Clinical Trials Research Administration Certificate

Clinical Trials Research Administration (CTRA)

The Clinical Trials Research Administration (CTRA) Certificate 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 has been redesigned to cover the critical elements of clinical trials management for research administrators and to more effectively integrate with other SRAI certificate offerings. The redesign maintains the required curriculum which introduces the student to the body of knowledge required to perform as an accomplished clinical trials research administrator. This certificate covers broad topics that allows for its content to be well integrated with the Research Integrity certificate also offered by SRAI.

The CTRA curriculum examines issues relevant to both National Institutes of Health-sponsored and industry-sponsored clinical trials. Much of the material is explored through experiential learning activities from seasoned research administrators including 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 seven sessions for completion of the program.

Certificate Program Requirements

CTRA is comprised of one full-day workshop, five required sessions and two elective sessions. The required courses are listed below; the electives may vary from meeting-to-meeting.

Required Workshop

WS1: A Guide to Clinical Trials Administration

Sunday, June 11 | 9:00 AM - 5:00 PM


Clinical trials are a rapidly changing field in research administration. For this reason, they require careful preparation and oversight. 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 subjects to archiving records, explore the differences between industry and federally funded studies, highlight special concerns and discuss best practices for managing clinical trials.

Content Level: Basic
Learning Objectives:
1. Identify three milestones in the development of clinical research regulations and describe the importance of each.
2. Identify keys to productive and effective post-award management e.g. communication, documentation, and continuing education.

Speaker(s):
Bruce Steinert, PhD, CCRA, Research Manager - Regulatory, Medical College of Wisconsin

Required Sessions

Required Session: CTRA-R
Must Take Five (5)

  • M102: Negotiating Clinical Trial Agreements with For-Profit Companies
    Monday, June 12 | 9:30 – 10:30 AM
  •  T102: The Right Fit - Clinical Research Feasibility
    Tuesday, June 13 | 9:30 – 10:30 AM
  •  T205: Contract of Babel: Reconciling Accounting Billing and Invoicing Terms
    Tuesday, June 13 | 11:00 AM – 12:00 PM
  • T402: Core Matters: Biorepository and Data Protections in Clinical Research 
    Tuesday, June 13 | 3:00 – 4:00 PM
  •  W103: Clinical Trials: Rules and More Rules
    Wednesday, June 14 | 9:30 – 10:30 AM

Elective Sessions

Elective Sessions: CTRA-E 
Must Take Two (2)

  • M202: Sharing Practical Tips Learned Managing Investigator-Initiated Trials at an Academic Medical Institution
    Monday, June 12 | 11:00 AM – 12:00 PM
  • M303: Decentralizing Regulatory & Compliance in a Cancer Research Program (Challenges and Successes)
    Monday, June 12 | 1:30 – 2:30 PM
  • M403: Keeping Up with ClinicalTrials.gov: A Systematic Approach in Maintaining Compliance
    Monday, June 12 | 3:00 – 4:00 PM
  • W204: Human Subjects Protection: Before, During, and After
    Wednesday, June 14 | 11:00 AM – 12:00 PM