Property:RefPreview
From GxPlex
Auto-derived 200-character preview of this reference's content, used in Document pages' References list.
U
IV. RECOMMENDATIONS
[...]
C. Source Documentation and Retention
When original observations are entered directly into a computerized system, the electr… +
IV. RESPONSIBILITIES FOR INFORMED CONSENT
[…]
B. The Clinical Investigator
The clinical investigator is responsible for protecting the rights, safety,… +
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification +
IV. RISK-BASED MONITORING
[…]
A. Identify Critical Data and Processes to be Monitored
[…]
• Verification that informed consent was obtained appropriat… +
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence +
IV. RISK-BASED MONITORING
[…]
A. Identify Critical Data and Processes to be Monitored
[…]
• Adherence to protocol eligibility criteria designed to exc… +
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct +
IV. RISK-BASED MONITORING
[…]
A. Identify Critical Data and Processes to be Monitored
[…]
• Conduct and documentation of procedures essential to trial… +
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. +
IV. RISK-BASED MONITORING
[…]
A. Identify Critical Data and Processes to be Monitored
[…]
Other types of data (e.g., covariates such as concomitant tr… +
I
Independent Data Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)
An independent data-m… +
Independent Data Monitoring Committee (IDMC)
An independent data monitoring committee (e.g., data safety monitoring board) that may be established by … +
U
Independent ethics committee (IEC) means a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human… +
E
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 1, 3, 4 +
Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination
1. If the sponsor has tempo… +
Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
1. If the sponsor has … +
Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
1. If the sponsor has … +
Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
1. [...] In the event t… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 5 +
Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination
5. Irrespective of the outc… +
I
Informed Consent
A process by which a participant or their legally acceptable representative voluntarily confirms their willingness to participate in … +
E
Informed consent
1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragrap… +
Informed consent
1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragrap… +
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 1 +
Informed consent
1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragrap… +
I
Inspection
The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records and any other resources that are… +
G
Inspection findings
At the end of the inspection the inspector will give you a verbal summary of the inspection findings and allow you the opportunity… +
