Data governance and compliance are paramount in clinical research to ensure the integrity, quality, and ethical conduct of studies. Proper data governance practices establish a framework for managing data throughout the research lifecycle, while compliance ensures adherence to regulations, guidelines, and ethical standards. Here's an overview of data governance and compliance in clinical research

1. Welcome
Data Governance and Compliance In
Clinical Research
Mounika Metta
B.Pharmacy
130/072023
10/18/2022
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2. Index
 Data Governance
 Goals
 How it Works???
 Pillars Of Data Governance
 Steps
 Compliance
 Steps in attaining Compliance
 Elements
 Conclusion
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3. Data Governance
Definition. Data governance is the overall management of the
availability, usability, integrity and security of data used in an
enterprise. Effective data governance maps an overall strategy
and builds a framework that directs data management,
distribution, protection, and alignment with industry specific
regulations.
Data governance defines and directs:
•Strategies for data collection
•Data standards
•Methods to support data integration
•Management of enterprise information.
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4. GOALS
1) promote more efficient and timely data access across stakeholders.
2) enhance usability of information to achieve deeper insight into research
processes.
The ultimate goal is to achieve competitive advantage by harnessing data to
drive time and cost efficiencies and increase the likelihood of successful trials.
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5. HOW IT WORK???
Processes. To plan and implement a well-managed clinical trial ecosystem,
data governance uses a centralized, top-down process to create a data
environment in which all research stakeholders operate under a single
framework that spans the entire drug development process. A data governance
oversight board plans and implements technologies and methodologies that:
•Standardize data management processes
•Create a centralized hub to promote collaboration
•Adopt open standards to maintain flexibility and scalability
•Provide tools for fast access to data assets and visibility into research
processes
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6. Pillars of data governance
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Data governance
Data
Quality
Data
Acquisition
Data
Integrations
Data
Consumption

7. • Data Quality: Connecting through Standards
Consistent data standards are necessary to underpin data quality,
management, and applications across increasingly complex research
processes.
• Data Acquisition: Managing More
As big data reshapes drug development processes, sponsors must be
able to manage more data, from more disparate sources, across more
electronic information systems.
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8. • Data Integrations: Connecting Silos of eClinical Data
When all data assets are stored in one place, users have access to a
“single source of truth”—a comprehensive warehouse of information
that can be viewed, shared and analyzed to track study operations and
respond to problems quickly
• Data Consumption: Analytics, Dashboards, Reports
Data consumption is concerned with optimizing the ways data are
used.
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9. Steps in data governance
 Oversight Organization
 Implementation Roadmap
 User requirements
 Data and technologies
 Solution architecture
 Business care
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10. Compliance
Research Compliance can mean many different things to
different groups of individuals and organization involved in
research activities. Typically, human research compliance
addresses adherence to rules, regulations, policies, and
standards of conduct that govern research.
Types of Compliance
There are two main types of compliance that denote where
the framework is coming from: corporate and regulatory.
Both corporate and regulatory compliance consist of a
framework of rules, regulations and practices to follow.
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11. Steps in attaining Compliance
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12. Elements in compliance
1. Implementing written policies and procedures
1. Standards of Conduct Guide
2. Ethics policy
2. Designating a compliance officer and compliance committee
1. Compliance Advisory Committee
3. Conducting effective training and education
1. Compliance Training
4. Developing effective lines of communication
1. Hotline
5. Conducting internal monitoring and auditing
1. Internal Audits
2. Compliance Inspections
3. Peer Reviews
4. External Audits, Reviews and Inspections
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13. 6. Enforcing standards through well-publicized disciplinary guidelines
1. Consequences levied consistently regardless of the employee’s stature
within the organization. Enforcement consistent with appropriate
disciplinary action.
2. HR’s managing conduct webpage
7. Responding promptly to detected problems and undertaking corrective action
1. Hotline procedures require two weeks for action; elevation to VP/President
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14. Conclusion
Data governance and data compliance plays an important
role in the smooth conduction of clinical trials, one plays
an important role in safeguarding which include the
Managing, Improving, Monitoring, Maintaining,
Protecting and the other for the proper conduction of
trials.
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15. Thank You!
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(India | Canada)
9121151622/623/624
info@clinosol.com
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