Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.10 (b) (5)
From GxPlex
| Document information | |
|---|---|
| Reference | USA 42 CFR Part 11 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 42 CFR Part 11 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 42—Public Health
Chapter I—Public Health Service, Department of Health and Human Services Subchapter A—General Provisions Part 11 Clinical Trials Registration and Results Information Submission https://www.ecfr.gov/current/title-42 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.3.2 |
| Scope | G |
| Document part | § 11.10
(b) (5) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Study design, Definition, Randomisation, Blinding, ClinicalTrials.gov |
Content
(5) Study Design means a description of the manner in which the clinical trial will be conducted, including the following information:
(i) Interventional Study Model. The strategy for assigning interventions to human subjects. (ii) Number of Arms. The number of arms in the clinical trial. For a trial with multiple periods or phases that have different numbers of arms, it means the maximum number of arms during all periods or phases. (iii) Arm Information. A description of each arm of the clinical trial that indicates its role in the clinical trial, provides an informative title, and, if necessary, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. (iv) Allocation. The method by which human subjects are assigned to arms in a clinical trial. (v) Masking. The party or parties, if any, involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual human subjects.
