U-M Study Coordinator Competency Statements
I.
II.
III.
Protocol Development and Study Management
1. Implements research study protocols
The following behaviors are some examples that could be considered evidence of competence.
There are probably many other behaviors that could be included.
 Define basic research terminology
 Diagram the study development process
 Identify the main sections of a research protocol and summarize key elements related to
protocol execution
 Use protocol to develop an operational plan for conducting the study and to complete
regulatory and sponsor required documents
2. Communicates with members of the study team
The following behaviors are some examples that could be considered evidence of competence.
There are probably many other behaviors that could be included.
 Define roles and responsibilities of study investigators, research staff, research
participants, and other study team members as specified in the research protocol
 Define, apply, and monitor best practices for research in regulations, data quality,
human subjects protections and documentation
3. Develops a recruitment plan as part of a research protocol
4. Manages participation and withdrawal from studies
Recruitment
1. Communicates study purpose to potential participants both orally and through the
development of written materials
The following behaviors are some examples that could be considered evidence of competence.
There are probably many other behaviors that could be included.
 Identify and apply key concepts in ethical human subject research recruitment
 Use standardized patient interactions to evaluate communication
 Evaluate development of written materials
2. Develops plan to retain participants throughout the duration of the study
3. Identifies study population and recognizes study participants who might participate in other
studies
Informed Consent
1. Locates and downloads current IRB-approved informed consent documents from
eResearch
2. Identifies study team members eligible to conduct informed consent process
3. Obtains valid informed consent
The following behaviors are some examples that could be considered evidence of
competence. There are probably many other behaviors that could be included.
 Employ U-M regulatory and departmental guidelines to conduct informed consent
interviews with research participants
o Identify potential study participants who may be vulnerable or in a special population
o Identify appropriate representatives to consent for participants who are unable to
provide consent for themselves
o Select an appropriate setting to conduct informed consent interview in accordance
with HIPAA guidelines
o Allow adequate time for participants to ask questions and have their questions
answered
o Address essential elements of informed consent with potential study
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participants
Conduct informed consent interview with appropriate techniques to assess
participant understanding
4. Recognizes and corrects common errors on informed consent documents
The following behaviors are some examples that could be considered evidence of
competence. There are probably many other behaviors that could be included.
 Reviews informed consent document for completeness, accuracy, and consistency
with protocol and IRB requirements
5. Documents informed consent process according to U-M regulatory procedures
The following behaviors are some examples that could be considered evidence of
competence. There are probably many other behaviors that could be included.
 Obtain informed consent before conducting research-specific procedures
 Provide copy of informed consent document to research participant
 Utilize appropriate procedure to include informed consent in participant records
Data Management
1. Collects, enters, and maintains study records
The following behaviors are some examples that could be considered evidence of
competence. There are probably many other behaviors that could be included.
 Collects data and maintains records as required by a quality assurance plan
 Applies appropriate procedures for data security and storage
 Applies appropriate data management practices to protect patient confidentiality
and data integrity
2. Disseminates study data and results
Regulations and Compliance
1. Distinguishes among occurrences that may require reporting
2. Identifies and reports exceptional situations during implementation of a research study
The following behaviors are some examples that could be considered evidence of
competence. There are probably many other behaviors that could be included.
 Submit required complete information in the required timeframe to all parties to
whom the study has legal or contractual reporting obligations
3. Applies regulations and guidance as they relate to the conduct of the study
UM System Requirements
1. Uses U-M systems and databases to manage research
The following behaviors are some examples that could be considered evidence of competence.
There are probably many other behaviors that could be included.
 Identify, access and accurately use appropriate electronic U-M systems to maintain
regulatory compliance, reimburse research participants, and manage clinical
research billing
 Utilize electronic systems and databases to meet required reporting and regulatory
guidelines
o
IV.
V.
VI.
These competency statements were developed by University of Michigan study coordinators for
University of Michigan study coordinators. They are intentionally very broad. For some of them,
examples behaviors have been provided that could be considered evidence of competence.
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