Be A CRA

Design, manage and maintain clinical trials.

The Certified Clinical Research Associate (CCRA) program, offered by McMaster University Continuing Education and affiliated with the Faculty of Health Sciences, is designed to develop the concepts, skills, strategies, attitudes and knowledge required to perform clinical trials.

A CCRA is an individual who functions as administrator, coordinator, consultant, educator, and/or researcher in the management of clinical trials. A CCRA will acquire skills in the administration and progress of a clinical trial while understanding the ethical and legal ramifications for all participants. This covers protocol development, data collection, analysis, monitoring, recording, auditing, ethics and regulations, liabilities and responsibilities of conducting research with human subjects.

Program objectives

Students will

gain knowledge of the Canadian health care system, health care legislation, procedures and practices for regulating the development of health care products
be able to critique a journal article and rate the evidence level
be able to formulate a clinical development plan, ensure clinical trial data is credible and accurate and that the rights, integrity and confidentiality of trial subjects are protected
gain an understanding of the challenges and limitations of implementing and maintaining databases

Who should take this program

professionals from a variety of academic backgrounds, including health sciences, medicine, nursing, health informatics, or epidemiology

Program delivery format

in class, evenings, on the main McMaster campus

Courses

276-003 Clinical Trial Methodologies in Practice (3 Units)

A series of workshops explains clinical research designs, clinical outcomes and measurement tools, with real life illustrations, including a module on consent forms, and sessions on compiling a protocol and developing the ideal questionnaire. Study management will be demonstrated by reviewing a mock clinical trial protocol review and auditing by a pharmaceutical company representative.

Prerequisite: It is suggested that this course be taken last.

276-001 Clinical Trial Research Coordinator (3 Units)

This course will prepare you to assume the duties of managing and organizing a clinical trial. The nuts and bolts of running a trial, getting ready for a pharmaceutical company audit, understanding the standards and regulations that affect conducting clinical trials in Canada, and a basic understanding of ethical principles and data organization are covered in a series of workshops. The practical component consists of two preceptorships with experienced clinical trial researchers in different clinical areas.

276-005 Critical Analysis & Advancement of Writing & Communication Skills (3 Units)

This practical lecture and workshop series examines the optimal strategies to improve writing and communication skills. The course focuses on enhancing your interpersonal communication skills by developing active listening and interviewing strategies. Organizational dynamics, conflict resolution and negotiation strategies in the context of dealing with internal and external parties involved in a clinical trial will be discussed in a workshop style. Students will develop their presentation skills by participating in class presentations. Basic grant-writing skills will be taught with hands-on sessions using real protocols. A critical analysis sensitivity will be developed by discussing the critical components of publications in general and how to best present your data.

276-002 Research Ethics & Regulatory Affairs (3 Units)

This course will provide an understanding of the ethical guidelines, issues and challenges of conducting research on human subjects. Special rights and concerns of participants will be explored. Students will understand and learn how to cope with conflicts of interest and will discuss challenging case scenarios like genetic testing, limits of confidentiality and the meaning of minimal risk. Health care legislation, guidelines, and regulatory and research contractual issues will be covered in the context of protecting all research parties and explaining their rights and liabilities. The format will be a series of lectures and small group workshops using a problem-based approach to learning.

276-004 Statistics, Databases & the Internet in Clinical Research (3 Units)

This course is designed to familiarize you with basic biostatistical concepts and methods required in the development and implementation of a clinical trial and the analysis and interpretation of data. New and improved hardware and software packages are constantly being churned out, making it harder to choose the appropriate one for your purposes. Setting up databases, maintaining and manipulating them as well as using the Internet effectively to conduct searches and collect relevant information will be taught in a module format.

Certified Clinical Research Associate Certificate Requirements

To earn a certificate, students must complete the following five courses (15 units). Students enrolled in the CCRA program will receive an email notification outlining when CCE is accepting registrations for the upcoming term. This will be sent 2 weeks prior to the opening of registration each semester.

*Please note that 276-001 acts as a prerequisite for all other courses in the program. Students may take courses concurrently with 276-001; 276-003 should be taken last. Remaining courses can be taken in any order.

All courses are required.

276-001 Clinical Trial Research Coordinator (3 units)
276-002 Research Ethics & Regulatory Affairs (3 units)
276-003 Clinical Trial Methodologies in Practice (3 units)
276-004 Statistics, Databases & the Internet in Clinical Research (3 units)
276-005 Critical Analysis & Advancement of Writing & Communication Skills (3 units)

Admission Requirements & Application Procedure

Certified Clinical Research Associate	Certificate
At least five years of clinical experience, health care teaching, administration or research
An up-to-date Curriculum Vitae
Completed CCRA Application Package*
$79 non-refundable application fee

Application Information

Applications are accepted for each term (Fall, Winter, Spring) and are approved on a first come first serve basis. Please note enrolment is limited.

All approved new students starting the program will be reserved a spot in the first course (Pre-requisite) 276-001 Clinical Trial Research Co-ordinator for the term they wish to start.

Applicants who have completed a Bachelor degree or who are currently enrolled in a degree program will be given preference.

Send the program application package to:

Cathy Emick
McMaster University
Centre for Continuing Education
Downtown Centre, 2nd Floor
1280 Main Street West
Hamilton, ON L8S 4L8

Transfer of Credit Option

Courses completed at other post-secondary educational institutions may be eligible for transfer of credit. Application for transfer of credit must be made to the Program Manager.

The following conditions apply:

Courses must have an 80% overlap in content/curricula and a similar number of classroom hours;
Courses must be listed on an official transcript with a grade;
Courses must have been taken within the last five years.

Each course that is accepted into the program will be assessed a $79 transfer of credit fee (excluding CCRA courses taken through Mohawk College). The Certificate accepts only one transfer (excluding CCRA courses taken through Mohawk College). Students transferring courses from Mohawk are not eligible to transfer in other external courses.

Getting Started

Can you review my documents to see if I am eligible for admission before I submit my application?

Program staff will review only the documents submitted as part of an application package.

Do I need to pay the application fee if I am not accepted to the program?

The application fee is applied to all applications received by the Centre for Continuing Education. There are no refunds for the application fee.

I see there is an application process, how long will it take to receive a response?

Depending on when the application is received, applicants can expect to receive a response within 2-3 weeks.

How do I get my textbooks and other course materials?

Course materials may be purchased at the Campus Store (main campus) or order textbooks online and have them shipped.

What if English is not my first language?

Please see the English Language Proficiency Requirements.

What tuition support options are available?

Centre for Continuing Education does not offer any financial aid or bursaries. Our programs are considered to be part-time and are therefore not eligible of OSAP funding. Students may inquire with Student Financial Aid & Scholarships Office at McMaster (ext. 24319). Many companies encourage their employees to continue their education through tuition assistance programs. Ask your HR office or your supervisor if you qualify.

How long does it take to complete this program

Program completion depends on student’s own pace and availability of courses. All of our programs are considered part-time. Students can take as many courses as they like in a given semester, so long as any posted pre-requisites are satisfied. It is possible to complete the certificate in one year, but some students prefer to take more time.

What is a MAC ID?

MAC ID is a unique, common identifier enabling single sign-on for a number of McMaster systems and applications (including registering online for Centre for Continuing Education courses).
Your MAC ID is not your McMaster employee or student number. To activate your MAC ID, you will need your student number, barcode and date of birth.
First time students will receive their barcode number and student number via email from the University approximately 1 week after registering for their first course.
Your barcode and student number can also be found on your student ID card (students taking courses online will not receive a student card). Follow the step by step instructions below and be certain to make sure your password meets the designated criteria. If you have questions, please call Centre for Continuing Education at (905) 525-9140 ext. 24321.

Go to MUGSI

Enter Student Number, Barcode Number and Date of Birth

Accept Terms and Conditions Create Password

For security purposes, submit 3 Questions with Answers

Activation Complete Completing the activation process instantly provides you with a MAC ID

What is MUGSI?

MUGSI , (McMaster University Gateway to Student Information), is an intranet site that allows McMaster students to view and change their personalized information, view grades and print tax receipts. In order to access MUGSI, you need to activate your MAC ID.

How do I get my student card?

All student cards are sent out by the Registrar’s Office along with the term’s sticker. Cards will only be sent to first-time students; stickers are sent to returning students. If students have not received a student card or a sticker, contact the Registrar’s Office at 905.525.9140 ext. 24796

I have completed similar courses at another institution. How do I apply for transfer credits?

To be eligible, students need to be currently enrolled in the CCE program and submit a cover letter that maps out what you have completed, where and what course you would like the credit applied towards (i.e. Marketing 123 completed at University of Toronto, in place of 570-819 Marketing), an official transcript with marks.
Students must submit a course outline to ensure that the course content is at least 80% comparable to our Centre for Continuing Education course.
Please note that only courses in which a minimum grade of C- has been achieved may be considered for a transfer of credit. Also, courses completed longer than 5 years at time of application may not be considered. There is a fee of $79 for each TOC (once approved by the Program Manager). The price is subject to change.
Your McMaster transcript will NOT show the actual details of the TOC. Students will receive a letter from the Centre for Continuing Education confirming the TOC has been granted which the students should keep for their own personal records. TOC is not view-able for the students on MUGSI.

What is a unit?

Units define the number of credits associated with a course. Units are assigned by the University based on course content and hours of instruction. Centre for Continuing Education courses range from one to three units. 3 units is equivalent to a half-year undergraduate course.

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