Source Documentation and Data Integrity
D05The two competencies
C09 Create or evaluate attributable and contemporaneous source records.What this looks like on a Tuesday
You write the note at the visit, sign and date it today, and never fill yesterday in from memory.
C10 Maintain accurate, complete, consistent, and traceable data.What this looks like on a Tuesday
The weight in the chart and the system disagree. You find out which is right and leave a trail.
Where it weighs most
- RP-CRC Clinical Research Coordinator · Inside Site 204
- RP-CRA Clinical Research Associate or Monitor · Inside Terminal C
- RP-CDM Clinical Data Management Professional · Inside Data Works
- RP-PV Pharmacovigilance or Drug Safety Professional · Inside Safety Watch
- RP-QA Clinical Quality Assurance Professional or GCP Auditor · Inside Terminal C
Questions in Ask the city
- Where does FDA say what counts as real-world evidence for a drug?
Data and systems · Oct 14, 2026
- What is the one thing new CRAs get wrong at their first visits?
Monitoring · Oct 13, 2026
- Which FDA guidance should I quote when a site asks why I am not doing 100 percent SDV?
Monitoring · Oct 13, 2026
- The EDC queries are piling up and the coordinator has stopped answering. What now?
Data and systems · Oct 13, 2026
- What do you do when a site is always 'too busy' for a visit?
Monitoring · Oct 13, 2026