Course Content
Data Entry, Validation, and Access Control
This chapter explores the operational aspects of data collection within REDCap, including data entry workflows, validation procedures, user rights management, audit trails, and quality assurance activities that help ensure research data remain reliable and compliant with regulatory standards.
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Data Quality Management and Query Resolution
This topic is about ensuring that data is accurate, complete, and consistent. It covers identifying, investigating, and correcting errors or discrepancies in data. It also focuses on timely resolution of data queries to maintain data integrity and reliability.
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Introduction to R for Clinical Data Management.
This topic introduces R, an open-source programming language used for statistical analysis, data management, and visualization. In clinical research, R is applied to clean, analyze, and report data in a reproducible and reliable manner.
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Clinical Research Data Management Course

REDCap includes Data Quality tools that help identify potential problems in project data. These tools can run predefined rules and custom rules to detect missing values, invalid values, field validation errors, duplicate records, and logic problems. While the exact features available may depend on institutional configuration, the Data Quality module is an important starting point for routine review.
Predefined REDCap rules may identify blank values, invalid values, outliers, or duplicate records. Custom rules allow the data manager to define study-specific logic. For example, a custom rule might identify records where discharge date is before admission date, day 28 follow-up date is outside the allowed visit window, malaria test result is missing for enrolled participants, or pregnancy status is recorded for participants for whom the field should not apply.
Data Quality rules should be aligned with the data quality plan. It is not enough to run rules occasionally without a response process. The study team should decide how often rules are run, who reviews the output, which findings become queries, and how resolved issues are documented. For example, a weekly quality review may generate a list of missing day 28 outcomes that site coordinators must resolve within seven days.
REDCap reports complement Data Quality rules. Reports can show missing forms, incomplete records, open queries, enrollment by site, visit completion, unresolved adverse events, or delayed data entry. Reports are often more understandable to site users than raw rule output.
A well-designed set of reports can support both central monitoring and site self-management.For larger studies, REDCap checks may be supplemented by R scripts. R can perform more complex checks, summarize trends, visualize missingness, detect unusual site patterns, and generate automated quality reports. The course will introduce R-based quality checking in later chapters, but learners should understand that REDCapandRcanworktogether. REDCap provides structured capture and immediate validationÍž R supports reproducible, flexible, and
scalable review.