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Clinical Trials Research Administration Certificate
About CTRA 201
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.
To enroll in CTRA 201 please contact SRA's Nora Potter to verify you have previously taken CTRA 101 or to request the CTRA 101 advanced placement test (test requires a $30 administrative fee.)
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 201 Certificate Program Requirements
CTRA 201 is comprised of one full-day workshop, two required sessions and two elective sessions. The required courses are listed below; the electives may vary from meeting-to-meeting.
Required Workshop (full-day)
- Fundamentals of Human Research Protections
Required Sessions (must take two)
- Clinical Trials: Rules and More Rules
- Clinical Trials Budget Negotiation
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
Fundamentals of Human Subject Research
Required Sessions
Clinical Trials: Rules and More Rules
Clinical Trials Budget Negotiations
Elective Sessions
Making the Case for Clinical Trials Management System (CTMS)
Responsible Conduct of Research (RCR) for Research Administrators
Clinical Trials: Budgeting NIH Style
Prioritizing Clinical Research Resources: Development of a Centralized Research Support Core
Research Quality Assurance through Coverage Analysis: A Case Study
When Clinical Trials Close Before Completion
Research Administrator’s Healthcare Clubhouse
Clinical Research Consortia: Challenges and Lessons Learned Along the Way
Rebuilding a Research Ethics Committee
2012 Midwest/Southern Section Meeting - Cincinnati, OH
Workshop
Fundamentals of Human Research Protections
Required Sessions
Clinical Trials: Rules and More Rules
Clinical Trials Budget Negotiation
Electives
An Academic Site’s Foundation for Clinical Study Recruitment
Biobanking for Research and Clinical Trials
Clinical Trials Panel: Learn From For-Profits and the Nonprofits
The FDA is Coming: Who Will You Coordinate With Your Sponsor?
Contracts, Budgets and Financial Management: A Clinical Trials Office Perspective
Clinical Trial Agreements: The Other Contract Clauses
2012 Western/Northeast Section Meeting - San Francisco, CA
Electives
How to Negotiate and Utlize Master Clinical Trial Agreement
2011 Annual Meeting - Montréal, Canada
Electives
Effective Budgeting and Contract Negotiations for Clinical Trials
Strategic and Operational Roadmap: Meeting Mandatory Research Staff Training Requirements
BioBanking Basics: An Overview of Current Legal and Compliance Issues Related to Human Specimens Collected in Research
Development of a Harmonized Clinical Research Program
The Defensive IRB: Lessons to be Learned from the Practice of Defensive Medicine
Tactical Framework for a Clinical Trial Billing Audit
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
Clinical Trials Registries – The Importance of Registering and Following Throughout the Lifecycle of a Trial
Key Considerations and Lessons Learned When Implementing Compliant Research Billing Practice in a Large Academic Medical Center
Negotiating Clinical Trial Agreements with For-Profit Companies
The Role of the Medical Humanist in Human Subject Protection Programs
Documentation and Auditing: The Multilingual Consent Aide Process
Clinical Trial Management: Making the Business Case for CTMS
Clinical Trials: Industry Perspective from the Industry
2010 Annual Meeting - Chicago, IL
Workshop
Fundamentals of Human Research Protection
Electives
Ethical Issues in International Human Research Protections
The Pack Rat Syndrome - Databases, Bio-banks or Documents and Records
Practice Patterns of the Research Coordinator: Challenges Ahead for a Clinical Research Institute
Subject Injury and Research Contracts
Operational Model for a Clinical Research Institute
Taming the Billing Beast: How to Better Manage Clinical Trial Budgets
Reimbursement to Subjects Enrolled in Clinical Research Studies
Human Subject Protection: A Collaborative Approach
Marketing & Business Development for Clinical Research Sites
ROI of Effective Clinical Trial Financial Management: With or Without CTMS
HIPAA Breach Notification Analysis: How to Determine Whether Notification is Required in the Event of a Privacy Breach
2010 NE/MW - Philadelphia, PA
Workshop
Fundamentals of Human Research Protection
Required Sessions
Clinical Trials: Rules and More Rules
Clinical Trials Budget Negotiation
Electives
Subject Recruitment Campaign Utilizing Advertizing
What Research Administrators Need to Know about Complying with Human Research Protections Application
2009 Annual Meeting - Seattle, WA
Workshop
Fundamentals of Human Research Protection
Required Sessions
Clinical Trials: Rules and More Rules
Clinical Trials Budget Negotiation
Electives
Ethical Issues in International Human Research Protections
OLAW Update
OHRP Update
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