Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023
From GxPlex
| Document information | |
|---|---|
| Reference | USA Informed Consent -
FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 |
| Validity area | USA |
| Scope(s) | G |
| Document name | Informed Consent -
FDA Guidance for IRBs, Clinical Investigators, and Sponsors |
| Version / Revision | Aug-2023 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Informed Consent
Guidance for IRBs, Clinical Investigators, and Sponsors |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Introduction | G | II. Introduction | EN | II. SUMMARY OF THE CONSENT PROCESS To many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the consent form;9 however, obtaining documentation of ... |
| Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-001 | G | II. Advertising | EN | II. SUMMARY OF THE CONSENT PROCESS […] FDA considers advertising used to recruit subjects into the clinical trial to be the start of the ongoing consent process, and the information provided in any ... |
| Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 III. | G | III. | EN | III. FDA INFORMED CONSENT REQUIREMENTS AND DISCUSSION […] E. Documentation of Informed Consent [...] b. Short Form An IRB may approve a short form to be used in appropriate situations where the ... |
| Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV. | G | IV. | EN | IV. RESPONSIBILITIES FOR INFORMED CONSENT […] B. The Clinical Investigator The clinical investigator is responsible for protecting the rights, safety, and welfare of subjects during a clinical ... |
| Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V. | G | V. | EN | V. FREQUENTLY ASKED QUESTIONS […] 1. What are some considerations for enrolling a child into a clinical investigation? [...] 2. Are there any additional protections required when enrolling children ... |
| Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002 | G | II. Advertising | EN | II. SUMMARY OF THE CONSENT PROCESS […] FDA considers advertising used to recruit subjects into the clinical trial to be the start of the ongoing consent process, and the information provided in any ... |
