Session 2 Flashcards
According to ICH GCP which document shows that the site is suitable for the trial?
Pre-trial monitoring report
What is the approximate number of healthy volunteers needed to conduct a Phase I Trial?
20 to 80 healthy volunteers are to study the activity and monitor potential toxicity in people
An IND becomes effective if the FDA approves within how many days?
30 days
Use of a marketed drug or biologic product for an unlabeled indication in practice of medicine is not subject to IND regulation.
True
After the FDA approves the drug, it is then made available for physicians to prescribe to patients. At this point, the pharmaceutical company is no longer responsible for submitting periodic reports to the FDA regarding any unknown side effects that may occur after approval.
False
What is the definition “contract research organization” according to FDA’s IND regulations?
A person working with the sponsor as an independent contractor who assumes one or more of the obligations of the sponsor
What statement must the label of all investigational drugs bear?
“Caution: New Drug- Limited by Federal (or United States) Law to Investigational Use”
What type of experiences does the FDA classify as serious adverse experiences in clinical trials?
Any event that results in death
A life threatening drug experience
In patient hospitalization
What should be included on the title page of an investigator’s brochure?
Sponsor’s name
The identity of each investigational product
Release date
Within the IB’s summary section, the pharmacological and toxicological information that is relevant to the stage of clinical development of the investigational product are the only necessary elements to include .
False
:
The summary section must include
Pharmacological
Toxicological
Pharmacokinetic
Metabolic
clinical information available that is relevant to the stage of clinical development of the investigational product
The Investigator’s Brochure is not a required component of an original IND submission.
False
The FDA criterion which classifies an adverse drug experience as unexpected includes any adverse experience which is not consistent with the IB, or other designated document when an IB is not required
True
According to ICH GCP which document should be retained to document compliance with applicable labeling regulations?
sample of labels
According to ICH GCP which document demonstrates that the investigator is informed in a timely manner of relevant information as it becomes available?
investigator’s brochure updates
According to ICH GCP which documents document the existence of the subject and substantiate integrity of trial data collected?
source documents
According to ICH GCP which document permits identification of all subjects enrolled in the trial in case follow-up is required?
subject identification code list
What is the purpose of the 1572 form?
To provide information to the sponsor about investigators qualifications
It is an agreement by the investigator to conduct the study in accordance with relevant FDA regulations
If a study is not conducted under an IND (e.g., foreign studies or devices studies) is a 1572 required?
no
According to FDA guidance on the 1572 form how often should the investigator’s CV be updated during an IND study?
It does not need to be updated
Study drug dosing is 2mg/kg once daily. Patient’s weight at time of screening was 50kg and Cycle 1/Day 1 weight was 52 kg. Per protocol dosing calculation is based on subjects weight at time of screening.
What is the correct daily dosage for this subject?
100 mg QD
Dr. Smith is conducting a study for Miracle Pharmaceuticals. They hold the IND and provide the study drug. Dr. Smith provided advice in developing the protocol.
Dr. Smith is a(n):
investigator
