General Study Documents
________ individually and collectively permit evaluation of the conduct of a trial and quality of the data produced.
Essential Documents
_____ is responsible for verifying that storage conditions for Investigational Product (IP) are acceptable.
The sponsor
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must happen__________.
At least annually
__________ can be unintended, unanticipated, or an intentional departure from the procedures or process in the IRB-approved protocol.
Protocol Deviations
How often does the CV for study staff need to be updated, signed, and documented?
Every 2 years
The PI or research coordinator must advise a subject about the potential benefits, risks, and alternatives involved in any research procedures or treatment and document this on the _____________.
Informed Consent Form (ICF)
_____ is the document that describes the expectedness of an Adverse Event (AE) or Adverse Drug Reaction (ADR).
Investigator's Brochure
Visits conducted by the sponsor/CRO to perform source data verification and review are documented on the _____ log.
Monitoring Log
Accurate reporting of adverse events is most important for__________.
Subject Safety
The PI assigns duties based on education, experience, and training; these responsibilities are documented on the _______.
Delegation of Authority Log
_____ describes the study aims, research design, all study-related activities and procedures.
Study Protocol
______ is used to capture lot numbers, expiration dates, dates returned, amount dispensed, and more.
Drug Accountability Log
____ is responsible for oversight of a clinical trial at a study site.
Principal Investigator
____ are any untoward or unfavorable medical occurrence in a study subject.
Adverse Events
CITI Good Clinical Practice (GCP) training must be renewed every____ years, and Human Subject Research (HSR) every ____ years.
3 and 5
_____ are original documents (AKA certified true copies), data, and records where information is first captured (e.g: medical records, clinical/office charts, laboratory notes, etc.)
Source Documents
____ is responsible for the destruction of Investigational Product(s)?
A)Pharmacist
B) PI
C) Sponsor
C) Sponsor
_____ are conducted internally or periodically by a sponsor to verify that the conduct of the trial is in compliance with the IRB-approved protocol, and regulatory requirements.
Monitoring Visit
___ are events that result in death or life-threatening situations (may require hospitalization).
Serious Adverse Events
The _____ is used to document all training completed by site study staff that is not otherwise documented by a training completion certificate.
Training Log
_____ are detailed written research-related activities or procedures and are site-specific.
Standard Operating Procedures (SOP)
The ________ includes details and directions that the pharmacy and PI need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations and dosage, and administration instructions.
Package Insert
_______ populations include children, pregnant women, and prisoners.
Vulnerable
What is the timeline for an investigator to report an Serious Adverse Event to a sponsor?
A) 7 days working days
B) 24 hrs
C) Immediately
D) At the next monitoring visit
C) Immediately
A ____ form is a binding legal contract between the Principal Investigator (PI), the trial's sponsor, and FDA.
All investigators and sub-investigators must be added to this form for IND/IDE studies.
Form 1572