Training needs of clinical research associates - Resource - NCBI - Read the article to know skills required for becoming a CRA "D"

Abstract

Clinical research is a relatively new field in our country that has seen very rapid growth in the last few years. Availability of personnel appropriately trained to the specific requirements of the role they will perform in clinical research is critical for capacity expansion. Our study attempts to understand the specific areas of knowledge and skills that are important for the role of a clinical research associate. The survey was conducted among clinical research professionals from industry and academia who had more than five years of clinical research experience and held important decision making positions in clinical research (stakeholders). The survey questionnaire was designed as a matrix of various clinical research roles on the y-axis and six knowledge modules and eight skills on the x-axis. Respondents were asked to rate the importance of the knowledge /skills to the role of clinical research associates on a three point scale. In discussing results, a significant response was considered to be 50% or greater positive response from the total group. The significant findings were that general, ethics and clinical trial execution modules were rated as critical for the role of clinical research associate. Regulatory module was rated as important for the role. The other significant responses were that three of the sub-topics in the methodology module - framing a research proposal/protocol and experimental design, designing case report forms and EDCs and conducting PK studies - were rated as important and one sub topic in the data management and statistics module was rated as not important. All the skills except leadership skills were rated as critical for the role. The findings of our survey were in general on the lines of expectations of performance of the role. The general, ethics and clinical trial execution modules are critical knowledge areas for the role of a clinical research associate. No clear trends emerged for some of the other modules. Leadership skills were not rated as critical to the role. This kind of a survey gives a good direction when training curriculum has to be designed for specific roles in clinical research. However, there is a need to expand the sample size to fine-tune the knowledge and skills areas.

Keywords: Clinical research associates, clinical research training, modules, performance, roles, topics

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INTRODUCTION

GATT compliance in 2005 and the positive regulatory changes that ensued have made India an increasingly attractive location for clinical research. We have witnessed a rapid growth in this sector in the last few years[1] with projections for increased requirements for personnel in the various roles like clinical research associate (CRA), investigators, site coordinators, data management personnel, statisticians etc.[2] These roles are very well differentiated in terms of their performance expectations and availability of training tailored to the specific role requirements will be critical to capacity expansion.[3]

The CRA has the very critical role of ‘monitoring’ a clinical trial, which includes that the rights and well-being of human subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s). About the training of monitors, the GCP guideline mentions only that monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately and that a monitor’s qualifications should be documented.

Since clinical research itself is a relatively new field in India, we considered it is important to understand the requirements of knowledge and skills for the diverse roles. This paper describes the survey findings of the knowledge and skills needed for the role of a clinical research associate. We conducted a survey among key stakeholders in clinical research professionals in the industry, who by virtue of their positions had directly or indirectly employed or worked with CRAs.

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MATERIALS AND METHODS

We chose to have the opinion of important stakeholders in clinical research on what they think are important knowledge and skill areas for a person performing the role of a clinical research associate. We looked for people who had more than five years of clinical research experience and held important decision making positions in clinical research (stakeholders). Forty eight such people were identified and they formed the population for this survey. The survey questionnaire was designed as a matrix of various clinical research roles on the y-axis and the areas of knowledge and skills on the x-axis.

Knowledge areas were further classified into six broad categories with sub-topics in each module as follows-

• General
• Ethics
• Regulations
• Methodology
• Data management and statistics
• Clinical trial execution

Skills were classified as-

• Leadership
• Teamwork
• Negotiation
• Conflict management
• Interpersonal skills
• Computing
• Presentation skills
• Communication skills

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