Research Study Closure (15%) Flashcards
What is the purpose of a study closeout visit?
To verify study documentation, resolve outstanding queries, and ensure investigational product accountability.
What essential documents must be verified during a study closeout visit?
- Informed consent forms
-Protocol and amendments
-Case report forms (CRFs)
-Delegation logs
What is the purpose of resolving monitoring queries during a closeout visit?
To ensure all data discrepancies and incomplete documentation are addressed before study closure.
What steps must be taken to account for investigational products during study closure?
-Verify product return or destruction
-Document product inventory
-Ensure appropriate storage until disposal
What is the purpose of a research study audit?
To ensure compliance with protocols, SOPs, and regulatory requirements.
What essential documents must be maintained for audit readiness?
-Source documents
-Informed consent records
-Study correspondence
-Protocol deviation records
What is the role of Quality Control (QC) in research study closure?
To review data accuracy, completeness, and compliance with protocols.
What is the role of Quality Assurance (QA) in research study closure?
To conduct independent assessments that ensure study integrity and compliance.
What should sites prepare for an FDA inspection during study closure?
-Investigator site file (ISF)
-Drug accountability records
-Adverse event reports
-IRB/IEC correspondence
What is included in a study closure report submitted to the IRB?
-Study completion date
-Final participant numbers
-Summary of protocol deviations
-Confirmation that data collection is complete
What must be included in a final report to the study sponsor?
-Summary of study outcomes
-Final safety data
-Details on investigational product accountability
What regulatory authorities require a final study report submission?
FDA
EMA
Health Canada (if applicable)
What information must be reported to ClinicalTrials.gov at study closure?
- Study completion status
- Final results (if applicable)
- Summary of adverse events
What is the purpose of study termination reporting?
To notify stakeholders that the study has ended prematurely and provide reasons for termination.
What documentation should be archived after study closure?
- ICFs
- Case report forms (CRFs)
- AE documentation
- Study correspondence
What are the regulatory requirements for study record retention?
Records must be retained for 2 years following drug approval or as required by applicable regulations.
What steps must be taken when archiving study records?
Organize documents by category
Ensure secure storage
Assign designated personnel for retrieval access
What must be included in a final report to regulatory authorities?
- Study results
- Summary of participant data
- Safety reporting summary
What are key considerations when preparing for a regulatory inspection during closure?
- Ensure all essential documents are complete, IP records are updated, and all PDs are documented
What is the purpose of a data lock at study closure?
To finalize and secure study data for analysis, ensuring no further changes are made.
