Clinical Trials Research Administration 101

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.

The CTRA 101 Certificate is being offered at the 2019 Midwest/Northeast Section Meeting.

CTRA 101 Advanced Placement Test

$30 administrative fee. Only Members may view.

Register Online

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 for your test link.

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 workshop.

A Guide to Clinical Trials Administration

Content Level: Basic

Clinical trials are a rapidly changing field in research administration. Many of the skills needed to administer more traditional investigator initiated, grant funded research projects can be adapted to managing clinical trials. This teaching workshop will examine the basics of clinical trial administration from recruiting projects to archiving records, explore the differences between industry and federally funded studies, highlight special concerns and discuss best practices for managing clinical trials.

Learning Objectives:

  1. Identify three milestones in the development of clinical research regulations and describe the importance of each.
  2. Identify three important regulatory differences between clinical research conducted in the US and in non-US/International regions.

Prerequisites: None

Required Sessions

Must take two.

Clinical Trials: The Industry Perspective

Content Level: All Levels

This is a presentation of the process of drug development from the pharmaceutical industry’s perspective Timelines, quality and cost will be driving factors for discussion. The pharmaceutical industry’s general organizational structure will be introduced. The clinical trial protocol development process and clinical study conduct will be presented. Pharmaceutical drivers for study site selection will be highlighted. Site-based contracts, including budgets, publication rights and intellectual property will also be discussed.

Learning Objectives:

  1. Understand the drug development process including pharmaceutical industry drivers.
  2. Understand how sites are selected and contracts are negotiated for clinical trials.

Prerequisites: None

Negotiating Clinical Trial Agreements with For-Profit Companies

Content Level: All Levels

Tips, traps and tricks of negotiating clinical trial agreements with the industry including a discussion of conducting negotiations via email versus teleconference discussions. Presenters will role play to illustrate tactics and strategies.

Learning Objectives:

  1. Analyze negotiation strategies, identify their individual strengths and weakness and list common mistakes made by negotiators on each side of the table.
  2. Describe the benefits of compromise and tools to help finding it.

Prerequisites: None

Elective Sessions

Must take two.

Electives vary from meeting to meeting.