Course Content
Clinical Research Data Management Course

Every research study follows a sequence of activities commonly referred to as the research lifecycle.

Understanding this lifecycle is essential because data management activities occur throughout each phase.

Phase 1: Study Conceptualization

Researchers identify a problem and formulate research questions.

Data management activities include:

  • Reviewing feasibility.
  • Identifying data requirements.
  • Contributing to protocol development.
  • Planning database needs.
Phase 2: Protocol Development

The study protocol defines objectives, procedures, variables, and analysis plans.

Data management activities include:

  • Reviewing variables.
  • Defining data collection schedules.
  • Identifying data sources.
  • Planning data flow processes.
Phase 3: CRF Development

Case Report Forms (CRFs) are developed to capture study data.

Data management activities include:

  • Designing forms.
  • Defining field types.
  • Establishing coding standards.
  • Creating completion guidelines.
Phase 4: Database Development

Electronic databases are configured.

Data management activities include:

  • Building REDCap projects.
  • Creating validation rules.
  • Defining user roles.
  • Testing system functionality.
Phase 5: Data Collection

Study personnel collect participant data.

Data management activities include:

  • Monitoring data entry.
  • Conducting quality checks.
  • Managing queries.
  • Supporting study teams.
Phase 6: Data Cleaning

Collected data are reviewed and corrected.

Activities include:

  • Missing value checks.
  • Range checks.
  • Consistency checks.
  • Duplicate detection.
Phase 7: Analysis

Clean datasets are analyzed to answer research questions.

Activities include:

  • Dataset preparation.
  • Variable derivation.
  • Statistical summaries.
Phase 8: Reporting

Results are communicated through reports and publications.

Activities include:

  • Table generation.
  • Figure production.
  • Dashboard creation.
  • Automated reporting.
Phase 9: Archival and Sharing

Data are preserved for future use.

Activities include:

  • Metadata preparation.
  • Dataset documentation.
  • Repository submission.
  • Controlled data sharing.

The data manager contributes to every stage of this lifecycle.