IP & Device Accountability
This log should reconcile product received, dispensed, returned, destroyed, lost, or remaining.
What is an investigational product accountability log?
he monitor’s role is to verify quality and compliance, but this person remains responsible for site conduct.
Who is the Principal Investigator?
These criteria define who may participate in the study.
What are inclusion and exclusion criteria?
This federal rule governs protection of identifiable health information in many clinical research settings.
What is HIPAA?
This visit confirms that study activities are ending appropriately and records are ready for retention or transfer.
What is a closeout visit?
This is the concern when a dose was administered but not recorded on the accountability log.
What is unreconciled investigational product?
These records are the original places where study data are first captured or verified.
What are source documents?
This person must sign and date the consent form to document voluntary agreement to participate.
Who is the participant / legally authorized representative?
When a required study procedure is missed, performed outside the allowed window, or completed incorrectly, this should usually be documented.
What is a protocol deviation?
This protocol tool shows which procedures are required at each study visit.
What is the schedule of events / schedule of assessments?
Temperature excursions, missing calibration records, and incomplete receipt logs most directly threaten this.
What is investigational product integrity / device reliability?
In ALCOA-C, this term means it should be clear who created or changed a research record.
What is attributable?
This document or process may be required when a child can understand the study but is not old enough to provide legal consent.
What is assent?
This section of the protocol defines which participants may enter the study and which must be excluded.
What are inclusion and exclusion criteria?
This group reviews research to protect participant rights, safety, and welfare before and during the study.
What is the IRB?
This person should be available during an inspection to answer questions about medical oversight and trial conduct at the site.
Who is the Principal Investigator?
This electronic record feature tracks who changed data, what was changed, when it changed, and why.
What is an audit trail?
This document is the primary source for required study procedures, visit windows, eligibility criteria, and endpoint assessments.
What is the protocol?
This record shows that study staff were trained on the protocol, amendments, procedures, or study systems before performing related tasks.
What is the training log?
Repeated deviations from the same root cause should trigger this type of structured response.
What is a CAPA plan?
This document authorizes the sponsor to begin clinical investigation of an investigational drug in humans under FDA oversight.
What is an IND?
This document is issued by FDA investigators at the end of an inspection when they identify inspectional observations.
What is Form FDA 483?
This term describes an adverse event that is unexpected, serious, and related or possibly related to the investigational product.
UPRITSO
This federal form is used in FDA-regulated drug and biologic studies to document investigator commitments and site information.
What is Form FDA 1572?
This process confirms that investigational product or study supplies received, used, returned, destroyed, or remaining can be reconciled.
What is accountability?