Fundamentals of Clinical Research in the CTNlib.adai.washington.edu/ctnlib/PDF/347.pdf2009 Web...
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2009 Web Seminar Series 2009 Web Seminar Series Fundamentals of Clinical Research in the CTN Fundamentals of Clinical Research in the CTN Instructors: Ron Jackson, M.S.W. Christie Thomas, M.P.H.
Transcript of Fundamentals of Clinical Research in the CTNlib.adai.washington.edu/ctnlib/PDF/347.pdf2009 Web...
2009 Web Seminar Series2009 Web Seminar Series
Fundamentals of Clinical Research
in the CTN
Fundamentals of Clinical Research
in the CTN
Instructors: Ron Jackson, M.S.W. Christie Thomas, M.P.H.
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Questions or Comments
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Introduction
This is a two-hour seminar orienting novice research staff to the CTN and the clinical research environment within the CTN. Participants will receive explanation of the essential principles critical to facilitating CTN research in a clinical treatment program.
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IntroductionPolling Questions
“Hmm….well…my favorite color is
Orange.”
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Topic 1: CTN overviewTopic 2: Research team Topic 3: Research protocolTopic 4: Navigating the Network to
ensure success
Training Outline
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Topic 1 CTN Overview
NIDA (CCTN)
Node / RRTC
Node
Community Treatment Programs (CTPs)
CTN
CCCEMMES
DSCDCRI
LOGISTICSSEI
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Topic 2Research Team
Sponsor (NIDA)Executive CommitteeLead NodeNode Principal Investigator (PI) and TeamCTP PI and Team
1 of 2
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Topic 2Research Team
CTP PICTP Co-PIsCTP Study Coordinator/Research AssistantCTP Study Research AssistantTherapists/CounselorsTechniciansPharmacistClinicianOther Staff
2 of 2
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Topic 2 Polling Questions
“Hmm….A…no C, errr…B, yeah B.”
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Topic 3Research Protocol
Research ProtocolProvides a plan for the essential aspects of the proposed research Key to standardized study conductClearly and succinctly describe (the 5 W’s)
Why the study is being doneWhat will be done in the studyWhere the study will be done Who is involved in the research studyWhen study interventions will take place
Requires initial and continuing IRB approval
1 of 5
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Topic 3Research Protocol
Research QuestionPrimary and secondaryQuestion influences proper Study Design
Background and SignificanceProvides rationale for current studyRelevance in obtaining informed consent
2 of 5
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Topic 3Research Protocol
Study Design and ProceduresStudy Population
Inclusion / Exclusion CriteriaTheir significanceReason for strict adherenceImpact on recruitment strategy
RandomizationProduces comparable study groupsRemoves potential allocation biasStatistical significance
Recruitment, Retention and Follow-up
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Topic 3Research Protocol
Data Collection and ManagementMaximizing Quality Data
Protocol design & Operations ManualFormsTrainingPretesting
Electronic Data Capture (EDC)TimelinessQueriesSource
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Topic 3Research Protocol
Reporting and MonitoringSafety
Minimize participant riskMonitor & report adverse events
Quality AssuranceProtocol AdherenceMonitoring and Audits
Regulatory OversightDSMB, IRB, Sponsor, Executive Committee
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Topic 3Research Protocol
Close-outData AnalysisReporting Results
Publications committeeBlending Products
5 of 5
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Topic 3 Polling Questions
“Hmm….A…no C, errr…B, yeah B.”
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Topic 4Navigating the network
to ensure successIt’s all about relationships
CTPResearch vs. non-research staff
NodeProtocol Team
CommunicationImportance of being on callRole of e-mail as documentationFeedback to the system
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Topic 4 Polling Questions
“Hmm….A…no C, errr…B, yeah B.”
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Summary of Training
Well-designed clinical trials adhering to these fundamental principles…
Protect human research participantsProtect research staffProtect the public interestEnsure the continued support for clinical trials by maintaining high standards
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Questions
Fundamentals of Research
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This concludes our presentation today. Thank you for joining.
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Conclusion
