Inside Data Works

What this team does

Builds the database the sites enter data into, and checks what comes in.

Sends queries when something looks wrong and closes them when it is fixed.

Gets the data clean enough to lock, then analyses it.

A day here

1. 8:00Overnight checks ran. 140 new queries, most of them the same date format problem.
2. 9:30Write one message to all sites instead of 140 queries. The CRAs help spread it.
3. 11:00A protocol amendment adds a new form. You build it and test it before Friday.
4. 14:00The statistician asks why lab values from one site look ten times higher. Wrong unit.
5. 16:30Lock is in six weeks. You count what is left and send the list to the trial manager.

Roles, junior to senior

• Clinical data associate
• Clinical data manager
• EDC or database programmer
• Statistical programmer
• Biostatistician

1. Clinical data associateReviewing data, raising queries and following up with sites.Clinical Data ManagerSource Documentation and Data IntegrityClinical Systems and Data Workflow
2. Clinical data managerThe data plan, checks and cleaning for one study through to lock.Clinical Data ManagerClinical Systems and Data WorkflowSource Documentation and Data IntegrityQuality
3. EDC or database programmerBuilding the forms and the automatic checks sites see.Clinical Data ManagerClinical Systems and Data Workflow
4. Statistical programmerTurning clean data into the tables and listings for the report.Clinical Systems and Data WorkflowSource Documentation and Data Integrity
5. BiostatisticianHow the study answers its question: sample size, analysis plan and results.Protocol InterpretationClinical Systems and Data Workflow

Who they talk to every day

• Site 204
• Terminal C
• Project Tower
• Safety Watch
• Central Lab

Words you will hear

EDC

Electronic data capture. The system sites type study data into.

CRF

Case report form. The pages, now screens, where each visit's data goes.

Edit check

A rule in the system that flags a value that cannot be right.

Query

A question to the site about one data point.

Data cleaning

Finding and fixing wrong or missing data before lock.

SAP

Statistical analysis plan. How the results will be worked out, written before you look.

CDISC

Shared formats for study data so regulators can read it the same way every time.

Common moves in and out

People come from site data entry, science degrees, coding and statistics.

From here they move to data leadership, programming, clinical systems or risk-based monitoring.