Research Study Implementation (45%) Flashcards
(40 cards)
What is the purpose of Standard Operating Procedures (SOPs) in clinical research?
To ensure consistent, compliant, and effective conduct of research studies.
What are the key responsibilities of an IRB/IEC in research study implementation?
- Review and approve research protocols
- Monitor ongoing studies
- Ensure participant safety
What must be included in a continuing review submission to the IRB/IEC?
Study progress
Enrollment status
Summary of adverse events and protocol deviations
What is a protocol amendment?
A change to the study design, procedures, or documentation that must be approved by the IRB/IEC and regulatory authorities.
What are the key elements of a protocol deviation report?
-Description of the deviation
-Date of occurrence
-Corrective actions taken
What is the purpose of FDA Form 3454?
To certify that no financial conflicts of interest exist for clinical investigators.
What is the purpose of FDA Form 3455?
To disclose financial conflicts of interest for clinical investigators.
What is a sponsor’s responsibility regarding investigational product accountability?
Tracking shipment and receipt
Ensuring appropriate storage
Verifying product use according to protocol
What steps are required to dispense investigational products at a study site?
Confirm participant eligibility
Record product details (e.g., lot number, expiration)
Document administration in participant records
What documentation must be maintained for investigational product accountability?
Shipping records
Dispensing logs
Return and disposal records
What is the purpose of randomization in clinical trials?
To reduce bias and ensure comparable treatment groups.
What is an adverse event (AE)?
Any unwanted medical occurrence in a participant during a clinical trial.
How should Adverse Events be documented?
Description of the event
Date of onset and resolution
Relationship to the investigational product
Treatment administered
What is a serious adverse event (SAE)?
An adverse event that results in death, life-threatening harm, hospitalization, disability, or significant medical intervention.
What is an unanticipated problem in a clinical trial?
An unexpected event that may pose risks to participants or affect study integrity.
How are serious adverse events reported to the FDA?
Life-threatening SAEs: Report within 7 days
Other SAEs: Report within 15 days
What is the purpose of MedWatch Form 3500?
For voluntary reporting of adverse events by healthcare providers and consumers.
What is the purpose of MedWatch Form 3500A?
For mandatory reporting of adverse events by manufacturers, distributors, and facilities.
What is research misconduct?
Any act of fabrication, falsification, or plagiarism in research.
What steps must an investigator take when identifying research misconduct?
Document findings
Notify the sponsor and regulatory authorities
Ensure participant safety
What must be documented when subjects withdraw from a study?
Reason for withdrawal
Follow-up care provided
Impact on data collection
What are the investigator’s responsibilities for subject safety?
Monitor participants for adverse effects
Report safety concerns to the sponsor and IRB
Adjust treatment as necessary
What must be included in informed consent documentation?
Study purpose
Potential risks and benefits
Voluntary participation and withdrawal rights
What is the purpose of a subject eligibility checklist?
To confirm that participants meet all inclusion and exclusion criteria.
