Twelve modules of theory. Three months of doing the work.

Drug development phases, the roles of sponsor, CRO, investigator and IRB/EC, protocol structure, informed consent, and the thirteen GCP principles that sit behind every data decision.

21 CFR Part 11 and electronic records, ALCOA+ principles, audit trails, SOPs, the Data Management Plan, and what an inspector actually looks for.

Turning a protocol's schedule of assessments into forms, CDASH-aligned field naming, unique CRF annotation, and writing CRF completion guidelines sites will follow.

Database specification documents, form and visit configuration, dictionaries and code lists, user roles, and the checks that must pass before go-live.

Hands-on work in an electronic data capture environment: data entry, source data verification workflow, form freezing, protocol deviations and system reports.

Writing the Data Validation Plan, designing univariate and cross-form checks, programming and testing them, and running structured User Acceptance Testing.

Identifying discrepancies, writing queries a site can act on without ambiguity, tracking query ageing, escalation, and closing the loop with clean documentation.

Reconciling the safety database against clinical data, handling mismatches, and loading and reconciling central lab, ECG and IWRS vendor data.

MedDRA hierarchy and versioning for adverse events and medical history, WHO Drug Dictionary for concomitant medications, auto-coding, manual review and coding queries.

Why standards exist and how submissions use them: CDASH at collection, SDTM domains and structure, and where ADaM and define.xml fit in the chain.

Pre-lock checklists, soft lock versus hard lock, final QC and listings review, data transfer specifications, unblinding considerations and study archival.

Run a mock study end to end and document it, then rebuild your CV and LinkedIn around it and sit three mock interviews with written feedback.