WebThe Investigation Plan Template 1. What is being investigated? 2. What is the overall approach to gathering the evidence? 3. What and where is the evidence? 4. What problems might arise during the investigation? 5. What resources will be required? 6. How are internal and external communications going to be managed? 7. What are the milestones ... Webprogramme is provided in Appendix 2. Earlier preclinical investigations demonstrated that ZB3579 blocks hERG-encoded potassium channels with an IC50 value of 0.09 μM, …

What You Need To Know - U.S. Food and Drug Administration

Web4 General Investigational Plan [21 CFR 312.23(a)(4)] 4.1 Research Rationale and Objectives Discuss the research rationale for the use of the study agent and the specific … WebInvestigational New Drug (IND) Terms in this set (59) 21 CFR 312.1 This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's). Commercial le salaire minimum en haiti

[ICH E2F] [EXAMPLE DSUR – PHASE III INVESTIGATIONAL …

WebNote: If an investigation involves an exception from informed consent for emergency research, state on the Cover Sheet. 3. Table of Contents Provide a detailed Table of … WebFor a Sponsor-Investigator IND, you may simply state you are not aware of any withdrawals. References. List any references for Section 2. General Investigational Plan. Rationale. State here the rationale for the research study planned. Briefly refer to the non-clinical data supporting the rationale if relevant. Webproposed clinical investigation or to suspend an ongoing investigation Once active, an IND may be placed on hold if the grounds listed under 21 CFR 312.42(b) are met Partial Hold: A delay or suspension of part of the clinical work under an IND e.g. IND has 2 protocols, one may proceed & one may not le salem haillan