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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
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
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
Advancing Today’s Discoveries to Improve Health
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/
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
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
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)
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
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
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
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)
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
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
Advancing Today’s Discoveries to Improve Health
Development of Research SOPs Inquiries
Center for Clinical and Translational Science (CCTS)
Angela Sow, MACRP, CCRP
Advancing Today’s Discoveries to Improve Health
THANK YOU
