The Clinical Research Lifecycle
Table 1
Table
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Table 1
Table
Table 1
| Lifecycle phase | Data management responsibilities |
|---|---|
| Concept development | Assess feasibility of data sources, advise on measurable outcomes, identify early data risks |
| Protocol development | Translate objectives, endpoints, visits, and procedures into data requirements |
| CRF design | Create clear forms, define variables, specify coding, prepare completion guidance |
| Database setup | Configure REDCap project, validation rules, user rights, reports, and audit settings |
| Study training | Train users on data entry, confidentiality, source documentation, and query response |
| Data collection | Monitor completeness, timeliness, consistency, and site performance |
| Data cleaning | Resolve discrepancies, check ranges and logic, prepare analysis datasets |
| Analysis and reporting | Support dataset exports, documentation, tables, dashboards, and reproducible reports |
| Archival and sharing | Preserve data, metadata, audit records, approvals, and controlled access arrangements |