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MTN-003 SSP Manual

DescriptionDateSize
I. Study-Specific Procedures Manual (SSP) Sections VERSION 2
Overview and Version Control [1]2012-Jan-26197.49 KB
Table of Contents [2]2011-May-02103.54 KB
Section 01: Introduction [3]2011-Feb-1885.17 KB
Section 02: Protocol [4]2011-Feb-181.05 MB
Section 03: Documentation Requirements [5]2011-Jun-10297.36 KB
Section 04: Participant Accrual [6]2011-Feb-18267.72 KB
Section 05: Informed Consent [7]2011-Feb-18317.23 KB
Section 06: Participant Follow-up [8]2011-Dec-20916.67 KB
Section 07: Visit Checklists [9]2011-Feb-18551.82 KB
Section 08: Participant Retention [10]2011-Feb-1850.21 KB
Section 09: Study Product Considerations for Non-Pharmacy Staff [11]2011-May-02192.59 KB
Section 10: Clinical Considerations [12]2011-Jun-10489.23 KB
Section 11: Adverse Event Reporting and Safety Monitoring [13]2011-Feb-18759.88 KB
Section 12: Counseling Considerations [14]2011-Sep-22761.02 KB
Section 13: Laboratory Considerations [15]2011-Sep-22992.49 KB
Section 14: Data Collection [16]2011-Feb-181.54 MB
Section 15: Data Communiques [17]2011-Feb-1810.28 KB
Section 16: ACASI Users Manual [18]2011-Feb-181.35 MB
Section 17: Study Reporting Plan [19]2011-Feb-1841.38 KB
Section 18: Bone Mineral Density Substudy (VOICE-B) [20]2012-Jan-19242.83 KB
Section 19: Household and Community Factors Associated with VOICE Product Adherence Substudy (VOICE-C) [21]2012-Jan-26357.29 KB
II. Study-Specific Procedures Manual (SSP) Sections VERSION 1
Overview and Version Control [22]2011-Jan-1846.9 KB
Table of Contents [23]2010-Apr-1697.38 KB
Section 01: Introduction [24]2009-Aug-0784.26 KB
Section 02: Protocol [25]2010-Apr-161.17 MB
Section 03: Documentation Requirements [26]2009-Aug-07156.49 KB
Section 04: Participant Accrual [27]2010-Nov-24202.9 KB
Section 05: Informed Consent [28]2010-Apr-16282.8 KB
Section 06: Participant Follow-up [29]2010-Nov-24329.72 KB
Section 07: Visit Checklists [30]2010-Apr-161.2 MB
Section 08: Participant Retention [31]2009-Aug-07109.35 KB
Section 09: Study Product Considerations for Non-Pharmacy Staff [32]2010-Apr-16270.62 KB
Section 10: Clinical Considerations [33]2010-Nov-24503.73 KB
Section 11: Adverse Event Reporting and Safety Monitoring [34]2010-Apr-16213 KB
Section 12: Counseling Considerations [35]2009-Aug-07434.32 KB
Section 13: Laboratory Considerations [36]2010-Nov-24306.39 KB
Section 14: Data Collection [37]2009-Aug-071.58 MB
Section 15: Data Communiques [38]2009-Aug-0714.24 KB
Section 15: Data Communiques #1 [39]2009-Sep-0951.22 KB
Section 15: Data Communiques #2 [40]2009-Dec-1636.78 KB
Section 15: Data Communiques #3 [41]2010-Apr-16331.94 KB
Section 16: ACASI Users Manual [42]2010-Nov-241.14 MB
Section 17: Study Reporting Plan [43]2009-Aug-0744.69 KB
Section 18: Bone Mineral Density Substudy (VOICE-B) [44]2012-Jan-19242.83 KB
Section 19: Household and Community Factors Associated with VOICE Product Adherence Substudy (VOICE-C) [45]2012-Jan-26357.29 KB
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Source URL: http://www.mtnstopshiv.org/node/1077

Links:
[1] http://www.mtnstopshiv.org/sites/default/files/attachments/MTN-003 SSP Overview and Version Control_26JAN12.pdf
[2] http://www.mtnstopshiv.org/sites/default/files/attachments/MTN-003 TOC_2MAY2011.pdf
[3] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_1_Introduction_V.2.0_18FEB2011.pdf
[4] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_2_Protocol_V.2.0_18FEB2011.pdf
[5] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 3_v2.1_Documentation Req_10June2011.pdf
[6] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 4_ 2.0_2011-02-18_Participant Accrual.pdf
[7] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_5_1nformed_Consent_V.2.0_18FEB2011.pdf
[8] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_6_V2 5_Follow Up_20DEC11.pdf
[9] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_7_Visit Checklist_V.2.0_18FEB2011.pdf
[10] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE__SSP_8_Participant_Retention_V.2.0_18FEB2011.pdf
[11] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 9 Version 2.0_2MAY2011_clean.pdf
[12] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_10_Clinical ConsiderationsV2.3.pdf
[13] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_11_AE_Reporting_V.2.0_18FEB2011.pdf
[14] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_12_Counseling Considerations_V2 2_22SEP2011.pdf
[15] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_13_V2 2_22Sep11_Laboratory Considerations.pdf
[16] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_14_Data_Collection_V.2_0_18FEB11.pdf
[17] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_15_Data_Communiques_V.2_0_18FEB11.pdf
[18] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_16_ACASI_V.2.0_18FEB2011.pdf
[19] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_17_Reporting_Plan_V.2_0_18FEB11.pdf
[20] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 18 Final 2 0 _003B_19Jan2012rev_0.pdf
[21] http://www.mtnstopshiv.org/sites/default/files/attachments/V-C SSP_v1.4_26Jan12_0.pdf
[22] http://www.mtnstopshiv.org/sites/default/files/attachments/MTN-003 SSP Overview and Version Control 2010 Revised_18JAN2011.pdf
[23] http://www.mtnstopshiv.org/sites/default/files/attachments/MTN_003_TOC_16Apr10.pdf
[24] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 1 Final 1.0 2009-08-07.pdf
[25] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_2_FINAL_v1.2_16April10.pdf
[26] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 3 Final 1.0 2009-08-07_0.pdf
[27] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 4 FINAL v1.3 24NOV10.pdf
[28] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_5_FINAL_v1.1_16Apr10.pdf
[29] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 6_23NOV10_0.pdf
[30] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_7_FINAL_v1.1_16April10.pdf
[31] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 8 Final 1.0 2009-08-07.pdf
[32] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_9_FINAL_v1.2_16April10.pdf
[33] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE10Combined.pdf
[34] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 11 FINAL v1.3 16April10_2.pdf
[35] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 12 Final 1.0 2009-08-07.pdf
[36] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE_SSP_13_24NOV10.pdf
[37] http://www.mtnstopshiv.org/sites/default/files/attachments/Section_14_Data_Collection_v1 0_FINAL04Sep09_rev.pdf
[38] http://www.mtnstopshiv.org/sites/default/files/attachments/Section 15_Data_Communiques_v1.0_FINAL07AUG09.pdf
[39] http://www.mtnstopshiv.org/sites/default/files/attachments/MTN003_Data Communique1-09SEP09.pdf
[40] http://www.mtnstopshiv.org/sites/default/files/attachments/MTN003_Data Communique2-16DEC09_0.pdf
[41] http://www.mtnstopshiv.org/sites/default/files/attachments/MTN003_Data Communique3-16APR10.pdf
[42] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 16 FINAL v1.4 24 Nov10.pdf
[43] http://www.mtnstopshiv.org/sites/default/files/attachments/Section_17_Reporting_Plan_FINAL07AUG09.pdf
[44] http://www.mtnstopshiv.org/sites/default/files/attachments/VOICE SSP 18 Final 2 0 _003B_19Jan2012rev_1.pdf
[45] http://www.mtnstopshiv.org/sites/default/files/attachments/V-C SSP_v1.4_26Jan12_1.pdf
[46] http://www.mtnstopshiv.org/print/1077

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