9  Regulatory Framework & Roles

9.1 What “Compliance” Means Operationally

Compliance is demonstrated through: - Correct approvals before study activities occur - Accurate delegation and training for staff performing trial tasks - Controlled versions of essential documents - Traceable decisions and corrective actions (audit trail)

9.2 CRA Role vs Site Role (Quick Map)

Area	Site Owns	CRA Verifies / Oversees
IRB submissions	Submission content/timing	Approval validity; no activity before approval
Informed consent	Consent process + documentation	Version control; process adherence; documentation completeness
Delegation	Assigning tasks	Alignment to qualifications + training
Essential docs	Maintenance of site reg binder	Completeness; consistency; filing timeliness
TMF	Sponsor/CRO filing	Completeness/QC; reconciliation with site docs