Clinical Research and Data Management

Defining the Best Practices Framework for Managing Data Assets

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Clinical Research and Data Management may be daunting since different definitions and approaches exist. How do you develop best practices for establishing your clinical trial data management framework? Element Technologies is a firm that aims to provide reliable solutions for issues concerning business data governance, quality, and collaboration. It’s critical to develop best practices for constructing your data governance framework, especially when the work environment changes.


Clinical trial data management is becoming increasingly important as businesses shift from on-premises to hybrid or remote working models. According to recent research, strong data governance rules and practices may help businesses overcome significant data protection and privacy problems as workers interact and share data across remote settings.                


Is it better to manage or govern data?


Is there a distinction to be made here? Yes, but the two ideas are intertwined. Data governance is managing data availability, relevance, usability, integrity, and security at the enterprise level. In addition, data governance aids businesses in the management of institutional knowledge by establishing data owners, business terminology, rules, policies, and processes across the full data chain.


Data management is a technological application of data governance, a strategy for defining and managing organizational data. Data management rules and procedures guarantee that data is correctly gathered and managed, including masking, encryption, profiling, and defining tools and techniques.


As you develop a robust basis for data governance knowledge, We recommend considering the following points.


Pay special attention to the business strategy.


An active model, also known as an asset model, describes how a company defines roles, responsibilities, business terminology, data domains, and other aspects of its operations. As a result, workflows and procedures are impacted. As a result, it influences how a company manages data.


Any data governance program’s operational model is the foundation. The goal is to create a governing framework for the business. The structure may differ depending on the organization:


  • Organize (a central authority manages everything) 
  • Federation or decentralization (there are multiple groups of authority)


Within the data domains, locate essential data pieces.


The next step in data governance is identifying the key data substances after classifying the data domains. There’s no need to focus on all of the data artifacts in the early steps of your data governance program. Instead, only identify what is genuinely vital to the business as a data governance best practice.


Establish control measurements.


Setting control metrics to maintain the data governance program is the next data governance best practice. Data governance is a long-term commitment to encouraging data-driven decision-making and commercial potential. It prepares a company to satisfy business requirements. The following important actions are included:


  • Establishing automated workflow protocols and thresholds for approval, escalation, review, voting, and issue management.
  • Using workflow processes to implement governance, data domains, and important data items
  • Developing program progress reports
  • Using automated workflow procedures to capture feedback

Track your progress using metrics.


The effectiveness of your data governance program must be measured and shown, just like any other reform. You’ll need statistics to back up each step you take once you’ve gotten executive sponsorship from your business case. Before you start implementing data policies, define your metrics. This allows you to establish a baseline based on your existing data management procedures.


Regularly monitor your progress by referring to the initial measurements. This acts as a checkpoint to ensure that your data governance best practices are successful, not just in theory. A strategy that appears to be perfect on paper may not work out as well in practice. Therefore, it’s critical to maintain a close watch on your governance approach and be adaptable when making changes.


Encourage open dialogue.

Whether you’ve been getting warmed up with data governance or have been doing it for a while, it’s critical to communicate early and regularly. From recognizing triumphs to reconfiguring after a setback, consistent and effective communication helps reveal the influence of the approach.


The data governance program’s communications leader should be a member of the executive team, such as the Chief Information Officer (CIO) or the Chief Data Officer (CDO). These individuals serve as the primary point of contact for information on the organization’s governance processes. Team leaders and data owners can provide regular updates to the executive. The executive team member then informs the remainder of the leadership team of the most important information.


Assign positions and tasks.

Assigning targets and accountability levels across the organization provides a solid platform for what is frequently a considerable cultural and procedural shift. The following are the usual roles that should be established early in the process.


  • Directors or Supervisors who understand the data governance goal and ensure that the program is adequately funded.
  • The data governance council is the group in charge of directing the program’s strategy, prioritizing projects and activities, and establishing data definitions, policies, and standards.
  • The data governance board is the team in charge of defining practical procedures and rules for using data as a corporate asset.
  • Individuals in charge of data for certain roles inside the company are known as data owners.
  • Individuals who implement data governance systems to ensure data quality and add order and value to unstructured data are data stewards.
  • Individuals who enter and use data in their work obligations are known as data consumers.

Create a Data Governance Plan


Developing a data governance framework is a huge task that involves practically everyone in the company. However, with careful planning and execution, you’ll be well on your way to data governance maturity and widespread acceptance in no time.


Visit to get the best framework and solutions for your clinical research and data management.

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