An astute monitor discovers that a site is using nebulized albuterol rather than the inhaler...

In this scenario, the site hasdeviated from the approved study protocolby using adifferent formulation (nebulized albuterol instead of inhaler). This is considered aprotocol deviation or violation, depending on study definitions.

PerGCDMP (Chapter: Data Validation and Cleaning)andICH E6(R2), Data Managers are responsible for ensuring that all protocol deviations affecting data integrity or subject safety areaccurately captured and documentedwithin the clinical database. The appropriate action is toissue a data queryprompting the site to record the deviation in the designated section (e.g., “Protocol Deviations” CRF).

Option A:Incorrect — it affects data comparability.

Option B:Escalation to the Ethics Committee is handled by the sponsor, not the Data Manager.

Option C:Updating the CRF guidelines is premature; first, the deviation must be logged and assessed.

Therefore,option D (Query the site to enter a Protocol Violation)is the correct and compliant action.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Data Validation and Cleaning, Section 6.2 – Query Management and Protocol Deviations

ICH E6(R2) GCP, Section 4.5 – Compliance with Protocol

FDA Guidance for Industry: Oversight of Clinical Investigations — Compliance and Protocol Deviation Reporting