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Clinical Trials Research Administration 101 Certificate
About CTRA 101
The Clinical Trials Research Administration ("CTRA") series delivers intensive training sessions specifically designed to provide an understanding of the critical elements of successful administration of a clinical trials research program. The program currently has two levels of progressively complex training that must be taken in succession, CTRA 101 then CTRA 201. Each level introduces the student to a curriculum presenting the body of knowledge required to perform as an accomplished clinical trials research administrator. Satisfying the requirements of the CTRA 101 certificate, or testing out of the CTRA 101 certificate via an advanced placement test, is required prior to taking CTRA 201. Testing out of CTRA 101 will not provide the member with a CTRA 101 certificate.
The CTRA series examines issues relevant to both National Institutes of Health-sponsored and industry-sponsored clinical trials. Much of the material is explored through case studies. Elements of the curriculum include protocol review, recruitment, negotiation of agreements, development and negotiation of budgets, compliance, billing, international studies, and risk management and analysis. These elements, along with other relevant issues, will be presented in a combination of one full-day workshop and four sessions for each program.
Register for the CTRA101 Advanced Placement Test
Register Online
$30 administrative fee. Only Members may view.
Testing out of CTRA 101 will not provide the member with a CTRA 101 certificate. You must receive 70% or above to pass the test. If you do not pass the test, you will be ineligible to take it again and must complete the requirements of the Clinical Trials Research Administration 101 Certificate in order to go to the 201 level.
You will have one hour to complete an online assessment. Once you have completed registration, please e-mail npotter@srainternational.org for your test link.
CTRA 101 Certificate Program Requirements
CTRA 101 is comprised of one full-day workshop, two required sessions and two elective sessions. The required courses are listed below; the electives will vary meeting-to-meeting.
Required Workshop (full-day)
- A Guide to Clinical Trials Administration
Required Sessions (must take two)
- Clinical Trials: The Industry Perspective
- Negotiating Clinical Trial Agreements with For-Profit Companies
Elective Sessions (must take two)
Electives vary from meeting to meeting
About the Certificate Tracking Booklet
The tracking booklet allows members to easily record their progress. Obtain a stamp at the conclusion of each workshop or session. Once all coursework has been completed turn in your documentation to the Registration Desk at the meeting or e-mail it to Certificates@srainternational.org to receive your certificate of completion. If you attended a workshop or session at a previous SRA meeting, list the meeting on the line next to the course. SRA staff will verify your attendance at previous meetings. The blank lines under electives are for future meetings where new sessions may be held.
Courses given over the past three years (Fall 2009 - Fall 2012)
2012 Annual Meeting - Orlando, FL
Required Workshops
Guide to Clinical Trials Administration
Required Sessions
Negotiating Clinical Trial Agreements with For-Profit Companies
Clinical Trials: The Industry Perspective
Elective Sessions
Responsible Conduct of Research (RCR) for Research Administrators
Human Subjects Research and Non-Compliance
Clinical Trials and Research Grants: Diverging Trails
Biological Specimens in Industry Sponsored Research
Anatomy of a U-Grant: Practical Tips and Guides
2012 Midwest/Southern Section Meeting - Cincinnati, OH
Workshop
A Guide to Clinical Trials Administration
Required Sessions
Clinical Trials: The Industry Perspective
Negotiating Clinical Trial Agreements with For-Profit Companies
Electives
Biobanking for Research and Clinical Trials
Clinical Trials Panel: Learn From For-Profits and the Nonprofits
Contracts, Budgets and Financial Management: A Clinical Trials Office Perspective
2012 Western/Northeast Section Meeting - San Francisco, CA
Electives
Understanding the Various Types of IRB Review
From the Ground Up… Building a Viable Hospital-Based Clinical Trials Program
2011 Annual Meeting - Montréal, Canada
Workshop
A Guide to Clinical Trials Administration
Required Sessions
Clinical Trials: The Industry Perspective
Negotiating Clinical Trial Agreements with For-Profit Companies
Electives
Effective Budgeting and Contract Negotiations for Clinical Trials
BioBanking Basics: An Overview of Current Legal and Compliance Issues Related to Human Specimens Collected in Research
The FDA is Coming - How Will You Coordinate With Your Sponsor
Addressing Subject Injury: Informed Consent, Contract Language and the Interplay with Third Party Payers
Human Research Protection Program: Beyond the IRB
2011 WE/MW - Long Beach, CA
Workshop
A Guide to Clinical Trials Administration
2010 Annual Meeting - Chicago, IL
Workshop
A Guide to Clinical Trials Administration
Electives
Ethical Issues in International Human Research Protections
Taming the Billing Beast: How to Better Manage Clinical Trial Budgets
Reimbursement to Subject Enrolled in Clinical Research Studies
Human Subject Protection: A Collaborative Approach
Coverage Analysis For Clinical Trials: What Is It and Why Is It Important?
2010 NE/MW - Philadelphia, PA
Workshop
A Guide to Clinical Trials Administration
Required Sessions
Clinical Trials: The Industry Perspective
Negotiating Clinical Trial Agreements with For-Profit Companies
Electives
Good Clinical Practice (GCP) and the IRB
Shades of Gray - Determining What is and is not Human Subject Research
What Research Administrators Need to Know About Complying with Human Research Protections
2009 Annual Meeting - Seattle, WA
Workshop
A Guide to Clinical Trials Administration
Electives
Ethical Issues in International Human Research Protections
OLAW Update
OHRP Update
Shades of Gray - Determining What is and is not Human Subject Research
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