Research Study Start-Up (40%)

Question 1

What is the purpose of a research study protocol?

Answer 1

To outline the trial’s objectives, design, methodology, and organization to ensure participant safety and data integrity.

Question 2

What is the role of an IRB/IEC in study start-up?

Answer 2

To review, approve, and monitor clinical trials to protect the rights and welfare of human subjects.

Question 3

What are key elements of an informed consent document?

Answer 3

-Study purpose
-Potential risks and benefits
-Participant rights, including the right to withdraw
-Confidentiality of participant data

Question 4

What is required in a delegation log?

Answer 4

A record of all personnel delegated trial-related tasks by the investigator.

Question 5

What is the role of the sponsor in research study start-up?

Answer 5

-Ensure proper protocol design
-Provide funding and resources
-Maintain regulatory compliance

Question 6

What is an IND and what is it used for?

Answer 6

An Investigational New Drug application (IND) is submitted to the FDA to request approval for testing a new drug in humans.

Question 7

What is an IDE and when is it required?

Answer 7

An Investigational Device Exemption (IDE) is required when testing a significant-risk medical device in a clinical trial.

Question 8

What are the key ethical concepts that guide clinical research?

Answer 8

-Nuremberg Code
-Belmont Report
-Declaration of Helsinki

Question 9

What is the purpose of SOPs in clinical research?

Answer 9

Standard Operating Procedures ensure consistency, regulatory compliance, and participant safety in clinical trials.

Question 10

What is the purpose of expedited review in clinical trials?

Answer 10

Allows IRBs to approve minimal-risk studies more efficiently.

Question 11

What is an emergency use research protocol?

Answer 11

A protocol designed for the urgent administration of an investigational product in life-threatening situations without IRB/IEC pre-approval.

Question 12

What special protections apply to vulnerable populations in clinical trials?

Answer 12

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.

Question 13

What is the primary goal of a Case Report Form (CRF)?

Answer 13

To capture the data needed to answer the research questions of a clinical trial, including both safety and efficacy endpoints.

Question 14

What elements are required in a case report form (CRF)?

Answer 14

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

Question 15

What is the purpose of FDA Forms 3454 and 3455?

Answer 15

FDA Form 3454 certifies no financial conflicts exist.

FDA Form 3455 discloses any financial conflicts.

Question 16

What is the purpose of the Investigator’s Brochure (IB)?

Answer 16

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

Question 17

What is required for site selection in a clinical trial?

Answer 17

• 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

Question 18

What is the purpose of FDA Form 1572?

Answer 18

To ensure investigators agree to follow GCP, protocol requirements, and protect participant safety.

Question 19

What are examples of an essential document in clinical research?

Answer 19

Protocol

Informed consent form

Case report forms

Financial disclosure documents

Question 20

What must investigators submit to clinicaltrials.gov?

Answer 20

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

Question 21

What is a Significant Risk Device study?

Answer 21

A clinical trial involving a device that presents a serious risk to the participant’s health or safety.

Question 22

What is a Feasibility Study in Medical Device research

Answer 22

An early-stage study designed to evaluate device functionality and initial safety.

Question 23

What is a Pivotal Study in medical device research?

Answer 23

A late-stage study designed to gather definitive evidence of the device’s safety and effectiveness.

Question 24

What is the purpose of an FDA Form 482?

Answer 24

To notify a site of an FDA inspection.

Question 25

What is the purpose of FDA Form 483?

Answer 25

To document inspection observations of potential regulatory violations.

Question 26

What is the purpose of a protocol amendment?

Answer 26

To document and communicate changes to the approved protocol.

Question 27

What is a protocol deviation?

Answer 27

Any unapproved change from the approved study protocol.

Question 28

What is the purpose of a site initiation visit (SIV)?

Answer 28

To train study staff on protocol requirements and confirm site readiness.

Question 29

What must be included in financial disclosure records?

Answer 29

-Investigator’s equity interests -Significant payments made by sponsors

Question 30

What is the purpose of an Investigator Agreement in device trials?

Answer 30

To confirm the investigator's commitment to follow the protocol and ensure participant safety.

Question 31

What is the purpose of a monitoring plan in clinical trials?

Answer 31

To define how site visits, data verification, and compliance checks will be conducted.

Question 32

What are Clinical Investigator Disqualification and Debarment?

Answer 32

- 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.

Question 33

What steps must be taken when disqualification or debarment occurs?

Answer 33

-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

Question 34

What is a significant equity interest in clinical research?

Answer 34

An ownership stake in the investigational product’s manufacturer exceeding $50,000.