Thoughtful Data Management through SOPs · 2020-05-18 · COM Clinical Trials Management...
Transcript of Thoughtful Data Management through SOPs · 2020-05-18 · COM Clinical Trials Management...
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Advancing Today’s Discoveries to Improve Health
Thoughtful Data Management through SOPs
Angela Sow, MACRP, CCRPClinical Research Manager, Center for Clinical and Translational Science
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Advancing Today’s Discoveries to Improve Health
Outline
COVID-19 implications for research data management
Federal and local research guidance
Resources
Essential SOPs
Application of COVID-19 related data management practices in a pragmatic multi-center RCT
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Advancing Today’s Discoveries to Improve Health
COVID-19 Implications for Research Data Management
Global disruption to basic, clinical and translation research projects
Challenges in data sharing, management, and pursuant to existing IRB-approved protocols, data use agreements, and data management plans
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Advancing Today’s Discoveries to Improve Health
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Advancing Today’s Discoveries to Improve Health
Federal COVID-19 Related Guidance for Clinical Research
OMB M-20-17 Memorandum to the Heads of Executive Departments and Agencies, March 9th
NIH issued Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19, March 16th
FDA released FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, March 19th
NSF issued NSF Implementation of OMB Memorandum M-20-17, March 19th
OHRP issued OHRP Guidance on COVID-19, April 8th
https://research.osu.edu/news-events/coronavirus-and-your-research-program/
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Advancing Today’s Discoveries to Improve Health
Local COVID-19 Guidance for Clinical Research
OSU ORRP released Interim Ohio State Guidance and FAQs on Human Subjects-Related Research Visits During the COVID-19 Outbreak, March 12th
OSU Office of Research, Message from Morley O. Stone, Senior Vice President, March 15th
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Advancing Today’s Discoveries to Improve Health
Local Resources for Clinical Research Data Management
COM Clinical Trials Management Organization (CTMO) SOPs SOP-01: Writing, Training and Maintenance of SOPs
SOP template
RPA template
SOP training and compliance form
SOP revision history log
SOP-16: Data Management
Located on OneSource and CCTS website
OSU Research Commons Best Practices for Research Data Management
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Advancing Today’s Discoveries to Improve Health
Local Resources for Clinical Research Data Management
OnCore Secure web-based clinical trial management system that captures all
aspects of the clinical trial lifecycle
COM Clinical Trials Office (oncology) and College of Medicine Office of Research (non-oncology)
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Advancing Today’s Discoveries to Improve Health
Safeguarding Data and Information amid COVID-19 Pandemic
Everyone’s responsibility while working on-site as well as remotely
Development and implementation of SOPs is critical to ensuring quality data and reducing risks
SOPs in response to the COVID-19 pandemic are needed for the various risk mitigation efforts in order to ensure reliability of the data that will subsequently be used to make scientific conclusions
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Advancing Today’s Discoveries to Improve Health
COVID-19 Data Management SOPs
Telehealth and remote assessments
Electronic consenting and enrollment
Documentation of out of window follow-up visits and cessation of on non-essential study procedures or interventions
Adverse event reporting and updating of adjudication definitions
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Advancing Today’s Discoveries to Improve Health
COVID-19 Data Management SOPs
Revised statistical analysis plans
Revised recruitment plans
Updated data management plans and data use agreements
Reporting of protocol deviations
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Advancing Today’s Discoveries to Improve Health
Application of COVID-19 related data management practices in pragmatic multi-site RCT
The LOFT-HF study (PI: William T. Abraham, MD)
Pragmatic multi-site RCT evaluating use of oxygen therapy for treat of Central Sleep Apnea (CSA) in patients with heart failure (n=858) across 25 sites
OSU serves as Clinical Coordinating Center and participating site
Central IRB oversight (Vanderbilt University Medical Center)
Comprehensive Manual of Procedures (MOP)
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Advancing Today’s Discoveries to Improve Health
Application of COVID-19 related data management practices in pragmatic multi-site RCT
Memorandum of cessation of in-person enrollment and follow-up visits
Site surveys of COVID-19 impact on research operations
Frequent site communications Bi-weekly investigator and coordinator calls
Weekly Individual CCC-site calls
Monthly newsletter
Dynamic study portal
Protocol amendment expanding inclusion criteria
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Advancing Today’s Discoveries to Improve Health
Application of COVID-19 related data management practices in pragmatic multi-site RCT Revisions to the Manual of Procedures (MOP)
E-consenting
Discontinuation of non-essential study procedures
Virtual follow-up visits
AE and protocol deviation reporting and revision to adjudication definitions
Recruitment plan
Statistical analysis plan
Data monitoring and management plan
Study equipment distribution
Protocol amendment pending
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Advancing Today’s Discoveries to Improve Health
Development of Research SOPs Inquiries
Center for Clinical and Translational Science (CCTS)
Angela Sow, MACRP, CCRP
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Advancing Today’s Discoveries to Improve Health
THANK YOU