Starter contract

pharma_clinical_trial

17 rules · plain YAML · starts in observation mode

OpenDQV Cloud starter template (v0.1) — your tenant inherits this baseline. First customer edit creates v1.0 in your audit trail; pin by yaml_hash for replay. Pharmaceutical clinical trial subject record validation. Enforces ICH-GCP E6(R2) Good Clinical Practice requirements at the point of write. Validates ClinicalTrials.gov protocol identifiers (NCT format), trial phase classification, adverse event severity coding aligned with MedDRA conventions, informed consent status, and dose unit standardisation. Prevents incomplete or miscoded trial data from entering regulatory submission pipelines where FDA 21 CFR Part 11 and EMA CPMP/ICH/135/95 compliance requires audit-ready, complete records.

These are starting points you own. Every rule below ships in the trial, starts in observation mode, and is yours to read, edit, or delete from day one. Rules that reference a lookup list (lookup_file) validate against reference data you control in your tenant.
Rules as at 29 August 2026 — starting points you own, not a maintained regulatory feed. We correct errors in these samples; tracking regulatory change in your active contracts is yours.

Rule	Field	Severity	What it enforces (the message your team sees)
subject_id_required	subject_id	error	subject_id is required
subject_id_unique	subject_id	error	subject_id must be unique within this batch — duplicate subject identifiers indicate a data integrity failure (ICH-GCP E6(R2) 4.11). Note: OpenDQV validates uniqueness within the input payload only; cross-batch uniqueness against the trial master file is the responsibility of the upstream EDC system.
site_id_required	site_id	error	site_id is required
protocol_id_required	protocol_id	error	protocol_id is required
protocol_id_format	protocol_id	warning	protocol_id does not match ClinicalTrials.gov format (NCT followed by 8 digits, e.g. NCT04470427) — verify if using EudraCT or other registry
trial_phase_values	trial_phase	error	trial_phase must be one of: phase_1, phase_1_2, phase_2, phase_2_3, phase_3, phase_4, observational, expanded_access
visit_date_format	visit_date	error	visit_date must be a valid date (YYYY-MM-DD)
age_range	age	error	age must be between 18 and 100
gender_required	gender	error	gender is required
gender_values	gender	error	gender must be one of: male, female, non_binary, not_disclosed, unknown
informed_consent_values	informed_consent	error	informed_consent must be one of: yes, pending, withdrawn, not_required (ICH-GCP E6(R2) 4.8 — informed consent is mandatory before any trial procedure)
dose_mg_min	dose_mg	error	dose_mg must be >= 0
dose_unit_values	dose_unit	error	dose_unit must be one of: mg, mcg, g, ml, iu, units, mg_kg, mcg_kg
adverse_event_code_required	adverse_event_code	warning	adverse_event_code should be provided if applicable
adverse_event_severity_values	adverse_event_severity	warning	adverse_event_severity must be one of: none, mild, moderate, severe, life_threatening, fatal (MedDRA CTCAE grading — Grade 4/5 triggers SAE reporting obligations)
collection_date_format	collection_date	error	collection_date must be a valid date (YYYY-MM-DD)
investigator_id_required	investigator_id	error	investigator_id is required

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