Overview of ICH GCP E6 by Olga Kishchenko https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby en-us 2023-02-07 12:36:44 UTC 2023-08-31 19:50:28 UTC hello@padlet.com The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680260163 2023-08-31 19:37:59 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680260163 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680260918 2023-08-31 19:38:55 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680260918 https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680261666 Standardized guidelines for all aspects of the trial

]]> 2023-08-31 19:39:47 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680261666 https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680261992 Informed consent form (ICF) and the clinical protocol]]> 2023-08-31 19:40:13 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680261992 IRB/IEC Composition https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680262876 2023-08-31 19:41:18 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680262876 https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680263366 Learned the term Comparator--aka Placebo]]> 2023-08-31 19:41:50 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680263366 Investigator's brochure https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680263421 2023-08-31 19:41:54 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680263421 Principal investigator, sponsor and IRB https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680263439 2023-08-31 19:41:55 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680263439 https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680264804 Have heard this term thrown around before now I know what it is!

Investigator's Brochure

A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects 
]]> 2023-08-31 19:43:35 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680264804 Consent must be documented before the clinical phase of the trial. https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680265042 2023-08-31 19:43:52 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680265042 A glossary or Terms. :) Very much needed... https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680265811 2023-08-31 19:44:47 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680265811 The purpose of the Insurance Statement is to document compensation to subjects for trial-related injury. https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680266239 2023-08-31 19:45:15 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680266239 https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680268156 GCP - These standardized guidelines are also recognized internationally]]> 2023-08-31 19:47:40 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680268156 Essential documents are crucial to ensuring clinical trials are conducted within compliance in accordance with GCP guidelines https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680269053 2023-08-31 19:48:42 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680269053 https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680269141 As someone new to this field, the glossary is super helpful with all the acronyms ]]> 2023-08-31 19:48:48 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680269141 https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680269155 Documents needed to conduct a clinical trial]]> 2023-08-31 19:48:50 UTC https://padlet.com/kishchenkoolga/co6ylu4jvpc5jwby/wish/2680269155