Title 42

PART 11

Part 11 - Clinical Trials Registration And Results Information Submission

PART 11 - CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION Authority:42 U.S.C. 282(i); 42 U.S.C. 282(j); 5 U.S.C. 301; 42 U.S.C. 286(a); 42 U.S.C. 241(a); 42 U.S.C. 216(b). Source:81 FR 65138, Sept. 21, 2016, unless otherwise noted.

• Authority: 42 U.S.C. 282(i); 42 U.S.C. 282(j); 5 U.S.C. 301; 42 U.S.C. 286(a); 42 U.S.C. 241(a); 42 U.S.C. 216(b).
• Source: 81 FR 65138, Sept. 21, 2016, unless otherwise noted.

42:1.0.1.1.12.1	SUBPART A	Subpart A - General Provisions
42:1.0.1.1.12.1.1.1	SECTION 11.2	11.2 What is the purpose of this part
42:1.0.1.1.12.1.1.2	SECTION 11.4	11.4 To whom does this part apply
42:1.0.1.1.12.1.1.3	SECTION 11.6	11.6 What are the requirements for the submission of truthful information
42:1.0.1.1.12.1.1.4	SECTION 11.8	11.8 In what format must clinical trial information be submitted
42:1.0.1.1.12.1.1.5	SECTION 11.10	11.10 What definitions apply to this part
42:1.0.1.1.12.2	SUBPART B	Subpart B - Registration
42:1.0.1.1.12.2.1.1	SECTION 11.20	11.20 Who must submit clinical trial registration information
42:1.0.1.1.12.2.1.2	SECTION 11.22	11.22 Which applicable clinical trials must be registered
42:1.0.1.1.12.2.1.3	SECTION 11.24	11.24 When must clinical trial registration information be submitted
42:1.0.1.1.12.2.1.4	SECTION 11.28	11.28 What constitutes clinical trial registration information
42:1.0.1.1.12.2.1.5	SECTION 11.35	11.35 By when will the NIH Director post clinical trial registration information submitted under § 11.28
42:1.0.1.1.12.3	SUBPART C	Subpart C - Results Information Submission
42:1.0.1.1.12.3.1.1	SECTION 11.40	11.40 Who must submit clinical trial results information
42:1.0.1.1.12.3.1.2	SECTION 11.42	11.42 For which applicable clinical trials must clinical trial results information be submitted
42:1.0.1.1.12.3.1.3	SECTION 11.44	11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42
42:1.0.1.1.12.3.1.4	SECTION 11.48	11.48 What constitutes clinical trial results information
42:1.0.1.1.12.3.1.5	SECTION 11.52	11.52 By when will the NIH Director post submitted clinical trial results information
42:1.0.1.1.12.3.1.6	SECTION 11.54	11.54 What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission
42:1.0.1.1.12.4	SUBPART D	Subpart D - Additional Submission of Clinical Trial Information
42:1.0.1.1.12.4.1.1	SECTION 11.60	11.60 What requirements apply to the voluntary submission of clinical trial information for clinical trials of FDA-regulated drug products (including biological products) and device products
42:1.0.1.1.12.4.1.2	SECTION 11.62	11.62 What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health
42:1.0.1.1.12.4.1.3	SECTION 11.64	11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected
42:1.0.1.1.12.5	SUBPART E	Subpart E - Potential Legal Consequences of Non-Compliance
42:1.0.1.1.12.5.1.1	SECTION 11.66	11.66 What are potential legal consequences of not complying with the requirements of this part

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