Clinical Trials Research Administration 201

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 Emily Mincey at emincey@srainternational.org to verify you have previously taken CTRA 101 or to request the CTRA 101 advanced placement test (test requires a $30 administrative fee.)

CTRA101 Advanced Placement Test

Register Online by sending an email to Emily Mincey emincey@srainternational.org. $30 administrative fee.

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 emincey@srainternational.org  for your test link.

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 workshop.

Fundamentals of Human Research Protections

Content Level: Basic

This workshop includes a basic introduction to the principles underlying human research protections; the regulatory requirements for reviewing, conducting, and overseeing research with human subjects and the current issues facing the research enterprise. This workshop will look at human research protections in a historical context; the regulations that govern research with human subjects; and the structure and requirements of IRBs. Following an overview, the workshop will explore hot topics such as vulnerable populations, COI, noncompliance, among others.

Learning Objectives:

  1. To learn the basic concepts regarding the use of human research subjects including the requirements of the Institutional Review Boards (IRBS).
  2. To identify current issues regarding research involving human subjects.

Prerequisites: CTRA101 Certificate

Required Sessions

Must take two.

Clinical Trials: Rules and More Rules

Content Level: Intermediate

Clinical trials must comply with the Good Clinical Practice guidelines (GCP). Unfortunately, the GCP is not well defined. This session will review Department of Health and Human Services, Food and Drug Administration, and major international regulations and guidelines, as well as other institutions governing clinical research. Participants will learn how the actions of regulatory agencies affect budget development, contract negotiations and the way studies are conducted. Topics will include the ethical origins of the GCP, historic milestones and their regulatory significance, and discussion of best practices to enhance regulatory compliance.

Learning Objectives:

  1. Identify three important documents that form the core ethical basis for the regulatory environment.
  2. Identify three best practices for improving regulatory compliance in clinical trials.

Prerequisites: CTRA101 Certificate

Clinical Trials Budget Negotiation

Content Level: Intermediate

Budgets for clinical trials should be based on sound accounting principles and an accurate analysis of the protocol. Often, establishing the costs for procedures is relatively straightforward, but accurately estimating hidden costs, such as investigator time and start-up costs, can be more difficult. A systematic process for analyzing protocols, determining costs and negotiating budgets will be discussed, along with relevant aspects of contract negotiations and establishing payment schedules. Tips to optimize budgeting for clinical trials will also be presented.

Learning Objectives:

  1. Learn the four components of a clinical trial budget.
  2. Explain the differences between budgeting for clinical trials funded by industry versus federal sources.

Prerequisites: CTRA101 Certificate

Elective Sessions

Must take two.

Electives vary from meeting to meeting.

Certificates