Remote Monitoring
Personalized evaluation and direct interaction to ensure data accuracy, adherence to protocol, regulatory documents and GCPs.
What is On-Site Monitoring?
This regulatory body is responsible for overseeing clinical trials in the United States, including decentralized clinical trials.
What is the Food and Drug Administration (FDA)?
The name of individuals enrolled in medical research according to the most ICH GCP changes.
What are research participants (not subjects)?
The Food and Drug Administration (FDA) regulations that address Institutional Review Board (IRB) requirements.
What is 21 CFR Part 56?
A required component of the Key Information section of the Informed Consent Form.
What is the Purpose of the Study?
Patient records, medication logs, stipend payments, study protocols, observation records and interview notes.
What are Source Documents?
One major challenge faced by decentralized clinical trials is ensuring this key aspect, which can sometimes be hindered by technology limitations or data privacy concerns.
What is data security?
In addition to physicians, these groups are now addressed by the Declaration of Helsinki.
What are individuals and organizations involved in medical research?
The Health and Human Services (HHS) regulations that address the protection of human subjects.
What is 45 CFR 46?
A good example to use for the key information section.
What is the use of bubbles, one for each of the required components?
Person who actively oversees the conduct of a clinical trial by regularly checking on study sites.
What is a sponsor monitor?
This model of decentralized trials involves patients participating remotely, but still receiving certain medical procedures or assessments at local clinics or healthcare providers.
What is a hybrid clinical trial?
Developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects.
Who is the World Health Organization?
The Food and Drug Administration (FDA) regulations that address the informed consent process.
What is 21 CFR Part 50?
The maximum length of the key information section.
What is no more than two (2) pages?
Data-driven approach that involves remote review of aggregated electronic data, including data analysis, to identify potential issues and trends.
What is Centralized Monitoring?
This software platform is commonly used in decentralized clinical trials to allow for the collection, management, and analysis of patient data remotely.
What is an electronic data capture (EDC) system?
A notable key change in the 2024 Revision of the Declaration of Helsinki.
What is zero tolerance of research misconduct?
In regulation 45 CFR 46, this addresses the protection of women and fetuses.
What is subpart B?
The location of the key information section of the informed consent form.
What is at the beginning of the informed consent form?
Evaluation activities, such as reviewing and verifying study data, assessing protocol adherence, using technology instead of physical site visits.
What is Remote Monitoring?
This type of technology is often used in decentralized trials to enable real-time remote monitoring and data collection from participants.
What is wearable technology?
Appendix C in ICH E6(R3) covers these essential documents.
What are Essential Records for the Conduct of a Clinical Trial?
The Food and Drug Administration (FDA) regulation that covers electronic signatures and electronic records?
What is 21 CFR Part 11?
The informed consent form and the informed consent process are the same.
What is No? The informed consent form is a document that documents the process, while the process is the ongoing exchange of information between the researcher and the participant to ensure they understand the study and can make an informed decision.