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 must happen__________.
At least annually
__________ are any alteration or departure from the IRB-approved research plan as defined in the study protocol.
Protocol Deviations
As per Good Clinical Practice (GCP) 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)
_____summarizes information about an investigational product, such as dose, frequency, method of administration and safety monitoring.
Hint-not protocol or package insert
Investigator's Brochure
Visits conducted by the sponsor/CRO to perform source data verification and review are documented on the _____ log.
Monitoring Log/Site Visit 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)?
Sponsor (can also instruct the pharmacy to destroy or return the IP)
_____ are conducted periodically by a study monitor 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 ________ include details and instructions that the pharmacy and PI need to properly prescribe a drug including approved formulations and dosage.
Package Insert
_______ populations include children, pregnant women, and prisoners.
Vulnerable
What is the timeline for an investigator to report a Serious Adverse Event to the sponsor?
Within 24 hours of becoming aware or as dictated in the protocol
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 studies.
1572