Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002
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 | |
| Reference Details | |
|---|---|
| Module | Module 3 â Unit 3.2.1 |
| Scope | G |
| Document part | II. Advertising |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Consent process, Enrolment, Informed consent, FDA |
Content
II. SUMMARY OF THE CONSENT PROCESS [âŚ] 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 online or hard copy recruitment materials should be consistent with the informed consent document. Generally, FDA recommends that any advertisement to recruit subjects be limited to the information the prospective subjects need to determine their interest and potential eligibility. The FDA information sheet âRecruiting Study Subjectsâ includes information regarding scripts for those who will interface with subjects to determine basic eligibility.13 [...]
