The Principal Investigator (PI) of any study, be it drug or device, has many responsibilities, including ensuring regulatory compliance, overseeing the conduct of the study, and safeguarding the well-being of study participants. Another one of these responsibilities is to maintain a list of appropriately qualified staff members who they’ve delegated significant study-related duties and tasks to.
A Delegation of Authority log (DOA) does just that - it lists the qualified individuals to whom the PI has delegated significant trial-related duties. The DOA log documents the roles and responsibilities assigned to each research study team member. Although the PI may delegate tasks, they retain ultimate responsibility for the overall conduct of the trial.
The DOA only suffices the first part of our initial responsibility. The second part is ensuring that those who are delegated these duties are indeed qualified by ensuring they have the relevant education, credentials, certifications, training, and experience.
The PI needs to ensure that there is adequate training for all staff participating in the conduct of the study, including any new staff hired after the study has begun to meet unanticipated workload or to replace staff who have left. What does adequate training look like?
- Are familiar with the purpose of the study, the protocol and all of its nuances, as well as the attributes of the investigational product
- Having a working knowledge of the regulations and standards for the conduct of clinical trials as well as the protection of human subjects
- Are capable of performing or have been trained to perform the assigned duties
- Are informed of any relevant changes during the conduct of the trial and receive additional training as appropriate.
Managing these logs and documents manually can be time consuming and prone to errors. This is where leveraging a centralized digital solution like the Cloudbyz CTMS becomes highly advantageous.
With the Cloudbyz eDOA and Training Tracking, your delegation and training information is centralized in one accessible platform, reducing the risk of data loss and ensuring that updates are immediately reflected across the system.
Don’t wait weeks for a paper DOA to make its way around the office. With our built-in fully compliant eSignature, you can easily route your eDoA for review and signature with a few clicks. Changes to delegations can be made and tracked in real-time, ensuring that all team members and stakeholders are immediately informed of new assignments or changes.
By automating the training and delegation process, it reduces overall administrative burden, allowing the PI and study staff to focus on more critical aspects of the study. Enable notifications to automatically notify staff of assigned tasks and upcoming training requirements for renewal deadlines, helping to maintain compliance and prevent lapses in training.
By adopting a electronic solution like ours for Delegation of Authority and Training Logs, study teams can significantly enhance efficiency, accuracy, and compliance. These tools not only simplify administrative tasks but also ensure that study conduct adheres to the highest standards of regulatory and operational excellence.
To learn more about Cloudbyz products, contact info@cloudbyz.com.
Resources
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry. Silver Spring, MD: FDA; 2018.
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health. Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects. Silver Springs, MD: FDA; 2009
