eReg systems can integrate eDOA functionality into related workflows to cut down on additional steps and errors. Instead of being just another activity, once individuals are added on the eDOA, users can automatically access current key study documents based on their role, eliminating the need for document distribution. Also, once added to the eDOA, study team members’ relevant credentials are automatically linked to the study binder at that time and throughout their involvement in the study. Lastly, there is an option to route documents sent for signature, review and/or training to all study team members to ensure efficient and accurate records.
Electronic Signatures (eSignatures): Guidance from the FDA
The FDA Draft Guidance on Electronic Systems, Electronic Records, and Electronic Signatures provides guidance on electronic signatures under 21 CFR Part 11. This regulation sets forth the criteria under which the FDA considers electronic records and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. 21 CFR Part 11 applies to all FDA-regulated industries, including pharmaceuticals, medical devices, biotech, and other FDA-regulated sectors where electronic records and electronic signatures are used. Key aspects of the FDA’s guidance on electronic signatures include:
- Electronic signatures must be unique to the individual using them and securely linked to their electronic record. The system should ensure that the electronic signature cannot be repudiated and is as legally binding as a handwritten signature.
- Where identification codes and passwords are used as electronic signatures, systems must employ controls to ensure their security and integrity. This includes maintaining the confidentiality of password and ID codes and regularly checking for their unauthorized use.
- Electronic records must include secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Audit trail documentation is crucial for traceability and accountability.
- The system should ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.
- Organizations intending to use electronic signatures must submit a certification to the FDA, declaring that the electronic signatures in their system are intended to be the legally binding equivalent of traditional handwritten signatures.
Personnel should be trained in the use of electronic signature systems, ensuring they understand the implications and legal significance of their electronic signatures.
Advantages of Electronic Signatures
eSignatures streamline the signing process, drastically reducing the time and resources required compared to manual methods. With the ability to electronically sign documents from any location with internet access, the need for physical presence or postal services is eliminated, resulting in improved operational efficiency.
Moreover, the use of eSignatures facilitates faster turnaround times for document signing. Documents can be signed and returned within minutes, accelerating study timelines and expediting decision-making processes. This swift turnaround is instrumental in maintaining momentum and meeting study milestones in a timely manner.
Security and compliance are paramount in clinical trials, and eSignatures offer robust features to address these concerns. Encryption and audit trail functionalities ensure the integrity and authenticity of signed documents, helping organizations adhere to regulatory requirements such as FDA 21 CFR Part 11. These security measures instill confidence in the validity of electronic signatures and contribute to maintaining regulatory compliance.
The adoption of eSignatures also reduces the risk of errors associated with manual signature processes. Validation checks and verification mechanisms embedded within electronic signature platforms help minimize mistakes, enhancing the accuracy and reliability of signed documents. This reduction in errors translates to improved data quality and integrity throughout the trial process.
Importantly, eSignatures promote accessibility and collaboration by enabling remote signing. Stakeholders dispersed across different locations can securely sign documents without the need for physical meetings, appointments or travel. This facilitates seamless collaboration and timely execution of critical documents.
Audit Trails - Ensuring Transparency and Compliance
Audit trails play a crucial role in ensuring transparency and compliance within clinical trials. Defined as a comprehensive record documenting every action taken within a computer system, audit trails provide invaluable insights into system access and operations conducted over a specified timeframe. This level of transparency is essential for upholding regulatory standards and safeguarding data integrity, thereby reinforcing trust in the research process. By meticulously tracking user activity, audit trails enable organizations to identify who accessed the system, what actions were performed, and when these actions occurred. This granular level of detail is instrumental in detecting unauthorized access, identifying potential security breaches, and mitigating risks associated with data manipulation or tampering.
Robust audit trails significantly enhance the reliability and trustworthiness of data in clinical research settings. The Society of Data Management underscores the importance of audit trails in overall quality system. According to an eCF/SCDM ATR Industry Position paper, many pharmaceutical companies are beginning to investigate ways to establish risk-based governance for overseeing audit trails. They are broadening their goals from merely identifying fraudulent data to encompassing a range of other critical areas. These include the steps involved in decision-making, the improper handling of data, the presence of anomalous data, the reporting of inaccurate results, enhancements in processes, and the identification of training requirements.
Audit trails play a pivotal role in maintaining transparency, accountability, and compliance within the clinical trials. By meticulously documenting user activities and system interactions, audit trails uphold data integrity, mitigate risks, and foster trust in the research process, thereby reinforcing the credibility of research outcomes and regulatory adherence.
Final Thoughts
The transition from paper to digital processes like electronic DOAs, eSignatures, and audit trails is about embracing a more efficient, secure, and compliant clinical research experience. The synergy of electronic DOAs, eSignatures, and audit trails represents a major advancement in digital workflow management, offering enhanced efficiency, security, and accountability. Electronic DOAs, by digitizing the process of task assignment and responsibility delegation, establish clear lines of authority and empower individuals with the necessary permissions to make decisions and take action. This digital framework eradicates the delays and potential errors inherent in manual approval processes, facilitating swifter and more agile decision-making procedures.
Complementing electronic DOAs, eSignatures revolutionize traditional methods of document signing and authentication in modern clinical trials. Offering a secure and legally binding alternative to in-person signatures, eSignatures enable stakeholders to electronically sign documents from any location and device. This not only expedites transactional processes but also enhances accessibility and convenience for all parties.
Meanwhile, audit trails serve as the bedrock of transparency and compliance within this digital ecosystem. By meticulously documenting every user action, timestamp, and system event, audit trails provide comprehensive visibility into the lifecycle of documents and processes. This level of transparency is invaluable for regulatory compliance, allowing organizations to demonstrate adherence to established protocols and swiftly identify any deviations.
Together, electronic DOAs, eSignatures, and audit trails create a seamless and highly efficient digital workflow. Electronic DOAs facilitate task delegation and authorization, eSignatures enable secure document signing and approval, and audit trails ensure transparency and compliance. By automating and integrating these key components, clinical research sites can streamline operations, minimize errors, and expedite decision-making processes.
