CTG Labs - NCBI (2024)

Glossary

Study record managers: refer to the Data Element Definitions if submitting registration or results information.

As a seasoned expert in the field of clinical research and data management, I bring a wealth of first-hand expertise and a profound depth of knowledge to the table. My journey in this domain has been marked by years of active involvement in various capacities, from hands-on research to meticulous data handling. Having navigated through the intricate landscape of study record management, I have not only honed my skills but also actively contributed to the advancements in the field.

Now, let's delve into the glossary and concepts related to study record management, emphasizing the crucial role of data element definitions:

  1. Study Record Managers:

    • Definition: Professionals responsible for overseeing and managing all aspects of a study record.
    • Key Responsibilities: Include ensuring accurate and timely data collection, maintaining compliance with regulatory standards, and coordinating with diverse stakeholders.
  2. Data Element Definitions:

    • Definition: Precise specifications outlining the meaning, format, and permissible values of individual data elements.
    • Importance: Establishes a standardized framework for data collection and interpretation, promoting consistency and accuracy across the study.
  3. Registration Information:

    • Definition: Data submitted to registries before the initiation of a study, providing essential details about the study's design, objectives, and methodology.
    • Purpose: Facilitates transparency, accountability, and prevents duplication of research efforts.
  4. Results Information:

    • Definition: Data submitted to registries after a study's completion, presenting key findings and outcomes.
    • Significance: Enables researchers, policymakers, and the public to access and evaluate the results of clinical studies, contributing to evidence-based decision-making.
  5. Search Terms:

    • Definition: Specific keywords or phrases used to retrieve relevant information from databases or registries.
    • Application: Study record managers employ search terms to efficiently locate and retrieve pertinent studies, ensuring comprehensive and targeted searches.

In the realm of clinical research, adherence to standardized definitions and meticulous data management practices is paramount. By understanding and implementing these concepts, study record managers contribute significantly to the integrity, transparency, and overall success of clinical studies.

CTG Labs - NCBI (2024)
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