Clinical trial phase 2 - Study guides, Class notes & Summaries

ACRP CCRC Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A Q: The protocol and protocol summary have been submitted to a central IRB/IEC for review/approval by the CRO prior to the investigators' meeting. Following the meeting, the entry criteria are altered to facilitate the recruitment and retention of eligible subject. Prior to trial start-up, the regulatory binder must include: 1.An IRB/IEC letter of approval for the amended protocol 2.An IRB/IEC ...

1. Active Pharmaceutical Ingredients (API) or bulk drug substance may be discovered or obtained by: I. Synthetic biotechnology II. Isolation from natural sources III. Serendipitous new drug effect discovery A. I only B. III only C. I and II D. II and III E. I, II and III correct answers E. I, II and III 2. Rx product life cycle phases that involves regulatory submission for additional dosage forms or new therapeutic indications A. Discovery B. Development C. Commercialization D. T...

Pharmacology 1st Semester Nursing STLCC Exam With Complete Solution 2024. At what phase during drug evaluation does the drug first hit the clinical market? A. Preclinical Trial B. Phase I C. Phase II D. Phase III E. Phase IV - ANSWER D. Phase III During Preclinical Trials the chemical is tested in a lab on animals to determine its therapeutic and toxic effects. During Phase I the drug is then tested on human volunteers that are typically compensated. During Phase II the drug is teste...

Pharmacology 1st Semester Nursing STLCC Exam With Complete Solution 2024. At what phase during drug evaluation does the drug first hit the clinical market? A. Preclinical Trial B. Phase I C. Phase II D. Phase III E. Phase IV - ANSWER D. Phase III During Preclinical Trials the chemical is tested in a lab on animals to determine its therapeutic and toxic effects. During Phase I the drug is then tested on human volunteers that are typically compensated. During Phase II the drug is teste...

Which of the following is a disclosure of financial interests form? FDA Form 3455 Which of the following is a certification of financial interest form? FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Investigational New Drug Application (1571) In the top right corner, form have OMB number. Wh...

The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers is: a. phase 1 b. phase 2 c. phase 3 d. phase 4 Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (11T) c. Post market device registries d. outcome and health services research Who is ultimately responsible for all aspects of the research conducted at a site? a. IRB b. sponsor c. principal investigator d. clinic...

In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your approved drugs in a new combination - correct answer C) You intend to collect blood sampl...

US RAC Review Questions and Answers RAPS Modules 2024 with complete solution In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your approved dru...

US RAC Review Questions RAPS Modules 2024 with complete solution In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your approved drugs in a new ...

US RAC Review Questions And Answers 2024 RAPS Modules Updated with Complete Solution. In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your appr...