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28 rows where docket_id = "FDA-2009-N-0592" sorted by posted_date descending
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document_type 4
agency_id 1
- FDA 28
| id | agency_id | docket_id | title | document_type | subtype | posted_date ▲ | posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FDA-2009-N-0592-0091 | FDA | None FDA-2009-N-0592 | OMB Review, Executive Order 12866 (E.O.)[Informed Consent Elements, January 4, 2011 (76 FR 256) ] - Reference | Other | REF-Reference | 2011-02-17T05:00:00Z | 2011 | 2 | 2011-02-17T05:00:00Z | 2013-08-11T04:44:17Z | 0 | 0 | 0900006480bf16bc | ||
| FDA-2009-N-0592-0076 | FDA | None FDA-2009-N-0592 | Reference 9a - "Mayo Clinic Informed Consent, IRB Consent Form..." - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:17Z | 0 | 0 | 0900006480bc2082 | |||
| FDA-2009-N-0592-0084 | FDA | None FDA-2009-N-0592 | Reference 9i - "American College of Radiology Imaging Network (ACRIN), Protocol Development & Regulatory Resources, Sample Consent Research Study" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:13Z | 0 | 0 | 0900006480bc3de2 | |||
| FDA-2009-N-0592-0079 | FDA | None FDA-2009-N-0592 | Reference 9d - "University of Michigan Consent To Be Part of a Research Study" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:15Z | 0 | 0 | 0900006480bc208f | |||
| FDA-2009-N-0592-0081 | FDA | None FDA-2009-N-0592 | Reference 9f - "Children's Hospital Boston, Research Consent Form" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:15Z | 0 | 0 | 0900006480bc2095 | |||
| FDA-2009-N-0592-0077 | FDA | None FDA-2009-N-0592 | Reference 9b - "Stanford University Research Consent Form" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:17Z | 0 | 0 | 0900006480bc2083 | |||
| FDA-2009-N-0592-0078 | FDA | None FDA-2009-N-0592 | Reference 9c - "Duke University Health System Consent to Participate in a Research Study" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:10Z | 0 | 0 | 0900006480bc208e | |||
| FDA-2009-N-0592-0087 | FDA | None FDA-2009-N-0592 | Reference 13 - "FDA: A Guide to Informed Consent--Information Sheet" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:17Z | 0 | 0 | 0900006480bc3e0d | |||
| FDA-2009-N-0592-0074 | FDA | None FDA-2009-N-0592 | Reference 4 - "Trials of War Criminals, Nuernberg Military Tribunals, Nuernberg Code" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:13Z | 0 | 0 | 0900006480bc207b | |||
| FDA-2009-N-0592-0085 | FDA | None FDA-2009-N-0592 | Reference 9j - "National Cancer Institute Templates, Informed Consent Template for Cancer Treatment Trials, August 2009" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:16Z | 0 | 0 | 0900006480bc3de5 | |||
| FDA-2009-N-0592-0071 | FDA | None FDA-2009-N-0592 | Reference 1 - "Protection of Human Subjects;Informed Consent, Federal Register Volume 46 Number 17, Tuesday. January 27, 1981" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:12Z | 0 | 0 | 0900006480bc1ee7 | |||
| FDA-2009-N-0592-0072 | FDA | None FDA-2009-N-0592 | Reference 2 - "The Belmont Report..., April 18, 1979" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:12Z | 0 | 0 | 0900006480bc1ee9 | |||
| FDA-2009-N-0592-0080 | FDA | None FDA-2009-N-0592 | Reference 9e - "Informed Consent to Participate in Research, University of Texas at Austin" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:16Z | 0 | 0 | 0900006480bc2094 | |||
| FDA-2009-N-0592-0089 | FDA | None FDA-2009-N-0592 | Reference 15 - "Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable, April 25, 2006" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:11Z | 0 | 0 | 0900006480bc3e0f | |||
| FDA-2009-N-0592-0090 | FDA | None FDA-2009-N-0592 | Reference 16 - "NIH: ClinicalTrials.gov “Basic Results Data Element Definitions (DRAFT), February 2010" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:14Z | 0 | 0 | 0900006480bc3e10 | |||
| FDA-2009-N-0592-0075 | FDA | None FDA-2009-N-0592 | Reference 6 - "World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:14Z | 0 | 0 | 0900006480bc207f | |||
| FDA-2009-N-0592-0070 | FDA | None FDA-2009-N-0592 | Reference List, (References 1-16) - [Informed Consent Elements; Final Rule] re FDA-2009-N-0592-0069 | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:11Z | 0 | 0 | 0900006480bc480b | |||
| FDA-2009-N-0592-0073 | FDA | None FDA-2009-N-0592 | Reference 3 - "National Research Act PL93-348" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:15Z | 0 | 0 | 0900006480bc207a | |||
| FDA-2009-N-0592-0086 | FDA | None FDA-2009-N-0592 | Reference 12 - "FDA, Office of Planning, Risk Communication Staff, Analysis Note, July 30, 2010, Informal Testing of Clinical Trials Informed Consent Statement" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:12Z | 0 | 0 | 0900006480bc3e0c | |||
| FDA-2009-N-0592-0088 | FDA | None FDA-2009-N-0592 | Reference 14 - "NIH-PRS Information: U.S. Public Law 110-85" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:11Z | 0 | 0 | 0900006480bc3e0e | |||
| FDA-2009-N-0592-0083 | FDA | None FDA-2009-N-0592 | Reference 9h - "Walter Reed Army Medical Center, NCA Templates "Informed Consent Form" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:13Z | 0 | 0 | 0900006480bc2f0e | |||
| FDA-2009-N-0592-0069 | FDA | None FDA-2009-N-0592 | Informed Consent Elements | Rule | NFR-Notice of Final Rule | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-01-04T05:00:00Z | 2011-06-11T16:28:13Z | 2010-33193 | 0 | 0 | 0900006480bc4ae4 | |
| FDA-2009-N-0592-0082 | FDA | None FDA-2009-N-0592 | Reference 9g - "Partners HealthCare System Research Consent Form, February 2010" - [Informed Consent Elements; Final Rule] | Supporting & Related Material | BKG-Background Material | 2011-01-04T05:00:00Z | 2011 | 1 | 2011-06-11T16:28:16Z | 0 | 0 | 0900006480bc2096 | |||
| FDA-2009-N-0592-0004 | FDA | None FDA-2009-N-0592 | Reference 3 - ‘‘National Research Act, Title II (Public Law 93–348, July 12, 1974)" - [Informed Consent Elements] | Supporting & Related Material | BKG-Background Material | 2009-12-30T05:00:00Z | 2009 | 12 | 2010-03-04T04:00:30Z | 0 | 0 | 0900006480a733d4 | |||
| FDA-2009-N-0592-0002 | FDA | None FDA-2009-N-0592 | Reference 1 - ‘‘Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10, Vol. 2, pp. 181–182. Office, 1949" - [Informed Consent Elements] | Supporting & Related Material | BKG-Background Material | 2009-12-30T05:00:00Z | 2009 | 12 | 2010-03-04T03:57:45Z | 0 | 0 | 0900006480a7336d | |||
| FDA-2009-N-0592-0003 | FDA | None FDA-2009-N-0592 | Reference 2 - "World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects" - [Informed Consent Elements] | Supporting & Related Material | BKG-Background Material | 2009-12-30T05:00:00Z | 2009 | 12 | 2010-03-04T03:59:28Z | 0 | 0 | 0900006480a733cd | |||
| FDA-2009-N-0592-0005 | FDA | None FDA-2009-N-0592 | Reference 4 - ‘‘National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, ‘‘The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research’’ - [Informed Consent Elements] | Supporting & Related Material | BKG-Background Material | 2009-12-30T05:00:00Z | 2009 | 12 | 2010-03-04T04:01:40Z | 0 | 0 | 0900006480a7340b | |||
| FDA-2009-N-0592-0001 | FDA | None FDA-2009-N-0592 | Informed Consent Elements | Proposed Rule | NPR-Notice of Proposed Rule-Making | 2009-12-29T05:00:00Z | 2009 | 12 | 2009-12-29T05:00:00Z | 2010-03-02T04:59:59Z | 2011-06-11T16:28:10Z | E9-30751 | 0 | 0 | 0900006480a7316e |
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CREATE TABLE documents (
id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;