1571 - Study guides, Class notes & Summaries

1571 - ANSWER IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 - ANSWER Investigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP Study Type - Placebo control - ANSWER in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a placebo Study Type - Active control - ANSWER Done when use of ...

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

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. What does it stand f...

SOCRA Practice Test Questions with 100% Verified Correct Answers Which of the following is a disclosure of financial interests form? - Correct Answer FDA Form 3455 Which of the following is a certification of financial interest form? - Correct Answer FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - Correct Answer FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug tria...

What must you file before conducting human clinical trials with an experimental drug? Correct Answer IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct Answer Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant changes in investigators conducting clinical trials un...

SOCRA Practice Test 100% Solved Which of the following is a disclosure of financial interests form? - ANSFDA Form 3455 Which of the following is a certification of financial interest form? - ANSFDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANSFDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ANSInvestigational New Drug Application (1571) In the top right cor...

SOCRA Practice Test solved 100% Which of the following is a disclosure of financial interests form? -Correct Answer-FDA Form 3455 Which of the following is a certification of financial interest form? -Correct Answer-FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: -Correct Answer-FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial -Correct Answer-Investigational New...

Which of the following is a disclosure of financial interests form? - Which of the following is a certification of financial interest form? - If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - Investigational New Drug Application In the top right corner, form have OMB number. What does it stand for? - The form, which is submitted to the FD...

RAC EXAM QUESTIONS WITH 100% CORRECT ANSWERS A deficiency letter may be issued to a company during a Biologics License Application (BLA) review for which of the following? - Answer- Clinical testing did not include enough subjects Company X is developing marketing materials for a Class II medical device known as "Y." In one marketing piece, the company talks about the clinical data supporting the device's marketing. Which of the following statements is illegal and should NOT be inc...

When isn't an IND application needed? - ANSWER-IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) - ANSWER--FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependence and abuse...