Research Study Start-Up (40%) Flashcards
What is the purpose of a research study protocol?
To outline the trial’s objectives, design, methodology, and organization to ensure participant safety and data integrity.
What is the role of an IRB/IEC in study start-up?
To review, approve, and monitor clinical trials to protect the rights and welfare of human subjects.
What are key elements of an informed consent document?
-Study purpose
-Potential risks and benefits
-Participant rights, including the right to withdraw
-Confidentiality of participant data
What is required in a delegation log?
A record of all personnel delegated trial-related tasks by the investigator.
What is the role of the sponsor in research study start-up?
-Ensure proper protocol design
-Provide funding and resources
-Maintain regulatory compliance
What is an IND and what is it used for?
An Investigational New Drug application (IND) is submitted to the FDA to request approval for testing a new drug in humans.
What is an IDE and when is it required?
An Investigational Device Exemption (IDE) is required when testing a significant-risk medical device in a clinical trial.
What are the key ethical concepts that guide clinical research?
-Nuremberg Code
-Belmont Report
-Declaration of Helsinki
What is the purpose of SOPs in clinical research?
Standard Operating Procedures ensure consistency, regulatory compliance, and participant safety in clinical trials.
What is the purpose of expedited review in clinical trials?
Allows IRBs to approve minimal-risk studies more efficiently.
What is an emergency use research protocol?
A protocol designed for the urgent administration of an investigational product in life-threatening situations without IRB/IEC pre-approval.
What special protections apply to vulnerable populations in clinical trials?
Children: Parental consent and child assent are required. Research must minimize risk and offer potential benefits.
Prisoners: Additional safeguards to ensure participation is voluntary and benefits outweigh risks.
Pregnant Women: Research must minimize risk to both the mother and fetus. Participation requires clear benefits for either or both parties.
Human Fetuses and Neonates: Research must present minimal risk unless benefiting the fetus or neonate. Obtain consent from the mother (and father if required). Include a qualified pediatric expert.
What is the primary goal of a Case Report Form (CRF)?
To capture the data needed to answer the research questions of a clinical trial, including both safety and efficacy endpoints.
What elements are required in a case report form (CRF)?
A CRF must contain:
- Participant demographics (e.g., age, sex, medical history)
- Study data points (e.g., lab values, test results)
- Treatment administration details
- Adverse event documentation with severity, onset, outcome, and investigator assessment of causality
- Any deviations from the protocol
What is the purpose of FDA Forms 3454 and 3455?
FDA Form 3454 certifies no financial conflicts exist.
FDA Form 3455 discloses any financial conflicts.
What is the purpose of the Investigator’s Brochure (IB)?
The IB is a comprehensive document that provides clinical investigators and IRBs with detailed information about the investigational product. It includes:
-Preclinical and clinical trial data
-Dosing and administration guidelines
-Known side effects and risks
-Safety monitoring recommendations
-Instructions for handling and storing the product
What is required for site selection in a clinical trial?
- Adequate facilities and equipment for trial procedures
- Access to an appropriate participant population
- Qualified staff trained in Good Clinical Practice (GCP)
- A clear record of compliance with regulatory requirements
- Demonstrated ability to recruit and retain participants
- Effective data management and reporting capabilities
What is the purpose of FDA Form 1572?
To ensure investigators agree to follow GCP, protocol requirements, and protect participant safety.
What are examples of an essential document in clinical research?
Protocol
Informed consent form
Case report forms
Financial disclosure documents
What must investigators submit to clinicaltrials.gov?
Study registration information
Study results within 12 months of primary completion.
Final study outcomes, including primary and secondary results.
Adverse event summary, including frequency and severity
Summary of participant demographics
What is a Significant Risk Device study?
A clinical trial involving a device that presents a serious risk to the participant’s health or safety.
What is a Feasibility Study in Medical Device research
An early-stage study designed to evaluate device functionality and initial safety.
What is a Pivotal Study in medical device research?
A late-stage study designed to gather definitive evidence of the device’s safety and effectiveness.
What is the purpose of an FDA Form 482?
To notify a site of an FDA inspection.
What is the purpose of FDA Form 483?
To document inspection observations of potential regulatory violations.
What is the purpose of a protocol amendment?
To document and communicate changes to the approved protocol.
What is a protocol deviation?
Any unapproved change from the approved study protocol.
What is the purpose of a site initiation visit (SIV)?
To train study staff on protocol requirements and confirm site readiness.
What must be included in financial disclosure records?
-Investigator’s equity interests
-Significant payments made by sponsors
What is the purpose of an Investigator Agreement in device trials?
To confirm the investigator’s commitment to follow the protocol and ensure participant safety.
What is the purpose of a monitoring plan in clinical trials?
To define how site visits, data verification, and compliance checks will be conducted.
What are Clinical Investigator Disqualification and Debarment?
- Disqualification: The FDA may disqualify an investigator if they have repeatedly or deliberately failed to comply with applicable regulatory requirements or submitted false information.
- Debarment: The FDA may prohibit an investigator from participating in clinical trials if they are convicted of certain felonies or offenses related to drug development or public health.
What steps must be taken when disqualification or debarment occurs?
-The investigator must stop all involvement in clinical trials
-Sponsors must be informed to prevent further participation
-Regulatory authorities must be updated to ensure ongoing compliance
What is a significant equity interest in clinical research?
An ownership stake in the investigational product’s manufacturer exceeding $50,000.
