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Course Objectives:
High quality clinical research requires careful protocol
compliance from all staff members caring for the research study
participants. Patient care procedures for clinical research
protocols are frequently administered by clinical staff that are not
directly working with the Investigator or and not working directly
with the research study. Data acquisition, from the research
participants, and data integrity (completeness, timeliness and
accuracy) can be severely impacted by non-research personnel who do
not have adequate education in standard research methods. This can
result in compromised data quality, which can scientifically and
ethically jeopardize the integrity of clinical research studies.
Clinical staff members are often overlooked by educators who
target clinical research team members when teaching proper data
collection methods for clinical research studies. Clinical staff
members are a vital part of the clinical research process, but their
impact on the integrity of research data is rarely addressed
formally.
To promote the responsible conduct of human subject research,
this project entails developing a novel on-line educational program
designed to instruct clinical staff in proper methods of collecting
and recording clinical research information from human research
subjects. This education program focuses on improving data integrity
by outlining the purpose of clinical research studies, explaining
the importance of strict adherence to the research protocol and the
impact on the quality of the research data, staff members’ roles in
correct and complete data documentation methods.
Learning Objectives for Module
1:
- To understand the formal definition of research, specifically,
clinical research.
- To differentiate between the types of clinical research
studies and the different types of medical, demographic, and
scientific data that may be obtained by such studies.
- To understand how a clinical research study is developed,
approved, and conducted.
- To verbalize the roles in a clinical research team and how
clinical staff interface with the research team.
Learning Objectives for Module
2
- To differentiate between routine clinical/medical data
collection and research data collection.
- To define “data integrity” and state its importance.
- To determine tests and procedures outlined in a clinical
research protocol.
- To search the protocol and determine specific study data to be
obtained and recorded.
- To be able to access the research protocol, know how to read
the protocol, and how to find key information.
- To differentiate between incident reporting, adverse event
reporting, serious adverse events, toxicities, and unusual
events/behaviors.
- To define the clinical record, the research record, source
documentation and to differentiate among them.
- To verbalize how clinically obtained medical data becomes a
part of the research record and how that data is utilized for
scientific analysis and scientific reporting.
- To understand the role of clinical staff in recording data
that will be utilized in a research study and become part of the
research record. To verbalize the clinical staff role in the
research process.
Learning Objectives for Module
3
- To describe the pertinent Federal regulations, International
Conference on Harmonization Good Clinical Practices (pertaining to
research), and other established standards for clinical research
data collection, storage, management, and analysis.
- To describe the definitions of “adverse events” and “serious
adverse events”.
- To outline the reporting requirements for data collection and
reporting for adverse events and serious adverse events.
- To verbalize how research data is monitored and audited for
accuracy, completeness and integrity.
- To explain the impact of the clinical staff member on research
data, and how incorrect or incomplete data comprises data
integrity and compromises the quality of the scientific
investigation.
Learning Objectives for Module
4
- To identify when a patient is also a research protocol
participant.
- To learn where to find the research protocol or information
pertaining to the research.
- To use medical record forms to record research data thoroughly
and accurately.
- To record and report adverse events.
- To identify the persons or agencies that will be reviewing
research data, and your impact on that review.
- See
all modules
This project has been funded through the support from the
U.S. Department of Health and Human Services
Office of Research Integrity
1101 Wootton Parkway, Suite
750
Rockville, Maryland, 20852
St. Jude Principal Investigator
Cheryl M. Chanaud, PhD
Vice President, Clinical
Research Administration
Team Members
- Amy Doville, Director, Clinical Research Education
- Loraine Avery, Central Protocol Officer
- Dana Hawkins, Hematology/Oncology
- Michael Hans, Nursing Education
- Geraldine Robinson, Nursing Education
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