DFD — Clinical Trial Data Capture
Phase III electronic data capture from site eCRF to database lock, separating the identifiable site zone from the pseudonymised sponsor EDC and exposing the subject-key read that is the trial's re-identification path.
Make it your own.
title "Phase III trial — data capture to lock"
level 1
entity "Investigator site"
entity "Central laboratory"
entity "Data monitoring committee"
entity "Regulator (FDA)"
process 1 "Capture eCRF"
process 2 "Pseudonymise and key"
process 3 "Run edit checks"
process 4 "Raise and resolve query"
process 5 "Reconcile lab data"
process 6 "Lock and export SDTM"
process 7 "Report to DMC"
store D1 "eCRF database"
store D2 "Subject identity key"
store D3 "Query log"
store D4 "Lab result store"
store D5 "Audit trail (21 CFR 11)"
boundary "Site zone (identifiable)" { "Investigator site", 1, 2, D2 }
boundary "Sponsor EDC (pseudonymised)" { 3, 4, 5, 6, 7, D1, D3, D4, D5 }
boundary "External review" { "Data monitoring committee", "Regulator (FDA)" }
"Investigator site" -> 1 : "visit data + adverse events"
1 -> 2 : "subject name + date of birth"
2 -> D2 : "pseudonym mapping"
2 -> D1 : "pseudonymised eCRF"
D1 -> 3 : "new + changed fields"
3 -> D3 : "edit-check failure"
D3 -> 4 : "open queries (312)"
4 -> "Investigator site" : "query for clarification"
"Investigator site" -> 4 : "query response"
4 -> D1 : "corrected value"
"Central laboratory" -> 5 : "LOINC lab results"
D2 -> 5 : "accession link"
5 -> D4 : "lab panel"
D1 -> 6 : "clean eCRF"
D4 -> 6 : "reconciled labs"
6 -> D5 : "lock signature"
6 -> "Regulator (FDA)" : "SDTM submission"
D1 -> 7 : "safety data"
D5 -> 7 : "change history"
7 -> "Data monitoring committee" : "interim safety report"