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withdrawn,object_id
FDA-2001-D-0219-0015,FDA,FDA-2001-D-0219,"Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry; Availability; Agency
Information Collection Activities; Proposed Collection; Comment Request",Notice,Notice of Availability,2024-02-13T05:00:00Z,2024,2,,,2024-02-13T14:42:27Z,2024-02849,0,0,0900006486404168
FDA-2001-D-0219-0016,FDA,FDA-2001-D-0219,Use of Data Monitoring Committees in Clinical Trials; Guidance for Industry; Draft Guidance,Other,Guidance,2024-02-13T05:00:00Z,2024,2,2024-02-13T05:00:00Z,2024-04-16T03:59:59Z,2025-06-06T09:00:07Z,,1,0,0900006486404548
FDA-2001-D-0219-0014,FDA,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,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,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Trial Sponsors on the Establishment & Operation of Clinical Trial Monitoring Committees, November 2201 - Draft Guidance",Supporting & Related Material,GDL-Guidance,2010-05-10T04:00:00Z,2010,5,,,2010-05-10T18:54:00Z,,0,0,09000064804e4dee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,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,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
FDA-2001-D-0219-0009,FDA,FDA-2001-D-0219,Agency Information Collection Activities; Announcement of Office  of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees,Notice,NAL-Notice of Approval,2006-07-31T04:00:00Z,2006,7,2006-07-28T04:00:00Z,,2010-05-10T16:54:40Z,,0,0,09000064804e4ed0
FDA-2001-D-0219-0007,FDA,FDA-2001-D-0219,Supporting Statement,Supporting & Related Material,SS-Supporting Statement,2006-07-31T04:00:00Z,2006,7,,,2008-04-25T02:28:20Z,,0,0,09000064804e4ecb
FDA-2001-D-0219-0008,FDA,FDA-2001-D-0219,Supporting Statement,Supporting & Related Material,SS-Supporting Statement,2006-07-31T04:00:00Z,2006,7,,,2008-04-25T02:28:19Z,,0,0,09000064804e4ece
FDA-2001-D-0219-0005,FDA,FDA-2001-D-0219,Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees; Availability,Notice,NAD-Notice of Availability of Data,2006-03-28T05:00:00Z,2006,3,2006-03-27T05:00:00Z,,2010-05-10T16:50:29Z,,0,0,09000064804e4ec0
FDA-2001-D-0219-0006,FDA,FDA-2001-D-0219,"Guidance for Clinical Trial Sponsors; Establishment and Operation of Clinical Trial Data Monitoring Committees, March 2006",Supporting & Related Material,GDL-Guidance,2006-03-28T05:00:00Z,2006,3,,,2010-05-10T20:21:50Z,,0,0,09000064804e4ec4
FDA-2001-D-0219-0003,FDA,FDA-2001-D-0219,Guidance for Clinical Trial Sponsors; Establishment and Operation of Clinical Trial Data Monitoring Committee December 2005 - Draft Guidance,Supporting & Related Material,GDL-Guidance,2006-01-10T05:00:00Z,2006,1,,,2010-05-10T18:57:16Z,,0,0,09000064804e4e9c
FDA-2001-D-0219-0004,FDA,FDA-2001-D-0219,Agency Information Collection Activities; Submission for Office,Notice,N-Notice,2006-01-10T05:00:00Z,2006,1,,,2010-05-10T16:43:43Z,,0,0,09000064804e4e9e
FDA-2001-D-0219-0002,FDA,FDA-2001-D-0219,Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees; Availability,Notice,NAD-Notice of Availability of Data,2001-11-20T05:00:00Z,2001,11,2001-11-19T05:00:00Z,2002-02-20T04:59:59Z,2010-05-10T16:34:55Z,,0,0,09000064804e4e02
FDA-2001-D-0219-0001,FDA,FDA-2001-D-0219,Draft FDA Guidance on the Estabtishment and Operation of Clinical Trial Data Monitoring Committees; Public Meeting,Notice,NM-Notice of Meeting,2001-11-05T05:00:00Z,2001,11,,,2010-05-10T16:33:19Z,,0,0,09000064804e4d7b