| PAGE 1: Please identify a clinical protocol from any source. If you can attach it to your submission as a word document, it is great. If not, summarize your comments on the advantages and disadvantages of the study design and outcome measures. If you have a reference book that describes protocols, you can read it as background material. If you find a good source, mention it in the discussion board for others to use too. PAGE 2 /3 please your list link https://www.ecfr.gov/cgi-bin/text-idx?SID=c380a0544e78ca551398c0f7e64b699b&tpl=/ecfrbrowse/Title21/21tab_02.tpl to answer the following: CFR, Title 21, Part 11 1. What are the general requirements for electronic signatures? CFR, Title 21, Part 50 2. What is the definition of investigator? 3. What is the definition of minimal risk? 4. What section outlines the elements of informed consent? 5. In three sentences, discuss how you document an informed consent. 6. List three requirements for permission by parents or guardians and for assent by children. CFR, Title 21, Part 54 7. What is the definition of proprietary interest in the tested product? 8. What section in Part 54 references recordkeeping and record retention? CFR, Title 21, Part 56 9. What is the definition of IRB Approval? 10. List 3 functions of an IRB. 11. In one sentence, describe the suspension or termination of IRB approval of research. 12. List 2 requirements for IRB records. CFR, Title 21, Part 312 13. Name two ways the FDA can grant a waiver. 14. What section is the IND content and format outlined? 15. How soon should a sponsor submit follow-up information from an IND Safety Report? 16. List the 4 types of investigator reports. 17. What information must be submitted to the FDA, if sponsors choose to rely on foreign clinical studies to support an IND or to support an application for marketing approval? CFR, Title 21, Part 314 18. What is the definition of Postmarketing 15-day “Alert reports”? 19. In section 314.100, what is a review clock? 20. In section 314.126 summarize 4 of the 7 characteristics of an adequate and well-controlled study. |
