This training documentation is required from Emmes staff that transfers from one project to another.
What is a training/transfer checklist (see QA-02.01.)?
100
The word 'Emmes' means this, in Hebrew.
What is 'Truth'?
100
This section of a site visit report contains a short and comprehensive overview, including observations and findings, pertaining to the site’s conduct of the study.
What is the Executive Summary?
100
The Form FDA 482 is a Notice of this, which may be presented without prior notice.
What is an inspection?
100
The FDA must have this signed document within 30 days of the first enrollment or when there is a change in PI's.
What is the Form FDA 1572 /Investigator Agreement?
200
The timeframe in which the site monitoring plan is to be developed.
What is after finalization of the clinical protocol and prior to the selection and/or initiation of sites (see PM-05.04)?
200
A unified clinical trials platform developed by statisticians, medical officers, programmers, data managers and analysts.
What is Advantage eClinical?
200
The following are examples of some monitoring activities performed during this type of monitoring visit:
• Informed consent verification
• Review of demographic and eligibility criteria to confirm that all enrolled participants were eligible
• Data monitoring
What is an interim monitoring visit?
200
Emmes statisticians and data managers use this software tool to improve data quality.
What is integrity?
200
This document must reflect the staff member’s current affiliation with the study site and is collected for key/critical staff.
What is the Curriculum Vitae (CV)?
300
According to FDA, data recorded on paper or electronically must meet the fundamental elements of quality commonly abbreviated as “ALCOA”. The “O” in ALCOA stands for this.
What is "Original" (see GEN-01.01)?
300
Cancer/IRB Services, Vaccine & Infectious Diseases, Ophthalmology, Transplant/Allergy/Autoimmune, Maternal & Child Health/Substance Abuse Disorders, Neurology/Other are all examples of these.
What are the Emmes Research Units?
300
These are 4 data sources that could be reviewed, prior to and during a monitoring visit, to assess data integrity.
What are web data reports, SAS data files, data listings and source files?
300
This is what regulatory authorities, in most countries outside the US, call the drug being tested.
What is investigational medical product (IMP)?
300
This document can be collected in cases where an IRB Membership List is not available.
What is a statement from the IRB indicating compliance with regulatory requirements?
400
Site monitoring plans are to be reviewed at this interval.
What is at least annually or as otherwise specified in project SOP or project compliance/variance table (see PM-05.01)?
Note: Will also accept after modifications made to protocol.
400
2,136,763
What is the number of miles flown by Emmes staff in 2015?
400
These are 4 examples of why Close-Out Site Visits may occur, other than for the planned study closure.
What are:
• Sponsor withdrawal of IND
• Sponsor termination of site participation
• Site IRB termination of site participation
• FDA termination of study
400
Non-clinical laboratory tests on new drugs that are conducted in test tubes or other apparatus using only chemicals or cell cultures is often called this.
What is in-vitro testing?
400
This Hazardous Materials Training is required for all staff shipping biological specimens.
What is IATA - International Air Transport Training?
500
The FDA regulation to which the Emmes policy on “electronic” and “digital” signatures complies with.
What is 21 CFR Part 11?
500
Cabin John Mall, Potomac Maryland
Where was the location of the first Emmes corporate office?
500
These are the trial monitoring purposes outlined in GCP guideline 5.18.1 (Monitoring).
What are:
• The rights and well-being of human subjects are protected
• The reported trial data are accurate, complete, and verifiable from source documents
• The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with applicable regulatory requirement(s)
500
This is an uncommon drug “route of administration” that requires rubbing an ointment on the skin.
What is inunction?
500
These documents could be provided in cases when neither a CLIA or CAP are available.
When are the laboratory director or clinical pathologist’s (person who will be approving the laboratory reports) CV and medical license collected?