Regulations and Guidelines
This U.S. federal agency is responsible for ensuring the safety and efficacy of drugs and medical devices.
What is the FDA (Food and Drug Administration)?
This essential document outlines the objectives, design, methodology, and organization of a trial.
What is a protocol?
This phase involves the initial introduction of a new drug into humans.
What is Phase I?
This person is primarily responsible for the conduct of the clinical trial at the site.
Who is the Principal Investigator (PI)?
This term refers to the group of participants who receive the experimental treatment in a clinical trial.
What is the treatment group?
This international guideline provides a unified standard for designing, conducting, recording, and reporting trials.
What is ICH-GCP (International Conference on Harmonisation - Good Clinical Practice)?
This is a log used by CRAs to track study-specific tasks and their completion status.
What is a monitoring plan?
This phase is conducted after the drug has been approved for consumer sale.
What is Phase IV?
This professional oversees the progress of a clinical trial and ensures compliance with the protocol.
What is a Clinical Research Associate (CRA)?
This is a substance with no therapeutic effect used as a control in testing new drugs.
What is a placebo?
The U.S. regulation that protects human subjects in research is known as this.
What is the Common Rule?
This document ensures that a clinical trial can be recreated based on the data provided.
What is a case report form (CRF)?
This phase involves large-scale testing to confirm effectiveness, monitor side effects, and compare it to commonly used treatments.
What is Phase III?
This team member ensures that all regulatory requirements are met and manages communications with regulatory authorities.
What is a Regulatory Affairs Specialist?
This is a set of criteria that determines who is eligible to participate in a clinical trial.
What are inclusion criteria?
This document is required by the FDA before starting a clinical trial and involves reviewing the protocol for safety.
What is an IND (Investigational New Drug application)?
This binder contains all essential documents required before the initiation of a clinical trial at a site.
What is an Investigator Site File (ISF)?
This phase is designed to test a drug’s safety in individuals with a specific condition.
What is Phase IIa?
This person is responsible for the overall design, conduct, and management of the clinical trial.
Who is the Clinical Trial Manager (CTM)?
This document ensures that a participant has been fully informed about the trial and agrees to participate.
What is informed consent?
This European regulation came into effect in 2018 to enhance the protection of personal data.
What is GDPR (General Data Protection Regulation)?
These reports are submitted annually to regulatory authorities to provide updates on the status of the clinical trial.
What are Annual Progress Reports (APRs)?
This phase focuses on the effectiveness of the drug and further evaluates its safety.
What is Phase II?
This role involves statistical analysis and interpretation of clinical trial data.
What is a Biostatistician?
This term refers to the random allocation of participants to different groups in a clinical trial.
What is randomization?