WELCOME!!
RC-4 - Overview of Clinical Site Operations and Management
Dear Clinical Research Coordinator Students,
Welcome back to the UAB PERC Research Coordination Certification Course. This final course is combining
extra units for a total of 30 CEUs! By now you have successfully completed RC-1 “Overview of Teaching
Strategies for Clinical Research Coordinators and Healthcare Professionals”, RC-2 “Overview of Historical,
Ethical and Cultural Issues in Clinical Research” (15 CEUs) and RC-3 “Overview of Research Methods and
Regulatory Processes in Clinical Research” (15 CEUs). This next course, RC-4 is entitled “Overview of
Clinical Site Operations and Management”. As stated in my prior letters to you, RC-4 will focus on clinical
trial protocol development, roles of sponsors, recruitment and informed consenting. This is setting the stage for
determining what protocols will be done. Consider how sponsors determine protocol and site selection.
Consider the reasons your site decided to conduct specific studies and the plans the site has for the future. Is
reputation alone the determinant for site selection or are there other ongoing factors that highlight a site as a
benchmarking site? You will look at the drug and device development processes from the perspective of
industry and regulatory bodies to launch your journey into understanding the process from those perspectives.
Taking a look at the “business” and “regulatory” aspects of launching a study, including the all-important
budget development and contract negotiation shifts to the institutional perspective. We will start with a
regulatory focus on the process of Informed Consent and in later Units will review data management, quality
assurance, monitoring, adherence and site/team organization and functions. All Units are designed to support
the next. Therefore, the focus of this course RC-4 is to pull it all together using a hands-on approach to systems
organization, team building and quality assurance.
We have been most impressed with the discussion forums that have taken place in the prior courses. Continue
high level discussions in this upcoming course. Indeed, you are encouraged to share your personal research and
site experiences in applying this content to your own sites with the class through VISTA discussions and chat
rooms. Participation in discussions is required for each Unit. A pre-test will be taken by each student prior to
initiating the course Unit. A post-test will be given at the completion of the Unit. It continues to be important
to stay organized and follow the calendar timelines. A checklist of learning activities and assignment deadlines
is provided within the Topical Outline to aid in time management. Let us know if you have any time issues. I
1
1010F School of Nursing Building
1701 University Boulevard
Birmingham, AL 35294-1210
www.uab.edu/son
The University of
Alabama at Birmingham
Mailing Address:
NB 1010F
1530 3RD AVE S
BIRMINGHAM AL 35294-1210
have included several written assignments in this last course so it is important to stay up to date.
Instructions for the Module Folders: You will be provided textbooks, handouts and a CD-ROM. When you
open your CD, you will find a menu that lists all of the contents, beginning with the introductory syllabus, then
progressing through Modules labeled as “A”, “B”, and “C”. You will see that CD-ROM files are numbered to
assist in going through materials in order. Simply click on the file name in the menu and the file for that
module will open. All modules include a module syllabus, checklist, lecture notes, journal articles and voice
narrated PowerPoint presentations. Your handouts are hard copies of the module materials. Each module
includes a list of required readings, learning assignments and discussion topics. Additional readings are
provided for your information or continued study, but are not required to be read.
Instructions for BlackBoard/VISTA: You can access the course by logging into
www.uab.edu/trainingcourses - then simply use your user ID and password to log in and select your course.
Course materials and discussion platforms are designed similarly to RC-1 and RC-2.
Course Faculty: As with all PERC courses, you will be facilitated by the three course faculty listed below.
Students will complete discussion assignments within one of three assigned groups. We look forward to
working with you in this course. If you have questions, please email us through the Blackboard/VISTA E-mail
platform. We will make every attempt to address your E-mails within 72 hours!
Carolynn Thomas Jones, MSPH, RN
Cynthia Joiner, MPH, RN
Jennifer LaBorde, MN, RN
Facilitating this course is a wonderful pleasure. The PERC Team looks forward to another session with you all!
Sincerely,
Carolynn Jones
Carolynn Thomas Jones, MSPH, RN
Faculty Instructor
School of Nursing
University of Alabama at Birmingham
cjthomas@uab.edu
2
1010F School of Nursing Building
1701 University Boulevard
Birmingham, AL 35294-1210
www.uab.edu/son
The University of
Alabama at Birmingham
Mailing Address:
NB 1010F
1530 3RD AVE S
BIRMINGHAM AL 35294-1210