Clinical Trials Research Administration

About 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 will vary meeting-to-meeting.

Required Workshop

A Guide to Clinical Trials Administration

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 five (5).

Clinical Trials: The Industry Perspective

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

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

 

Determining Study Feasibility at Your Site

This is applicable for all studies (i.e., investigator initiated, industry funded, foundation funded or federally funded).  The goal is to ensuring sufficient interest in the study design and research questions.  Not just doing a study to do a study.  The next steps are ensure that there are proper resources (i.e., study staffing including coordinators, investigators, research assistants; IRB and contract review teams, statisticians, etc.) to conduct the study; proper facilities (access to investigational pharmacy; inpatient or ambulatory facilities, etc.) and equipment (centrifuge, freezers, access to MRI or CT equipment); and sufficient and proper patient populations.   Determining the proper mechanism for scientific review to ensure validity of the research questions.  Proper financial review of direct and indirect costs and access to legal review through the grants and contracts team.

Learning Objectives:

 

  1. Is the study answering relevant research questions through rigorous methodologies?
  2. The ability to analyze the legal, fiscal, ethical and scientific review of clinical trials to ensure that you are choosing the right studies for your site.
  3. Is this study helpful to your patient populations (i.e. are you meeting the clinical goals important to your medical environment). 

Prerequisites: None

 

Biorepository and Data Management Considerations for Clinical Trials

Changes of the common rule generated much attention around the management of biorepositories and related data in clinical research. This session will address the following topics for research administrators that are involved in clinical trial activity related to biorepository and data management: 1) Discussion of various repository models; 2) Ideas for repository management considerations; 3) Review of multiple regulatory considerations (HHS, FDA, and HIPAA); 4) Impact on informed consent and privacy and confidentiality of data; and 5) Bio-specimen research scenarios for both current and future regulatory considerations.

Learning Objectives:

  1. Identify different approaches and models for biorepository and data management for clinical research trials.
  2. Understand the impact of different regulations on bio-specimen and related data management clinical research.

Prerequisites:  None

 

Clinical Trials: Rules and More Rules

Clinical trials must comply with the Good Clinical Practice guidelines (GCP). Unfortunately, the GCP is not well defined. This session will review the 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:  None

 

Clinical Trials Budget Negotiation

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: None

 

Research Integrity: The Institutional Perspective

This session can be used to fulfill the “Research Integrity General” category for the Research Integrity certificate. Academic and other research institutions are becoming more and more aware that many faculty, researchers, staff and students are not properly trained in ethics, professional standards and responsible conduct of research. This session provides a brief summary of the overall issues encountered and approaches to enhance the training and competency in research integrity and professional standards across several different types of organizations.

Learning Objectives:

  1. Identify the institutional and cultural-discipline-specific challenges to RCR training.
  2. List strategies to address the challenges in gaining "buy in" and implementing RCR training.

Prerequisites: See Research Integrity Certificate

Elective Sessions

Must take two.

Electives vary from meeting to meeting.