Any untoward change in the baseline health of the subject; any undesirable experience that occurs while a subject is taking part in a study whether or not it is attributable to use of the investigational product.
What is an Adverse Event
100
This type of documentation includes: (1) approved IRB version date, (2) patient's questions answered; (3) verbalized understanding of risks/benefits, (4) copy of signed consent given to patient and placed in medical record, and (5) all study procedures initiated after signing consent.
What is the documentation of the ICF process.
100
A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject
What is a Case Report Form (CRF)
100
This Allphase individual ran the Boston marathon earlier this year
Who is Manuelle?
100
Where Allphase SOPs/BPG's currently housed
What is on the Allphase Learning Management System (LMS)
200
Any experience that is fatal or life threatening , is persistent or significant disability, requires hospitalization >24 hours, or prolongs an existing hospitalization, or is a congential anomaly/birth defect.
What is a Serious Adverse Event
200
Protocol amendments are only prepared when there has been a change to the protocol. True or False
What is False? Protocol amendments may describe changes, but can also be prepared to clarify information in the protocol
200
A printed document designed to record all of the protocol required information that will be checked as part of the standard edit checks for a clinical study
What is a Data Validation Plan (DVP)?
200
These two Allphase employees were born in this country
What is Romania?
300
Sponsor must be notified within 24 hours of coordinator/investigator knowledge of occurrence
What is a SAE
300
Requires an impartial witness
What is during the informed consent process when a subject or subject's legal representative cannot read
300
A printed document designed to describe all of the DM activities and timelines planned for a clinical study and to document the process of all DM activities included in a clinical study.
What is a Data Management Plan (DMP)
300
This Allphase employee loves camping with his family in Algonquin Park
Who is Phil?
400
An adverse event or reaction, the nature severity of which is not consistent with the applicable product information (e.g. IB for an unapproved IP or package insert for an approved product
What is an unexpected Adverse Event?
400
A unique identifier designed to protect the subject's anonymity
What is a subject ID Code
400
Document describes the entry of the CRF data into the clinical database for a clinical study and provides a point of reference for data entry personnel during the study
What is a Date Entry Manual (DEM?)
400
This employee is an avid competitive swimmer
Who is Patty?
500
DS 501
What is Allphase SOP Reporting and Recording Serious Adverse Events
500
A child's affirmative agreement to participate in a clnical investigation
What is an Assent?
500
Name of Allphase Data Platform
What is DataInsight?
500
This person is responsible for invoicing our clients