**Disclaimer**

This syllabus is to be used as a guideline only. The information provided is a summary of topics to be covered in the class.
Information contained in this document such as assignments, grading scales, due dates, office hours, required books and materials may be from
a previous semester and are subject to change. Please refer to your instructor for the most recent version of the syllabus.

HCR563 – Fundamentals of Regulatory Affairs

Arizona State University
College of Nursing and Health Innovation
Clinical Research Management Graduate Program

Course: HCR563 – Fundamentals of Regulatory Affairs

Course Abbreviation: Regulatory Affairs
Course Address: http://myasucourses.asu.edu

Faculty: Debra M King, M.S.

Instructor
Clinical Research Management Graduate Program
Phone/text: 520-345-7450
Email: dmking12@asu.edu

JoAnn Pfeiffer, DrSC, RAC, CCRA

Director
Clinical Research Management Program
Office: 602-496-0547
Email: jpfeiff4@asu.edu

Office Hours: The instructors’ preferred method of contact is via ASU email. You can expect a
response within 24 hours. On weekends or holidays, it may be longer.
Virtual Office Hours (Online or Telephone Chat):
By Appointment, arrange with Ms. King or Dr. Pfeiffer via email

Semester: Summer 2018 (16May2018-10Jul2018) Session C

Pre/Co requisites: Admission to the Graduate Program or by permission of instructor

Credit Hours: 3 credit hours

Course Modality: Course is offered in an online, asynchronous format using Blackboard learning
management system. Student learning is demonstrated through discussion
forums, interactive modules, course readings (online and textbook), individual
projects, examinations, and self-study.

Catalog Description: Principles of Regulatory Affairs and an overview of the role of ethical clinical
research in new product development. Key regulations that relate to medical
product safety, their origins, and applications. Preparation of documentation for th
review of medical products throughout the product lifecycle.

Course Overview: The focus of this course is on the role of clinical research and the regulatory
process for new medical products. The course will cover the origins and current
status of laws and regulations as they pertain to the development, testing,
commercialization, and total product life cycle for medical products. Students will
also explore regulations that govern the conduct of clinical research, including

1 of 15
 study sponsors, investigators, and Institutional Review Boards. The students will
review submission documents that are required for regulated products.

Course Outcomes: Upon completion of this course, students will be able to:

1. Appraise the US and International Regulatory

Systems and Agencies governing the
commercialization of medical products and the
conduct of clinical trials.
2. Analyze the structure of the Food and Drug
Administration (FDA) and the functions of each
major component of the organization.
3. Evaluate the regulatory impact of the US Consumer
Product Safety Commission (CPSC), EPA, OSHA
and state and local authorities, and the FCC and
the FTC.
4. Investigate the consequences of failure to comply
with regulatory policies.
5. Compare and contrast the types of approvals and
characteristics of each pathway for regulated
products.
6. Analyze the importance of audits and the
inspectional process and the subsequent reporting
requirements.
7. Explain the role of FDA Advisory Committees in the
review of products and in Agency policy decisions.

EPortfolios: Students in the CRM program are required to create an ePortfolio. As part
of the course work, students will complete a reflection assignment in the
ePortfolio for each course they take. Students will set up their ePortolio in
their first course of the CRM Program

Technological Expectations: Students are expected to:

□ Have access to consistent computer/tablet/mobile devices and

internet throughout the term of the class.
□ Have access to computer/tablet/mobile device with microphone
and speaker for optional web conferences. (Headsets are
available for less than $10 at most electronic stores.)
□ Access and use email for communication.
□ Use the Blackboard Learning Management system.
□ Submit quality electronic documents using software for
spreadsheets, presentations, and manuscript creation. Examples
of software include: Microsoft Office, Adobe Acrobat, etc.
□ Exchange documents with faculty and classmates using BlackBoard.
□ Use internet and literature search strategies to access
appropriate and relevant literature.
□ Use a software program to APA-format papers.

2 of 15
□ Use multi-media software for voice over internet protocol (VOIP)
with PowerPoint/web or POD casting or teleconferencing.

3 of 15
 2018 New Student Computer Requirements

Minimum Hardware & Software Requirements

It is recommended that you have a laptop computer that meets at least the following specifications.

Windows Computer
Operating System MS Windows 8
MS Windows 10

Processor Intel® CoreTM i5 Processor or higher

Memory 4 GB RAM

Network Adapter 100 BASE-T Ethernet (important)

802.11 n/ac wireless network access (required)

Screen Resolution 1920 x 1080 (minimum)

Web Browsers Microsoft Internet Explorer 10 or higheri

Mozilla Firefox (current stable
release)ii Google Chrome (current
stable release)iii

Other Software Microsoft Office 2016 or Office 365

Adobe Acrobat Reader (current
version)iv Adobe Flash Player
(current version)v
Java Runtime Environment (current
version)vi Apple QuickTime (current
version)vii

Apple Computer
Operating System Mac OS X 10.11 and above

Processor Intel® CoreTM i5 Processor or higher

Memory 4 GB RAM

Network Adapter Built-in AirPort Extreme Wi-Fi wireless networking

(required) Built-in 10/100/1000BASE-T Gigabit Ethernet
(important)

Screen Resolution 1280 x 800 (minimum)

Web Browsers Apple Safari 10 or higher

Mozilla Firefox (current stable release)2
Google Chrome (current stable release)3

4 of 15
Other Software Microsoft Office 2016 or Office 365
Adobe Acrobat Reader (current version)4
Adobe Flash Player (current version)5
Java Runtime Environment (current version)6
Apple QuickTime (current version)7

Computer Hardware & Software Issues

We have discovered that some of the software packages and resources you will need to access for
this program will not run on certain computers and devices. This includes (but is not limited to):
□ Google Chromebook
□ Apple iPad
□ Android Tablets
□ Microsoft Surface Tablets

5 of 15
Classroom Policies: This is a graduate level class that requires students to be fully engaged.
As such, the following policies are guidance for minimal performance.
1. Login to Blackboard at least every 4 days and read announcements
as well as class content. Students who do not login over a 7-day
period without contact with the instructor will be in danger of failing
the course.
2. Check email regularly for course-related information.
3. Complete assignments on time – incomplete assignments are not
an option.
4. No late assignments unless given prior approval by course
instructor.
5. Assignments, tests, and final exams are due by 11:59 pm (AZ
time) Friday evenings. Initial discussion board posts are due
by 11:59 PM (AZ time) Wednesdays; final posts are due by
11:59 PM (AZ time) Saturdays.
6. Monitor grade book to access and acknowledge course feedback.
7. Communicate with faculty within current week if there are problems
with the course content, understanding, and/or other issues.
8. Reading and homework assignments will average 5-15 hours per
week.
9. Keep current with assignments and homework (to ensure that
student does not fall behind).

Textbook(s): The textbook for this class is:

Mantus, D. & Pisano, D. J. (2014) FDA regulatory affairs, (3rd Ed.) CRC Press.
ISBN 9781841849195- CAT# HE10486.

You may order this book through the Bookstore, the publisher’s website
(http://www.crcpress.com/product/isbn/9781841849195) or you may choose to order
from a vendor of your choice. Some vendors are: Amazon.com, Half.com,
textbooks.com, follett.com, etc. While the choice of book vendors is yours, please note
that use of the text is essential to your success in the course. We are using the most
current version of the text, the 3rd edition, which was released in 2014. Use of a
previous edition is not advisable; all tests, assignments and discussions are based on
the 3rd edition. The book is also available in electronic format and can be rented in that
format as an alternative to purchasing the book.

Evaluation Methods:
Critical thinking is demonstrated through class participation in discussion forums and
through written work and examinations. Students prepare for class discussion through
readings, accessing the Internet, and other resources and through email communication
with faculty and classmates. A combination of quizzes and exams, written papers or
projects and online assignments are used to determine course grade.

6 of 15
 • 3 discussion boards worth 25 points each for a total of 75 points (7.5%)
• 3 assignments worth 125 points each for a total of 375 points (37.5 %)
• 3 exams worth 150 points each for a total of 450 points (45%)
• One reflection exercise worth 100 points (10%).

Grading Policy for CONHI:

Clinical Research Management Program grading guidelines allow for a C in individual
course/assignments (D or lower is considered failing and the student will be required to retake
the course). An overall GPA of 3.0 is required in graduate certificate and Masters programs.
Students whose overall GPA falls below 3.0 are considered to be on probation and are in
danger of failure

Grading Matrix:

Grade Percentage Number of Points* Grade Point

A 90% or more 900+ 4.0

B 80% to less than 90% 800 – 899 3.0

C 70% to less than 80% 700 - 799 2.0

60% to less than 70%

D 600 - 699 1.0
course repeat

E <60% course repeat <600 0.00

Course Topics and assignments are listed in the table, below.

Reading assignments and additional materials will be posted on Blackboard.

Late or Missed Assignments
Notify the instructor as soon as possible, BEFORE an assignment is due if an urgent situation arises
and the assignment will not be submitted on time. Published assignment due dates (Arizona
Mountain Standard time) are firm.

Late Assignment Policy: A 10% penalty per day for up to 7 days will be applied to late
assignments that do not have prior instructor approval for an extension. Assignments will not
be accepted after 7 days.

Accommodations: Please follow the appropriate University policies to request an accommodation

for religious practices (http://www.asu.edu/aad/manuals/acd/acd304-04.html) or to accommodate a
missed assignment due to University-sanctioned activities
(http://www.asu.edu/aad/manuals/acd/acd304-02.html).

7 of 15
Course Assignments and Grading:
Initial Responses are due
Wednesdays by 11:59PM (AZ Time)
2 Peer Responses are due
Saturdays by 11:59PM (AZ Time)
Postings of DB will not be accepted
after Saturdays.
Assignments 1, 2 & 3 are due on
Sundays by 11:59 PM (AZ Time)
Test 1 and MidTerm are due
Fridays by 11:59 PM (AZ Time)
Final Exam
Due by 11:59PM (AZ Time) on 10Jul

Course Calendar
Start
Class Topic/Assignment Due Date
Date
Introduction
Acknowledge Academic Integrity Statement
Comparison between Office for Human Research DB1
Protection (OHRP) & Food and Drug Administration First Post
1 16May (FDA) authorities; Context to study Regulatory Affairs 18 May
(Course Outcomes 1 & 2) Responses due
Introduction and Discussion Board 1 20 May
Since this is a short week, discussion post is due on
Friday and responses on Sunday.
History of FDA Laws and FDA Organization Assignment 1
Drug Development 28 May
2 21May
(Course Outcomes 2 & 5) (extra day due to
Assignment 1 holiday)
DB 2
Regulation of Medical Devices, Quality System First post
Regulations and Medical Device Submissions 30 May
3 28May (Course Outcome 5) Final post
Discussion Board 2 02Jun
Test 1 Test 1
01Jun
Regulation of Pharmaceuticals
Regulatory Submissions for Drug Products Assignment 2
4 04Jun
(Course Outcome 5) 10Jun
Assignment 2
Good Clinical Practices (GCPs), the Institutional DB 3
5 11Jun Review Board (IRB) and Adverse Event (AE) Reporting First post
FDA Advisory Committees 13Jun
8

8 of 15
 (Course Outcome 7) Final post
Discussion Board 3 16Jun
Midterm Exam Midterm
15Jun
Regulation of Diagnostics, Biologics, Food,
Supplements, etc. Assignment 3
6 18Jun
(Course Outcomes 2 & 5) 24Jun
Assignment 3
DB 4
First post
FDA Site Audits / Investigations
27Jun
(Course Outcomes 4 & 6)
7 25Jun Final post
Discussion Board 4
30Jun
Final Exam
10Jul
International Regulations, Other US Regulatory Reflection
Entities (Course Outcome 3) Assignment
8 02Jul EPortfolio Reflection 09Jul
Final Exam Final Exam
10Jul

Summary of Graded Assignments

Grading
Assignments, Quizzes & Exams Points Due Date

Initial Post – Pfeiffer

Introduction and 18 May
25
Discussion Board 1 Responses
20 May
King
Assignment 1 125 28 May

Pfeiffer
Discussion Board 2 – First Post 15 30 May

Pfeiffer
Discussion Board 2 – Peer Posts 10 02 Jun

King
Test 1 125 03 Jun

King
Assignment 2 100 10 Jun

Pfeiffer
Discussion Board 3 – First Post 15 13 Jun

9 of 15
 Pfeiffer
Discussion Board 3 – Peer Posts 10 16 Jun

Midterm King
150 15 Jun

King
Assignment 3 100 24 Jun

Pfeiffer
Discussion Board 4-First Post 15 27 Jun

Pfeiffer
Discussion Board 4-Peer Posts 10 30 Jun

King
Course Reflection Exercise 100 09 Jul

King
Final Exam 200 10 Jul

Total possible points: 1000

Assignment Details:

• Discussion Boards: Discussion Boards are designed as a means of communication and class
participation. You are strongly encouraged to investigate the questions posed in the discussion board
and synthesize your opinions in postings.
o You are required to post an original post no later than Wednesday, midnight, for each week
that there is a discussion board assignment. You may post comments to your peers at any
time during the week up to the due date/time for that assignment, Saturday, midnight of the
week the DB post is due.
o You will be able to view your peers’ posts only after you have made your own initial, original
post.
• Discussion board entries are scored on a point continuum as follows:
o Full points (25) = substantive contribution to the discussion with at least one initial post and 3
replies to class colleagues, for every DB assignment that requires both an original post and
responses. The content should answer the questions thoughtfully identify the main points of
the issues, and should encourage further interaction by challenging, offering, or requesting
further elaboration on replies to other posts. Additionally, the post should demonstrate a
willingness to listen to and consider other viewpoints. Quality is based on data/evidence,
accuracy, precision, relevance and completeness.
o Partial points (<25) = tends to consist of non-substantive comments such as “I agree” or makes
minimal comments; only responds to one other post; summarizes rather than analyzes source
material and/or other posts; is confused or identifies a different or irrelevant issue;
misrepresents the issue or other posts; is self-contained with little or no reference to other
posts or sources; tends to express personal opinions and does not demonstrate a willingness to
10

10 of 15
 engage in a critical examination of alternative views; fails to establish other critical distinctions
among perspective and positions; repeats information provided, taking it as truth, or denies
evidence without adequate justification.
o No points (0) = Does not post or does not contribute anything to the discussion; addresses a
single source or view of the argument. Makes a bland general agreement statement that does
not provide additional substance to the discussion. Does not respond to any other posts within
the week for that forum.
o Student BB discussion forum entries are expected to be completed within the week of that
class. Postings of DB after Saturdays will not be accepted.

• Assignments: Please be sure that your assignments are submitted according to the schedule in the
assignment grid. Your written assignments are a communication exercise (an opportunity to work on
writing skills) as well as a way to improve your critical thinking skills. A grading rubric will be available
as a guide as you prepare your assignments. You are required to submit every assignment, test and
discussion board that is part of this course.

Detailed instructions and grading rubrics for the course assignments are posted on BlackBoard.

University Policies/Miscellaneous

Course Policies & Procedures

Online Course
This is a course that requires active participation in the online components of the course. Please note that
there are no face-to-face components and the course will be conducted using online technologies.

Communicating With the Instructors

This course uses a Blackboard™ discussion board called "Hallway Conversations" for general questions about
the course. Prior to posting a question, please check the syllabus, announcements, and existing posts. If you
do not find an answer, post your question. You are encouraged to respond to the questions of your
classmates.

If you have a question of a personal nature or a specific question about an assignment, please email the
instructor directly. You can expect a response within two business days.

Email and Internet

ASU email is an official means of communication among students, faculty, and staff
(http://www.asu.edu/aad/manuals/ssm/ssm107-03.html). Students are expected to read and act upon email
in a timely fashion. Students bear the responsibility of missed messages and should check their ASU-assigned
email regularly.

Per institutional policy, all instructor correspondence will be sent to your ASU email account.

11

11 of 15
Campus Network or Blackboard™ Outage
When access to Blackboard™ is not available for an extended period of time (greater than one entire evening)
you can reasonably expect that the due date for assignments will be changed to the next day (assignment still
due by 11:59pm).

If an outage occurs, it is expected that you will confirm that the outage is with the University and not your
local internet service provider. To monitor the status of campus networks and services, please visit the System
Health Portal (https://uto.asu.edu/system-health). If a system-wide ASU outage is NOT listed, you are
responsible for contacting the ASU Help Desk to report and troubleshoot the issue. By contacting the help
desk, a request case number will be created for you, which serves as an important documentation of your
attempt to resolve any technical problems in a timely fashion. You may be required to forward this
documentation to your instructor.

Course Time Commitment

Please expect to spend around 17-20 hours each week preparing for and actively engaging in this course.

Submitting Assignments
All assignments, unless otherwise announced, MUST be submitted to the designated area of Blackboard™. Do
not submit an assignment via other methods unless specifically directed or without advance notice to the
instructor.

Drop and Add Dates/Withdrawals

This course adheres to a set schedule and may be part of a sequenced program, therefore, there is a limited
timeline to drop or add the course (https://students.asu.edu/academic-calendar). Consult with your advisor
and notify your instructor to add or drop this course. If you are considering a withdrawal, review the following
ASU policies:

• Withdrawal from Classes (http://www.asu.edu/aad/manuals/ssm/ssm201-08.html)

• Medical/Compassionate Withdrawal (http://www.asu.edu/aad/manuals/ssm/ssm201-09.html)
• Grade of Incomplete (http://www.asu.edu/aad/manuals/ssm/ssm203-09.html)

Grade of Incomplete
Students must request a grade of Incomplete one week prior to the last day of the semester, but it is entirely
up to the instructor to approve the Incomplete. A grade of “I” can only be given by an instructor when a
student, who is doing otherwise acceptable work, is unable to complete a course (e.g., final exam or term
paper) because of illness or other conditions beyond the student’s control. The student and instructor must
complete a Request for Grade of Incomplete form.

The exact time frame for completion is negotiated between student and faculty however, students who
receive a grade of "I" in any course must complete course requirements within one calendar year of the
scheduled course and may NOT have longer than one calendar year. If a regular grade is not assigned within
the calendar year, the “I” becomes permanent part of the transcript. To repeat the course for credit students
must re-register and pay the required fees. The grade for the repeated course will appear on the transcript but

12

12 of 15
will not replace the permanent “I." Please see your program’s student handbook for the procedure for to
request an Incomplete.

Academic Status Reporting

An Academic Status Report (ASR) is a way for all faculty to provide early, personalized feedback regarding your
progress in a class. The feedback may provide either satisfactory or unsatisfactory progress being made. It is
not a part of your official transcript.

During the Fall and Spring semesters, there is one reporting period in Sessions A and B and two reporting
periods in Session C. Reporting periods are indicated on the Academic Calendar
(https://students.asu.edu/academic-calendar).

An ASR may include:

• Your current grade in the class

• A reason for the grade
• Recommendation for improvement

Grade Appeals
Grade disputes must first be addressed by discussing the situation with the instructor. If the dispute is not
resolved with the instructor, the student may appeal to the department chair per the University Policy for
Student Appeal Procedures on Grades (https://catalog.asu.edu/appeal).

Student Conduct and Academic Integrity

ASU expects and requires its students to act with honesty, integrity, and respect. Required behavior standards
are listed in the Student Code of Conduct and Student Disciplinary Procedures
(http://www.asu.edu/aad/manuals/ssm/ssm104-01.html), Computer, Internet, and Electronic
Communications policy (http://www.asu.edu/aad/manuals/acd/acd125.html), ASU Student Academic
Integrity Policy (http://provost.asu.edu/academicintegrity), and outlined by the Office of Student Rights &
Responsibilities (https://eoss.asu.edu/dos/srr). Anyone in violation of these policies is subject to sanctions.

Students are entitled to receive instruction free from interference by other members of the class
(http://www.asu.edu/aad/manuals/ssm/ssm104-02.html). An instructor may withdraw a student from the
course when the student's behavior disrupts the educational process per Instructor Withdrawal of a Student
for Disruptive Classroom Behavior (http://www.asu.edu/aad/manuals/ssm/ssm201-10.html).

Appropriate online behavior (also known as netiquette) is defined by the instructor and includes keeping
course discussion posts focused on the assigned topics. Students must maintain a cordial atmosphere and use
tact in expressing differences of opinion. Inappropriate discussion board posts may be deleted by the
instructor.

The Office of Student Rights and Responsibilities accepts incident

reports (https://eoss.asu.edu/dos/srr/filingreport) from students, faculty, staff, or other persons who believe
that a student or a student organization may have violated the Student Code of Conduct.

13

13 of 15
Title IX Statement
Title IX is a federal law that provides that no person be excluded on the basis of sex from participation in, be
denied benefits of, or be subjected to discrimination under any education program or activity. Both Title IX
and university policy make clear that sexual violence and harassment based on sex is prohibited. An individual
who believes they have been subjected to sexual violence or harassed on the basis of sex can seek support,
including counseling and academic support, from the university. If you or someone you know has been
harassed on the basis of sex or sexually assaulted, you can find information and resources at
https://sexualviolenceprevention.asu.edu/

College of Nursing and Health Innovation Student Handbook

Students are expected to adhere to the policies and guidelines in the current edition of the College of Nursing
and Health Innovation Student Handbook for your program (https://nursingandhealth.asu.edu/student-
life/current-students).

Prohibition of Commercial Note Taking Services

In accordance with ACD 304-06 Commercial Note Taking Services
(http://www.asu.edu/aad/manuals/acd/acd304-06.html), written permission must be secured from the
official instructor of the class in order to sell the instructor's oral communication in the form of notes. Notes
must have the note taker’s name as well as the instructor's name, the course number, and the date.

Course Evaluation
Students are expected to complete the course evaluation. The feedback provides valuable information to the
instructor and the college and is used to improve student learning. Students are notified when the online
evaluation form is available.

Syllabus Disclaimer
The syllabus is a statement of intent and serves as an implicit agreement between the instructor and the
student. Every effort will be made to avoid changing the course schedule but the possibility exists that
unforeseen events will make syllabus changes necessary. Please remember to check your ASU email and the
course site often.

Accessibility Statement
Disability Accommodations: Qualified students with disabilities who will require disability accommodations in
this class are encouraged to make their requests to me at the beginning of the semester either during office
hours or by appointment. Note: Prior to receiving disability accommodations, verification of eligibility from the
Disability Resource Center (DRC) is required. Disability information is confidential.

Establishing Eligibility for Disability Accommodations: Students who feel they will need disability
accommodations in this class but have not registered with the Disability Resource Center (DRC) should contact
DRC immediately. Students should contact the Disability Resource Center, campus-specific location and
contact information (https://eoss.asu.edu/drc/contactus) can be found on the DRC website. DRC offices are
open 8 a.m. to 5 p.m. Monday – Friday. Check the DRC website (http://eoss.asu.edu/drc) for eligibility and
documentation policies.

14

14 of 15
Email: DRC@asu.edu
DRC Phone: (480) 965-1234
DRC FAX: (480) 965-0441

Technical Requirements & Support

Computer Requirements
This course requires Internet access and the following:

• A web browser. Please use only Google Chrome (https://www.google.com/chrome) or Mozilla Firefox
(http://www.mozilla.org/en-US/firefox/new/)
• Adobe Acrobat Reader (http://get.adobe.com/reader/)
• Adobe Flash Player (http://get.adobe.com/flashplayer/)
• Microphone (optional) and speaker
• Upload Digication® electronic portfolio. Technical support available 24/7 through
https://asu.digication.com/home_guest.digi

Computer Skills Requirements

It is expected that you will be able to do at least the following tasks on a computer:

• Use the Blackboard™ Learning Management System (see

https://asu.secure.force.com/kb/articles/FAQ/Blackboard-Help-for-Students for assistance)
• Using ASU email
• Creating and submitting files in commonly used word processing program formats (specifically
Microsoft Word)
• Copying and pasting text
• Downloading and installing software
• Using spreadsheet programs (specifically Microsoft Excel)
• Using presentation and graphic programs

Technical Support
This course uses Blackboard™ to deliver course content. It can be accessed through MyASU
at http://my.asu.edu or the Blackboard™ home page at http://myasucourse.asu.edu/.

To monitor the status of campus networks and services, visit the System Health Portal
at https://uto.asu.edu/system-health or via Twitter by following @ASUOutages.

To contact the help desk you have two options:

• Website: assessed through the MyASU Service Center at http://my.asu.edu/service

• Chat: assessed through the MyASU Service Center at http://my.asu.edu/service
• Call toll-free at 1-855-278-5080

Copyright: Course content, including lectures and written materials distributed to the class, are under
copyright protection.

15

15 of 15