ACRP ICH Flashcards Challenge

Who is responsible for providing the trial protocol - Answer- The Sponsor Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced are called..? - Answer- Essential documents All information in original records and certified copies of original records of critical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial are called..? - Answer- Source Data One of the primary purposes of a Phase I study is to determine the metabolic and pharmacologic action of the drug in humans. - Answer- True The purpose of the IRB/IEC is to project subject safety. - Answer- True Who is ultimately responsible for SDV? - Answer- The Monitor Most typical study, investigates human pharmacology. It is the initial administration of an investigational new drug into humans. It is most commonly done in healthy subjects. Which phase if this? - Answer- Phase I What is the minimum number of members on an IRB/IEC? - Answer- 5 The purpose of ICH-GCP is to standardize the design, conduct, recording and reporting of clinical trials. - Answer- True The purpose of the DSMB is to assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints. - Answer- True The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as.. - Answer- Informed Consent The Declaration of Helsinki was developed by... - Answer- The World Medical Association Which phase determines therapeutic benefit and is usually done in a larger, specific population? - Answer- Phase III An individual, company, institution or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial is called the.... - Answer- Sponsor