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ISO 14155
CFR
Study Development
Start-up
SIVs
100
The document that provides the investigator with sufficient safety or performance data to justify human exposure to an investigational device.
What is Investigator's Brochure
100
This must be provided by all investigators at the beginning and end of the study.
What is Financial Disclosure
100
The absence of errors that matter in the decision making process.
What is Quality by Design?
100
The phase that involves offering suggestions for potential study sites for a specific project or program.
What is the Nomination Phase?
100
At a minimum, these individuals MUST be present to have a complete SIV.
What is the PI and Research Coordinator.
200
The local authority that gives approval to conduct a clinical study
What is Ethics Committee
200
The document that describes the tests and procedures required to be performed in support of research.
What is the Investigational Plan?
200
The person on the study team who represents the US FCE / CPL perspective.
What is FCE Champion?
200
The final list of sites that will be considered for participation in the study.
What is the Approach List?
200
The document that tells the US FCE / CPL and FCRA which topics must be trained on during the SIV.
What is Training Plan?
300
The document providing a patient's agreement to participate in a study
What is Informed Consent
300
The entire packet of documents submitted to the FDA to request permission to conduct research on a medical device.
What is an IDE?
300
The person on the study team who represents the FCRA perspective.
What is FCRA Champion?
300
The site visit where the CPL will meet with the site Professor(s) and collect information specific to the execution of the study at their hospital.
What is Qualification Visit?
300
These forms are used to document what occurred during the Site Initiation Visit
What are the Training Log and SIV Report?
400
The document that provides assurance that a physician is qualified to participate in a study
What is CV
400
Prior to participating in any part of a clinical study, sponsor and site staff must complete this.
What is training?
400
The mobile phone application that enables you to visualize to have total site management at your fingertips.
What is the FCE Mobile Application?
400
What is the final list of sites who will be asked to participate in a study?
What is the Invitation List?
400
CVs, Training Log, Delegation of Authority Log, Local and National Approvals, Agreements and other study-specific documents.
What is required to activate a site?
500
Any untoward medical occurrence whether or not related to the investigational device
What is an Adverse Event
500
This document, typically signed by the hospital, the investigator and the sponsor must be executed before a study can be initiated at a site.
What is an Agreement?
500
The Plan that details the training that must occur for each individual who is participating in the study.
What is the Training Plan?
500
The person who has primary responsibility for site nomination and qualification in their territory / region.
What is the US FCE / CPL?
500
Is responsible to conduct all training at an investigational site.
SJM staff