DOMAIN 8: Communications and Teamwork
Encompasses all elements of communication within the site and between the site and sponsor, CRO, and regulators. Understanding of teamwork skills necessary for conducting a clinical trial
8.1
Discuss the relationship and appropriate communication between Sponsor, CRO and clinical research site.
Fundamental Level:
A1. Understand and describe the relationships and appropriate communication channels between regulators, sponsors, CROs and research sites
Example: Demonstrates appropriate written and oral communication between stakeholders in the clinical research operation
Skilled Level:
B1. Apply appropriate professional communication practices in written and verbal interactions with other parties in order to maintain legal and productive relationships during the conduct of a research study
Example: Develops proactive written and oral communication that addresses team related challenges that could impact study execution so that mutually agreed upon solutions can be developed to address the challenges.
Advanced Level:
C1. Establish and maintain productive long-term relationships with all participating parties across the research enterprise to sustain efficient, effective and sustainable clinical trials currently and in the future
Example: Anticipates the needs of all parties participating in the research enterprise and serves as a communication mediator when difficult situations arise that have had previous unsatisfactory results.
8.2
Describe the components of a traditional scientific publication.
Fundamental Level:
A1. Identify the component parts of a scientific publication and the general purpose of each part
A2. Comprehend that a traditional scientific publication describes the outcomes of a research study in a structured and ordered format to contribute to generalizable knowledge and evidence-based practice
Example: Reviews and discusses a published study associated with an ongoing clinical study protocol.
Skilled Level:
B1. Describe the methods for a study that has been published and appreciates the basis for the conclusions made from the results obtained.
B2. Search the literature using key terms to find articles on specific subjects
B3. Explain the difference between a primary source and a secondary source when citing the professional literature
Example: Composes an abstract for a publication or professional presentation accurately citing the literature using primary source data (e.g., able to trace a secondary source back to the originating primary source).
Advanced Level:
C1. Navigate, appraise and assess the content of all component parts within a traditional scientific publication and communicate a both detailed understanding to staff
C2. Describe the relationship of the findings from a clinical study to the relevant human population and current practice context
C3. Write and edit manuscripts as well as apply varying journal citation styles when formatting a manuscript
Example: Given the results of a clinical study, generates and edits a manuscript and/or responds to editorial comments and suggestions in order to develop a final and accepted professional publication.
Fundamental Level:
A1. Explain the structure and contents of a scientific publication.
A2. Identify and utilize reliable sources of information which communicate clinical research findings to the scientific and non-scientific communities
Example: Explains the scientific underpinnings of a clinical trial in terms that can be understood by the non-scientific community.
Skilled Level:
B1. Relate the content and value of clinical research studies to colleagues and the non-scientific community through professional presentations and other verbal and written means
Example: Writes lay summaries of research studies for a journal club or to potential patient populations.
Advanced Level:
C1. Design reports for scientific and non-scientific communities which interpret and explain clinical trial data and appraise the significance of clinical study reports
C2. Facilitate the awareness and further understanding of clinical research protocols and their results to colleagues, advocacy groups and the non-scientific community
Example: Communicates outcomes of a clinical research study to sponsors, colleagues and the non-scientific community.
8.3
Effectively communicate the content and relevance of clinical research findings to colleagues, advocacy groups and the non-scientist community.
Fundamental Level:
A1. Describe and understand the importance of an interdisciplinary team and the values each member can bring to clinical studies
A2. Identify and recognize each member of the team and their respective roles and responsibilities and understand that communications within a clinical study team is vital to the success of the study
Example: Understands the professional roles and clinical practice domains of all members of the clinical study team.
Skilled Level:
B1. Identify and facilitate the activities of the key contacts essential to ensuring effective team operations during a clinical study
B2. Demonstrate an understanding of the cross-functional team in developing a communication plan
Example: Demonstrates the ability to perform the day-to-day operational activities critical to running an effective team (e.g. setting up meetings, developing a communications plan, identification of key contacts both within the team and outside of the team).
Advanced Level:
C1. Mentor others how to work best on a multi-functional clinical study team
C2. Establish the core infrastructure of the clinical study team and ensure effective and efficient communication and teamwork
C3. Incorporate multidisciplinary skills into research teams
Example: Creates study teams and establishes an operational workflow to implement study team communication, cross-training, ensures training documentation is maintained, and provides guidance when needed in order for them to optimize their effectiveness.