Clinical QA
The term that refers to the systematic documentation and archiving of all essential documents related to the conduct of a clinical trial.
What is Record Keeping or Document Management?
The term that refers to changes made to the study protocol after the initiation of a clinical trial to address unforeseen issues or modify study procedures.
What are Protocol Amendments?
The initial phase of drug development where researchers identify and validate potential drug targets.
What is Drug Discovery?
The independent committees responsible for periodically reviewing the safety and efficacy data from a clinical trial and making recommendations regarding its continuation or termination?
What are Data Monitoring Committees (DMCs) or Data Safety Monitoring Boards (DSMBs)?
The term that describes the study of the physiological effects of drugs and their mechanisms of action.
What is Pharmacodynamics?
The approximate timeframe for the entire drug development process, from discovery to regulatory approval.
What is 10 to 15 years?
The primary outcome measured in a clinical trial to determine the efficacy of a drug
What is a Clinical Endpoint?
The phase of clinical trial in drug development conducted in up to a few hundred subjects that is designed to determine if the new treatment has sufficiently promising efficacy to warrant further investigation
What is a Phase 2 trial?
The term that describes the completeness, accuracy, and reliability of data collected during a clinical trial.
What is Data Integrity?
The term describing the biochemical transformation of drugs into metabolites by enzymes in the body.
What is Drug Metabolism?
The term that refers to the process of ensuring that data collected during clinical trials is accurate, complete, and verifiable.
What is data validation?
The type of clinical trial that includes a control group receiving an inactive substance to evaluate the true effect of a drug.
What is a Placebo-Controlled Trial?
The term that describes the study of how the body absorbs, distributes, metabolizes, and excretes drugs.
What is Pharmacokinetics?
Responsible for the initiation, management, and financing of a clinical trial, ensuring compliance with GCP, and submitting regulatory documents to health authorities.
Who is the Sponsor?
Term describing the fraction of an administered dose of a drug that reaches systemic circulation unchanged.
What is Bioavailability?
Implementing strategies for ongoing evaluation and improvement of clinical practices, based on feedback, audit findings, and best practices.
What is continuous improvement?
The document that provides comprehensive information about an investigational drug to investigators and regulatory authorities.
What is an Investigator's Brochure (IB)?
The term that describes the stage of drug development where experimental compounds are tested in laboratory models and animal studies to assess safety and efficacy.
What is Preclinical Testing?
The process that involves regulatory authorities conducting audits or inspections of clinical trial sites, sponsor facilities, or CROs to ensure compliance with GCP and regulatory requirements?
What are Regulatory Inspections or Audits?
The process of assessing and monitoring the safety profile of a drug throughout its lifecycle.
What is Drug Safety Surveillance?
A systematic approach used in quality management systems to address and rectify issues, non-conformities, and deficiencies identified during audits, inspections, or other quality control processes.
What is corrective and preventative action (CAPA)?
The term that describes the process of ensuring that clinical trial participants meet specific criteria for inclusion in the study.
What is patient screening.
The chemical-based compounds that have pharmacological activity mainly used with combination of other ingredients to diagnose, cure, mitigate, and treat the disease.
What is Active Pharmaceutical Ingredient (API)?
According to 21 CFR Part 312, the primary purpose of submitting an Investigational New Drug (IND) application to the FDA.
What is to demonstrate the safety and efficacy of an investigational drug in humans and obtain permission to conduct clinical trials?
The type of clinical trial that is conducted after a drug has been approved for marketing to further evaluate its safety and effectiveness in real-world settings.
What are Phase 4 Clinical Trials or Post-Marketing Surveillance Studies?