Good Clinical Practice (GCP) Compliance Assessment

Has the study protocol been approved by an IRB/IEC before initiation?*

IRB approval required before any study activities

Are all protocol amendments submitted to IRB for approval before implementation?*

Do you submit continuing review reports to IRB at required intervals?*

Annual or more frequent as required by IRB

Is informed consent obtained from all subjects before any study procedures?*

Written informed consent is mandatory under GCP

Does the informed consent form include all required elements per ICH GCP?*

Study purpose, procedures, risks, benefits, alternatives, confidentiality, voluntary participation

Are subjects given adequate time to consider participation without coercion?*

Is re-consent obtained when new safety information becomes available?*

Is the principal investigator qualified by education, training, and experience?*

CVs and training records must be current

Are all study staff listed on Form FDA 1572 or equivalent?*

Do you maintain a delegation of authority log for all study tasks?*

Are GCP training records current for all study personnel?*

Initial and ongoing GCP training required

Is the Investigator Site File (ISF) complete and organized per GCP requirements?*

Essential documents must be maintained throughout study

Are source documents complete, contemporaneous, and attributable?*

Source data must support all data entered into CRFs

Do you maintain an audit trail for all study data corrections?*

Are Case Report Forms (CRFs) completed accurately and promptly?*

Data entry should occur as soon as possible after source document creation

Are data queries from sponsors/CROs addressed within required timeframes?*

Do you perform data verification against source documents?*

Source data verification (SDV) ensures data accuracy

Are all adverse events documented and reported per protocol requirements?*

AE documentation required from informed consent through study completion

Are serious adverse events (SAEs) reported to sponsor, IRB, and FDA within required timeframes?*

24 hours for life-threatening SAEs, 7 days for others

Do you have procedures for unblinding in emergencies?*