General Study Documents
Documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.
What are Essential Documents?
According to ICH-GCP, who is responsible for verifying that storage times and conditions for Investigational Medicinal Product (IMP) are acceptable?
The monitor/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 intentional departure from the procedures or process approved by the sponsor and IRB
Protocol deviations
How often does the CV for study staff need to be updated, signed, and documented?
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)
What is the KEY document used to confirm the expectedness of an Adverse Event (AE) or Adverse Drug Reaction (ADR)
Investigator's Brochure
Used to log sponsor’s interim site monitoring visits, usually with the purpose of performing source data verification and review
What is the Monitoring Log?
Accurate reporting of adverse events is most important for__________
Subject Safety
The PI assigns duties based on education, experience, and training; this information is documented on the _______.
Delegation of Authority Log
Describes the study aims, research design, all study-related activities and procedures.
What is the Study Protocol?
This document is used to capture lot numbers, expiration dates, dates returned, amount dispensed, and more.
What is a Drug Accountability Log?
Who is responsible for oversight of a clinical trial at a study site?
Principal Investigator
Any untoward or unfavorable medical occurrence in a human study subject
What are Adverse Events?
CITI GCP training must be renewed every____ years, and Human Subject Research (HSR) every ____ years
3 and 5
Original documents (or commonly known as certified true copies), data, and records where information is first captured (e.g: medical records, clinical and office charts, laboratory notes, etc.)
What are Source Documents?
According to ICH GCP who is responsible for the destruction of Investigational Product(s)?
Pharmacist, PI or Sponsor
The sponsor
Can be conducted internally or periodically by a sponsor to verify that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s).
What is a monitoring visit?
Events that result in death or life-threatening situations (may require hospitalization)
Serious Adverse Event
Used to document all training completed by site study staff members that is not otherwise documented by a training completion certificate.
Training log
Detailed written instructions that ensure the uniform performance of a specific function.
What are 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
Product Insert
_______ subjects include children, pregnant women, and prisoners.
Vulnerable
What is the timeline for an investigator to report an SAE to a sponsor?
7 days working days, 24hrs, immediately or at the next monitoring visit
Immediately
All investigators and sub-investigators must be added to this form for IND/IDE studies.
A ___ form is a binding legal contract between the Principal Investigator (PI), the trial's sponsor, and FDA.
What is a 1572?