Clinical data, end to end

The journey, in order

1. Step 1 · Collect

   CRF Studio

   Design the case report forms a protocol needs and enter data the way a site would.

   Evidence: Synthetic data

   • CRF.xl case study (Fred's own project): Turns protocol spreadsheets into CDASH forms and ODM-XML.
   • iMednet Python SDK case study (Fred's own project): Retrieves study metadata and records from an EDC's API.

2. Step 2 · Feel the consequences

   Protocol Drift

   Play a systems simulation of the friction between a protocol's specification and the messy data sites actually collect.

   Evidence: Synthetic data

   • Cadence Clinical case study (Fred's own project): Keeps study records in step with a protocol as it changes.
   • Clinical Trial Chaos (Arcade game): Sort clinical data into SDTM domains against the clock while an auditor watches.

3. Step 3 · Tabulate and analyse

   Study Data Pipeline

   Take DEMO-301, one fictional study, from its USDM definition through SDTM and ADaM to the tables of a study report, with every number traceable.

   Evidence: Synthetic data

   • Clinical Data Mapper case study (Fred's own project): Maps EDC records described by ODM metadata into SDTM domains.
   • Equipose case study (Fred's own project): Builds the reproducible randomization schedules that assign subjects to arms.

4. Step 4 · Govern the portfolio

   Clinical Data Platform

   See DEMO-301 as one of eight fictional studies in a sponsor's portfolio, with contracts, metrics and quality governed across them.

   Evidence: Synthetic data, Fictional vendors

   • Portfolio Dashboard
   • Operations Dashboards
   • Metrics Explorer
   • SQL Workbench
   • Data Governance
   • Platform Strategy

5. Step 5 · Read the decisions

   Study Data Pipeline case study

   The design decisions, practices and limits behind the pipeline, in one write-up.

   Evidence: Synthetic data

   • Modernizing a clinical data platform: a case study (planned, #2647)