Clinical Oversight of Patient by PI
Description
The principal investigator (PI) has key oversight duties when it comes to protecting and managing patients in a clinical trial. These include:
- Evaluating patient eligibility: The PI is responsible for assessing if a patient meets the inclusion/exclusion criteria and would be an appropriate candidate for the clinical trial.
- Obtaining informed consent: The PI must ensure the informed consent process is conducted properly and that the patient understands the risks, benefits, protocols, and their rights.
- Providing medical care: The PI must monitor the patient's health throughout the trial, order appropriate tests, provide standard of care and/or study interventions, and handle any medical emergencies.
- Assessing safety: The PI must continually evaluate patient safety by grading and reporting adverse events and taking action, such as dose modifications, as per the protocol.
- Maintaining records: The PI must keep accurate and complete medical records for each patient throughout the clinical trial per regulations.
- Managing privacy: The PI must take measures to protect patient privacy including keeping medical records confidential and secure. Following up after the study. The PI should provide patients with results, information on continuing care, and access to the study drug or device after the trial as needed.
DCT-specific Considerations/Inputs
There are some key differences in PI oversight responsibilities in a decentralized clinical trial compared to a traditional trial:
- Remote supervision: In a decentralized trial, patients may complete study visits and procedures at local sites closer to home rather than traveling to the main study site. This requires the PI to provide oversight and supervision remotely.
- Coordination with local staff: The PI must coordinate with and train any local physicians, nurses, or coordinators conducting study procedures and monitoring patients at remote sites. Clear communication and delegation of duties is crucial.
- Reliance on mobile technology: Decentralized trials rely heavily on mobile health technology, telemedicine, and digital tools for remote data collection, patient monitoring, and communication. The PI must be comfortable using and validating these technologies.
- Local lab/testing management: The PI may need to help identify reliable local labs for tests, coordinate sample transportation logistics, and confirm normal ranges are accurate for remote sites.
- Different or decreased in-person visits: The PI may have fewer opportunities for in-person interaction with patients in a decentralized trial model. Special efforts should be made to build patient rapport and trust remotely.