documents

Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

5 rows where docket_id = "FDA-2001-D-0219" and posted_year = 2010 sorted by posted_date descending

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posted_year 1

  • 2010 · 5 ✖

document_type 1

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2001-D-0219-0014 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Tab E - Tab E-Guidance for Industry, ICR E6, Good Clinica1 Practice: Consolidated Guidance, April 1996 [Guidance of 3/28/2006] Supporting & Related Material BKG-Background Material 2010-05-10T04:00:00Z 2010 5     2010-05-10T20:08:54Z   0 0 09000064804e4eb3
FDA-2001-D-0219-0013 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Tab D - Guidance for Industry, ICH E9, Statistical Principles forClinical Trials, September 1998 [Guidance of 3/28/2006] Supporting & Related Material BKG-Background Material 2010-05-10T04:00:00Z 2010 5     2010-05-10T20:08:52Z   0 0 09000064804e4eac
FDA-2001-D-0219-0010 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Clinical Trial Sponsors on the Establishment & Operation of Clinical Trial Monitoring Committees, November 2201 - Draft Guidance Supporting & Related Material GDL-Guidance 2010-05-10T04:00:00Z 2010 5     2010-05-10T18:54:00Z   0 0 09000064804e4dee
FDA-2001-D-0219-0011 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 List of References [Guidance for Clinical Trial SponsorsEstablishment & Operation of Clinical Trial Monitoring Committees 3/28/2006] Supporting & Related Material BKG-Background Material 2010-05-10T04:00:00Z 2010 5     2010-05-10T19:48:22Z   0 0 09000064804e4ea1
FDA-2001-D-0219-0012 FDA Establishment & Operation of Clinical Trial Monitoring Comm FDA-2001-D-0219 Tab C - DHHS, Finaneial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection May 5, 2004. [Guidance of 3/28/2006] Supporting & Related Material BKG-Background Material 2010-05-10T04:00:00Z 2010 5     2010-05-10T19:45:19Z   0 0 09000064804e4ea3

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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;