You have been given the product description and sample study below for a new
assay to detect cervical cancer. Your assignment is to draft a report of prior
investigations (ROPI) section of an Investigational Device Exemption (IDE)
Case Study 2
You have been given the information below for a new product to aid in the individualization of
chemotherapy for advanced (Stage III-IV) non-small-cell lung cancer. Your assignment is to draft a
clinical study protocol for submission to FDA. Y
0 out of 3 points
Based on the following information, the Risk Priority Index would be _. (xx.x)
Occurrence = 3
Confidence Level = 0.5
Severity = 5
Detection = 6
Occurence, Severity, Detection
The protocol template is a tool to facilitate rapid protocol development. It is not intended to
supersede the role of the Protocol Chair in the authoring and scientific development of the
protocol. It contains the boilerplate languag
CHECKLIST FOR WRITING AN
INFORMED CONSENT DOCUMENT
Protocol: _ Sponsor: _
Protocol Version (No. and/or Date):
Consent Form Version (No. and/or Date): _
Participating Site: _
Name of the Study: Cancer Targeted Gene Panel Therapy
Name of the Principal Inv
1. The _ _ Act requires licensing and manufacturer inspections
and premarket approval of vaccines, serums and antitoxins.
Biological Control Act
1. Under the _ _ Amendments, Companies for the
first time were required to dem
410.649.82 - Introduction to Regulatory Affairs Quiz 2
Due: Sunday, November 1st 11:59 p.m.
Please be concise in your responses (use 1 spacing with 1 margins)
Please submit this assignment through Turn-it-in using the previously stated naming
AS.410.683.82 Introduction to cGMP Compliance
Instructions: Answer the following 7 questions on how to use 21 CFR.
Example: What is the title of 21 CFR?
Food and Drugs
Example: What is the title of 21 CFR 210.3?
1. What is th
Test 1 c Intro to cGMP
1. Which of the following is NOT discussed in 21 CFR?
Good Clinical Practices (GCP)
Computer system validation
ISO 9001: Quality Management Systems
1. The FDA was founded
Food and Drug Law Chi
This exam is open book but not a group assignment. It is due at midnight, Tuesday, March 1,
2016 Washington, DC time. Late submissions will not be accepted.
For the brief answers section, use
Example of a Context of Use in a Qualification Recommendation for Hypothetical
This document provides an example of a Context of Use (COU) for a hypothetical biomarker that
is qualified through the Biomarker Qualification Program (BQ
SAMPLE REPORT OF PRIOR INVESTIGATIONS
2.1.1 Overview of the Ankle Joint
The motion and biomechanics of ankle the joint differs from
those of the knee and hip joints.6,23 The ankle joint consists of three
articulating surfaces: (1) the dis