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MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034. MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). The primary objectives of MTN-034 are to collectsafety and
MTN-043 STUDY IMPLEMENTATION MATERIALS Lab/Sample Collection; AVERY L7656 Labels or Equivalent (for A4 paper) 2020-01-28: 282.5 KB: MTN Laboratory Center HIV Testing Notification & Query Form : 2016-04-13 MTN-039 | MICROBICIDE TRIALS NETWORK MTN-039. MTN-039 was ad Phase 1, open-label, multi-site single arm, two-period study designed to evaluate the safety and pharmacokinetics (PK) of Tenofovir Alafenamide (TAF) and elvitegravir (EVG) administered rectally as an insert at two dose levels. Elvitegravir is SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356TONGAAT CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 STANDARD OPERATING PROCEDURE: SOURCE DOCUMENTATION Source Documentation SOP Addenda Requirement • If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional entry or addendum to the source documentation. The later entry must be signed/initialed anddated.
POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034. MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). The primary objectives of MTN-034 are to collectsafety and
MTN-043 STUDY IMPLEMENTATION MATERIALS Lab/Sample Collection; AVERY L7656 Labels or Equivalent (for A4 paper) 2020-01-28: 282.5 KB: MTN Laboratory Center HIV Testing Notification & Query Form : 2016-04-13 MTN-039 | MICROBICIDE TRIALS NETWORK MTN-039. MTN-039 was ad Phase 1, open-label, multi-site single arm, two-period study designed to evaluate the safety and pharmacokinetics (PK) of Tenofovir Alafenamide (TAF) and elvitegravir (EVG) administered rectally as an insert at two dose levels. Elvitegravir is SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356TONGAAT CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 STANDARD OPERATING PROCEDURE: SOURCE DOCUMENTATION Source Documentation SOP Addenda Requirement • If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional entry or addendum to the source documentation. The later entry must be signed/initialed anddated.
POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the RESEARCH | MICROBICIDE TRIALS NETWORK MTN studies are designed specifically to support the potential licensure and regulatory approval of promising microbicides applied inside the vagina or rectum to prevent the sexual transmission of HIV. MTN-043 | MICROBICIDE TRIALS NETWORK MTN-043 is a Phase 3B, open-label, randomized (3:1), multi-site, mother-infant pair PK study designed to assess the safety, PK, adherence, and acceptability of the 25 mg dapivirine VR inserted every 4-weeks and the once-daily Truvada (200 mg FTC/300 mg TDF) tablet used by women from sub-Saharan countries during breastfeeding. MTN-025 | MICROBICIDE TRIALS NETWORK MTN-025. MTN-025, the HIV Open-label Prevention Extension (HOPE) trial, was a multi-site, open-label, Phase 3B trial. Eligible HIV-uninfected former ASPIRE participants were offered a silicone elastomer VR containing 25 mg of dapivirine. Participants could choose not to accept study product at any time and still take part in thestudy.
SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.MTN-023/IPM 030
MTN-023/IPM 030 was a multi-center, two-arm, randomized, double-blind, placebo-controlled Phase 2a trial. The study enrolled 96 healthy, HIV-uninfected adolescent females, 15 - 17 years old (inclusive). Participants were randomized in a 3:1 ratio to one of the following study groups: dapivirine (25 mg) VR or KAMWALA HEALTH CENTRE CRS Microbicide Trials Network. All Rights Reserved. SECTION 11. DATA COLLECTION MTN-043 SSP Manual Version 1.1, Protocol Version 1.0 29 January 2021 Section 11 Page 11-2 of 11-19 11.1 Medidata Rave Overview Medidata Rave is the data management system used by SCHARP to receive andmanage study data
STANDARD OPERATING PROCEDURE: SOURCE DOCUMENTATION Source Documentation SOP Addenda Requirement • If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional entry or addendum to the source documentation. The later entry must be signed/initialed anddated.
LABORATORY ERRORS: FINDING THE ROOT CAUSE Ask “Why” 5 Times • Write down the specific problem • Ask why the problem happened • Write down the answer • If the answer doesn’t identify the root cause of the HEMATOLOGY, CHEMISTRY, COAGULATION Hematology • The laboratory must verify calibration on the instrument every 6 months or on an “as needed” basis to ensure accuracy of the system. HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034. MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). The primary objectives of MTN-034 are to collectsafety and
MTN-043 | MICROBICIDE TRIALS NETWORK MTN-043. MTN-043 is a Phase 3B, open-label, randomized (3:1), multi-site, mother-infant pair PK study designed to assess the safety, PK, adherence, and acceptability of the 25 mg dapivirine VR inserted every 4-weeks and the once-daily Truvada (200 mg FTC/300 mg TDF) tablet used by women from sub-Saharan countries during breastfeeding.CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 KAMWALA HEALTH CENTRE CRS Microbicide Trials Network. All Rights Reserved. SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks. SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. LABORATORY ERRORS: FINDING THE ROOT CAUSE Ask “Why” 5 Times • Write down the specific problem • Ask why the problem happened • Write down the answer • If the answer doesn’t identify the root cause of the POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034. MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). The primary objectives of MTN-034 are to collectsafety and
MTN-043 | MICROBICIDE TRIALS NETWORK MTN-043. MTN-043 is a Phase 3B, open-label, randomized (3:1), multi-site, mother-infant pair PK study designed to assess the safety, PK, adherence, and acceptability of the 25 mg dapivirine VR inserted every 4-weeks and the once-daily Truvada (200 mg FTC/300 mg TDF) tablet used by women from sub-Saharan countries during breastfeeding.CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 KAMWALA HEALTH CENTRE CRS Microbicide Trials Network. All Rights Reserved. SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks. SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. LABORATORY ERRORS: FINDING THE ROOT CAUSE Ask “Why” 5 Times • Write down the specific problem • Ask why the problem happened • Write down the answer • If the answer doesn’t identify the root cause of the POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the MANUAL OF OPERATIONAL PROCEDURES Section 01: Network Overview and Structure (Download) 2019-05-31. 301.47 KB. Section 02: Network Executive Committee (Download) 2019-05-31. 93.03 KB. Section 03: Network Operational Components (Download) 2019-05-31. 342.53 KB. MTN-043 STUDY IMPLEMENTATION MATERIALS Lab/Sample Collection; AVERY L7656 Labels or Equivalent (for A4 paper) 2020-01-28: 282.5 KB: MTN Laboratory Center HIV Testing Notification & Query Form : 2016-04-13 MTN-037 | MICROBICIDE TRIALS NETWORK MTN-037. MTN-037 is a Phase 1, open label, sequential dose/volume escalation study designed to evaluate the safety and pharmacokinetics of PC-1005 (MIV-150/zinc acetate/carrageenan gel) when administered rectally. Approximately 12 healthy, HIV-uninfected men and women (cis or transgender) who are 18 years of age or older and who have ahistory
SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks. AGES & STAGES QUESTIONNAIRES 4 MONTH QUESTIONNAIRE Ages & Stages Questionnaires ®, Third Edition (ASQ -3) eserved. page 2 of 5 E101040200 4Month Questionnaire 3 months 0 days through 4 months 30 days Important Points to Remember: Try each activity with your baby before marking a response. Make completing this questionnaire a game that is fun for you and your baby. Make sure your baby is rested and fed.MTN-023/IPM 030
MTN-023/IPM 030 was a multi-center, two-arm, randomized, double-blind, placebo-controlled Phase 2a trial. The study enrolled 96 healthy, HIV-uninfected adolescent females, 15 - 17 years old (inclusive). Participants were randomized in a 3:1 ratio to one of the following study groups: dapivirine (25 mg) VR or SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. MTNSTOPSHIV.ORGWEB VIEW Author: Hawley, Imogen Last modified by: Katz, Ariana Created Date: 1/9/2020 11:07:13 PM Other titles: Instructions IDI QPL SCIDI QPL POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the REQUIREMENTS FOR SOURCE DOCUMENTATION IN DAIDS FUNDED AND POLICY No.: DWD-POL-CL-04.00 Requirements for Source Documentation in DAIDS Funded and/or Sponsored Clinical Trials Page 1 of 4 DAIDS Bethesda, MD USA Approval Date: 20 DEC 06 HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS “A Look Back ” is an occasional series to honor the communities, researchers, staff and study participants who have made countless and meaningful contributions to the work of the MTN since 2006. MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
MTN-043 | MICROBICIDE TRIALS NETWORK MTN-043 is a Phase 3B, open-label, randomized (3:1), multi-site, mother-infant pair PK study designed to assess the safety, PK, adherence, and acceptability of the 25 mg dapivirine VR inserted every 4-weeks and the once-daily Truvada (200 mg FTC/300 mg TDF) tablet used by women from sub-Saharan countries during breastfeeding. MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive).CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 KAMWALA HEALTH CENTRE CRS Microbicide Trials Network. All Rights Reserved. SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks. SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. LABORATORY ERRORS: FINDING THE ROOT CAUSE Ask “Why” 5 Times • Write down the specific problem • Ask why the problem happened • Write down the answer • If the answer doesn’t identify the root cause of the POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS “A Look Back ” is an occasional series to honor the communities, researchers, staff and study participants who have made countless and meaningful contributions to the work of the MTN since 2006. MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
MTN-043 | MICROBICIDE TRIALS NETWORK MTN-043 is a Phase 3B, open-label, randomized (3:1), multi-site, mother-infant pair PK study designed to assess the safety, PK, adherence, and acceptability of the 25 mg dapivirine VR inserted every 4-weeks and the once-daily Truvada (200 mg FTC/300 mg TDF) tablet used by women from sub-Saharan countries during breastfeeding. MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive).CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 KAMWALA HEALTH CENTRE CRS Microbicide Trials Network. All Rights Reserved. SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks. SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. LABORATORY ERRORS: FINDING THE ROOT CAUSE Ask “Why” 5 Times • Write down the specific problem • Ask why the problem happened • Write down the answer • If the answer doesn’t identify the root cause of the POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the MANUAL OF OPERATIONAL PROCEDURES 2019 MTN MOP - Individual Sections; Notice of Change - READ ME FIRST : 2019-05-31: 188.33 KB: Table of Contents : 2019-05-31: 1.1 MB: Section 01: Network Overview and Structure : MTN-043 STUDY IMPLEMENTATION MATERIALS Lab/Sample Collection; AVERY L7656 Labels or Equivalent (for A4 paper) 2020-01-28: 282.5 KB: MTN Laboratory Center HIV Testing Notification & Query Form : 2016-04-13 MTN-037 | MICROBICIDE TRIALS NETWORK MTN-037 was a Phase 1, open-label, sequential dose/volume escalation study designed to evaluate the safety and pharmacokinetics of PC-1005(MIV-150/zinc
MTN-023/IPM 030
MTN-023/IPM 030 was a multi-center, two-arm, randomized, double-blind, placebo-controlled Phase 2a trial. The study enrolled 96 healthy, HIV-uninfected adolescent females, 15 - 17 years old (inclusive). SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks. AGES & STAGES QUESTIONNAIRES 4 MONTH QUESTIONNAIRE Ages & Stages Questionnaires ®, Third Edition (ASQ -3) eserved. page 2 of 5 E101040200 4Month Questionnaire 3 months 0 days through 4 months 30 days Important Points to Remember: Try each activity with your baby before marking a response. Make completing this questionnaire a game that is fun for you and your baby. Make sure your baby is rested and fed. SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. MTNSTOPSHIV.ORGWEB VIEW Author: Hawley, Imogen Last modified by: Katz, Ariana Created Date: 1/9/2020 11:07:13 PM Other titles: Instructions IDI QPL SCIDI QPL POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the REQUIREMENTS FOR SOURCE DOCUMENTATION IN DAIDS FUNDED AND POLICY No.: DWD-POL-CL-04.00 Requirements for Source Documentation in DAIDS Funded and/or Sponsored Clinical Trials Page 1 of 4 DAIDS Bethesda, MD USA Approval Date: 20 DEC 06 HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
RESEARCH | MICROBICIDE TRIALS NETWORK MTN studies are designed specifically to support the potential licensure and regulatory approval of promising microbicides applied inside the vagina or rectum to prevent the sexual transmission of HIV. MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
SECTION 8. ADVERSE EVENT REPORTING AND SAFETY MONITORING MTN-034 SSP Manual Version 1.4, Protocol Version 2.0 05JAN2021 Section 8 Page 8-3 of 8-23 • Is a congenital anomaly/birth defect SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 SECTION 11. DATA COLLECTION MTN-043 SSP Manual Version 1.1, Protocol Version 1.0 29 January 2021 Section 11 Page 11-2 of 11-19 11.1 Medidata Rave Overview Medidata Rave is the data management system used by SCHARP to receive andmanage study data
STANDARD OPERATING PROCEDURE: SOURCE DOCUMENTATION Source Documentation SOP Addenda Requirement • If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional entry or addendum to the source documentation. The later entry must be signed/initialed anddated.
SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. HEMATOLOGY, CHEMISTRY, COAGULATION Hematology • The laboratory must verify calibration on the instrument every 6 months or on an “as needed” basis to ensure accuracy of the system. HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
RESEARCH | MICROBICIDE TRIALS NETWORK MTN studies are designed specifically to support the potential licensure and regulatory approval of promising microbicides applied inside the vagina or rectum to prevent the sexual transmission of HIV. MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
SECTION 8. ADVERSE EVENT REPORTING AND SAFETY MONITORING MTN-034 SSP Manual Version 1.4, Protocol Version 2.0 05JAN2021 Section 8 Page 8-3 of 8-23 • Is a congenital anomaly/birth defect SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 SECTION 11. DATA COLLECTION MTN-043 SSP Manual Version 1.1, Protocol Version 1.0 29 January 2021 Section 11 Page 11-2 of 11-19 11.1 Medidata Rave Overview Medidata Rave is the data management system used by SCHARP to receive andmanage study data
STANDARD OPERATING PROCEDURE: SOURCE DOCUMENTATION Source Documentation SOP Addenda Requirement • If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional entry or addendum to the source documentation. The later entry must be signed/initialed anddated.
SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. HEMATOLOGY, CHEMISTRY, COAGULATION Hematology • The laboratory must verify calibration on the instrument every 6 months or on an “as needed” basis to ensure accuracy of the system. STUDIES | MICROBICIDE TRIALS NETWORK A phase 1 clinical trial to evaluate the safety and immunogenicity of DNA/NYVAC prime boost vaccination with or without oral emtricitabine/tenofovir or vaginal tenofovir 1% gel in healthy, HIV-1–uninfected adult female participants. Phase 2 Adherence and Pharmacokinetics Study MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034. MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). The primary objectives of MTN-034 are to collectsafety and
MTN-043 STUDY IMPLEMENTATION MATERIALS Lab/Sample Collection; AVERY L7656 Labels or Equivalent (for A4 paper) 2020-01-28: 282.5 KB: MTN Laboratory Center HIV Testing Notification & Query Form : 2016-04-13 MANUAL OF OPERATIONAL PROCEDURES Section 01: Network Overview and Structure (Download) 2019-05-31. 301.47 KB. Section 02: Network Executive Committee (Download) 2019-05-31. 93.03 KB. Section 03: Network Operational Components (Download) 2019-05-31. 342.53 KB. SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.MTN-023/IPM 030
MTN-023/IPM 030 was a multi-center, two-arm, randomized, double-blind, placebo-controlled Phase 2a trial. The study enrolled 96 healthy, HIV-uninfected adolescent females, 15 - 17 years old (inclusive). Participants were randomized in a 3:1 ratio to one of the following study groups: dapivirine (25 mg) VR or KAMWALA HEALTH CENTRE CRS Microbicide Trials Network. All Rights Reserved. LABORATORY ERRORS: FINDING THE ROOT CAUSE Ask “Why” 5 Times • Write down the specific problem • Ask why the problem happened • Write down the answer • If the answer doesn’t identify the root cause of the HEMATOLOGY, CHEMISTRY, COAGULATION Hematology • The laboratory must verify calibration on the instrument every 6 months or on an “as needed” basis to ensure accuracy of the system. EVALUATING WET MOUNTS FOR THE PRESENCE OF CLUE CELLS • To clinically diagnose bacterial vaginosis (BV), Amsel’s criteria is used. • One of the four criteria, the presence of > 20% clue cells per field can be difficult to determine. HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
RESEARCH | MICROBICIDE TRIALS NETWORK MTN studies are designed specifically to support the potential licensure and regulatory approval of promising microbicides applied inside the vagina or rectum to prevent the sexual transmission of HIV. MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
SECTION 8. ADVERSE EVENT REPORTING AND SAFETY MONITORING MTN-034 SSP Manual Version 1.4, Protocol Version 2.0 05JAN2021 Section 8 Page 8-3 of 8-23 • Is a congenital anomaly/birth defect SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 SECTION 11. DATA COLLECTION MTN-043 SSP Manual Version 1.1, Protocol Version 1.0 29 January 2021 Section 11 Page 11-2 of 11-19 11.1 Medidata Rave Overview Medidata Rave is the data management system used by SCHARP to receive andmanage study data
STANDARD OPERATING PROCEDURE: SOURCE DOCUMENTATION Source Documentation SOP Addenda Requirement • If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional entry or addendum to the source documentation. The later entry must be signed/initialed anddated.
SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. HEMATOLOGY, CHEMISTRY, COAGULATION Hematology • The laboratory must verify calibration on the instrument every 6 months or on an “as needed” basis to ensure accuracy of the system. HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
RESEARCH | MICROBICIDE TRIALS NETWORK MTN studies are designed specifically to support the potential licensure and regulatory approval of promising microbicides applied inside the vagina or rectum to prevent the sexual transmission of HIV. MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
SECTION 8. ADVERSE EVENT REPORTING AND SAFETY MONITORING MTN-034 SSP Manual Version 1.4, Protocol Version 2.0 05JAN2021 Section 8 Page 8-3 of 8-23 • Is a congenital anomaly/birth defect SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 SECTION 11. DATA COLLECTION MTN-043 SSP Manual Version 1.1, Protocol Version 1.0 29 January 2021 Section 11 Page 11-2 of 11-19 11.1 Medidata Rave Overview Medidata Rave is the data management system used by SCHARP to receive andmanage study data
STANDARD OPERATING PROCEDURE: SOURCE DOCUMENTATION Source Documentation SOP Addenda Requirement • If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional entry or addendum to the source documentation. The later entry must be signed/initialed anddated.
SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. HEMATOLOGY, CHEMISTRY, COAGULATION Hematology • The laboratory must verify calibration on the instrument every 6 months or on an “as needed” basis to ensure accuracy of the system. STUDIES | MICROBICIDE TRIALS NETWORK A phase 1 clinical trial to evaluate the safety and immunogenicity of DNA/NYVAC prime boost vaccination with or without oral emtricitabine/tenofovir or vaginal tenofovir 1% gel in healthy, HIV-1–uninfected adult female participants. Phase 2 Adherence and Pharmacokinetics Study MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034. MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). The primary objectives of MTN-034 are to collectsafety and
MTN-043 STUDY IMPLEMENTATION MATERIALS Lab/Sample Collection; AVERY L7656 Labels or Equivalent (for A4 paper) 2020-01-28: 282.5 KB: MTN Laboratory Center HIV Testing Notification & Query Form : 2016-04-13 MANUAL OF OPERATIONAL PROCEDURES Section 01: Network Overview and Structure (Download) 2019-05-31. 301.47 KB. Section 02: Network Executive Committee (Download) 2019-05-31. 93.03 KB. Section 03: Network Operational Components (Download) 2019-05-31. 342.53 KB. SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.MTN-023/IPM 030
MTN-023/IPM 030 was a multi-center, two-arm, randomized, double-blind, placebo-controlled Phase 2a trial. The study enrolled 96 healthy, HIV-uninfected adolescent females, 15 - 17 years old (inclusive). Participants were randomized in a 3:1 ratio to one of the following study groups: dapivirine (25 mg) VR or KAMWALA HEALTH CENTRE CRS Microbicide Trials Network. All Rights Reserved. LABORATORY ERRORS: FINDING THE ROOT CAUSE Ask “Why” 5 Times • Write down the specific problem • Ask why the problem happened • Write down the answer • If the answer doesn’t identify the root cause of the HEMATOLOGY, CHEMISTRY, COAGULATION Hematology • The laboratory must verify calibration on the instrument every 6 months or on an “as needed” basis to ensure accuracy of the system. EVALUATING WET MOUNTS FOR THE PRESENCE OF CLUE CELLS • To clinically diagnose bacterial vaginosis (BV), Amsel’s criteria is used. • One of the four criteria, the presence of > 20% clue cells per field can be difficult to determine. HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
RESEARCH | MICROBICIDE TRIALS NETWORK MTN studies are designed specifically to support the potential licensure and regulatory approval of promising microbicides applied inside the vagina or rectum to prevent the sexual transmission of HIV. MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
SECTION 8. ADVERSE EVENT REPORTING AND SAFETY MONITORING MTN-034 SSP Manual Version 1.4, Protocol Version 2.0 05JAN2021 Section 8 Page 8-3 of 8-23 • Is a congenital anomaly/birth defect SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 SECTION 11. DATA COLLECTION MTN-043 SSP Manual Version 1.1, Protocol Version 1.0 29 January 2021 Section 11 Page 11-2 of 11-19 11.1 Medidata Rave Overview Medidata Rave is the data management system used by SCHARP to receive andmanage study data
STANDARD OPERATING PROCEDURE: SOURCE DOCUMENTATION Source Documentation SOP Addenda Requirement • If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional entry or addendum to the source documentation. The later entry must be signed/initialed anddated.
SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. HEMATOLOGY, CHEMISTRY, COAGULATION Hematology • The laboratory must verify calibration on the instrument every 6 months or on an “as needed” basis to ensure accuracy of the system. HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
RESEARCH | MICROBICIDE TRIALS NETWORK MTN studies are designed specifically to support the potential licensure and regulatory approval of promising microbicides applied inside the vagina or rectum to prevent the sexual transmission of HIV. MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
SECTION 8. ADVERSE EVENT REPORTING AND SAFETY MONITORING MTN-034 SSP Manual Version 1.4, Protocol Version 2.0 05JAN2021 Section 8 Page 8-3 of 8-23 • Is a congenital anomaly/birth defect SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 SECTION 11. DATA COLLECTION MTN-043 SSP Manual Version 1.1, Protocol Version 1.0 29 January 2021 Section 11 Page 11-2 of 11-19 11.1 Medidata Rave Overview Medidata Rave is the data management system used by SCHARP to receive andmanage study data
STANDARD OPERATING PROCEDURE: SOURCE DOCUMENTATION Source Documentation SOP Addenda Requirement • If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional entry or addendum to the source documentation. The later entry must be signed/initialed anddated.
SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. HEMATOLOGY, CHEMISTRY, COAGULATION Hematology • The laboratory must verify calibration on the instrument every 6 months or on an “as needed” basis to ensure accuracy of the system. STUDIES | MICROBICIDE TRIALS NETWORK A phase 1 clinical trial to evaluate the safety and immunogenicity of DNA/NYVAC prime boost vaccination with or without oral emtricitabine/tenofovir or vaginal tenofovir 1% gel in healthy, HIV-1–uninfected adult female participants. Phase 2 Adherence and Pharmacokinetics Study MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034. MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). The primary objectives of MTN-034 are to collectsafety and
MTN-043 STUDY IMPLEMENTATION MATERIALS Lab/Sample Collection; AVERY L7656 Labels or Equivalent (for A4 paper) 2020-01-28: 282.5 KB: MTN Laboratory Center HIV Testing Notification & Query Form : 2016-04-13 MANUAL OF OPERATIONAL PROCEDURES Section 01: Network Overview and Structure (Download) 2019-05-31. 301.47 KB. Section 02: Network Executive Committee (Download) 2019-05-31. 93.03 KB. Section 03: Network Operational Components (Download) 2019-05-31. 342.53 KB. SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.MTN-023/IPM 030
MTN-023/IPM 030 was a multi-center, two-arm, randomized, double-blind, placebo-controlled Phase 2a trial. The study enrolled 96 healthy, HIV-uninfected adolescent females, 15 - 17 years old (inclusive). Participants were randomized in a 3:1 ratio to one of the following study groups: dapivirine (25 mg) VR or KAMWALA HEALTH CENTRE CRS Microbicide Trials Network. All Rights Reserved. LABORATORY ERRORS: FINDING THE ROOT CAUSE Ask “Why” 5 Times • Write down the specific problem • Ask why the problem happened • Write down the answer • If the answer doesn’t identify the root cause of the HEMATOLOGY, CHEMISTRY, COAGULATION Hematology • The laboratory must verify calibration on the instrument every 6 months or on an “as needed” basis to ensure accuracy of the system. EVALUATING WET MOUNTS FOR THE PRESENCE OF CLUE CELLS • To clinically diagnose bacterial vaginosis (BV), Amsel’s criteria is used. • One of the four criteria, the presence of > 20% clue cells per field can be difficult to determine. HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034. MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). The primary objectives of MTN-034 are to collectsafety and
MTN-043 | MICROBICIDE TRIALS NETWORK MTN-043. MTN-043 is a Phase 3B, open-label, randomized (3:1), multi-site, mother-infant pair PK study designed to assess the safety, PK, adherence, and acceptability of the 25 mg dapivirine VR inserted every 4-weeks and the once-daily Truvada (200 mg FTC/300 mg TDF) tablet used by women from sub-Saharan countries during breastfeeding.MTN-043 PROTOCOLS
Microbicide Trials Network. All Rights Reserved.CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 KAMWALA HEALTH CENTRE CRS Microbicide Trials Network. All Rights Reserved.TONGAAT CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 LABORATORY ERRORS: FINDING THE ROOT CAUSE Ask “Why” 5 Times • Write down the specific problem • Ask why the problem happened • Write down the answer • If the answer doesn’t identify the root cause of the POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034. MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). The primary objectives of MTN-034 are to collectsafety and
MTN-043 | MICROBICIDE TRIALS NETWORK MTN-043. MTN-043 is a Phase 3B, open-label, randomized (3:1), multi-site, mother-infant pair PK study designed to assess the safety, PK, adherence, and acceptability of the 25 mg dapivirine VR inserted every 4-weeks and the once-daily Truvada (200 mg FTC/300 mg TDF) tablet used by women from sub-Saharan countries during breastfeeding.MTN-043 PROTOCOLS
Microbicide Trials Network. All Rights Reserved.CHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 KAMWALA HEALTH CENTRE CRS Microbicide Trials Network. All Rights Reserved.TONGAAT CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 LABORATORY ERRORS: FINDING THE ROOT CAUSE Ask “Why” 5 Times • Write down the specific problem • Ask why the problem happened • Write down the answer • If the answer doesn’t identify the root cause of the POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the STUDIES | MICROBICIDE TRIALS NETWORK A phase 1 clinical trial to evaluate the safety and immunogenicity of DNA/NYVAC prime boost vaccination with or without oral emtricitabine/tenofovir or vaginal tenofovir 1% gel in healthy, HIV-1–uninfected adult female participants. Phase 2 Adherence and Pharmacokinetics Study MTN-039 | MICROBICIDE TRIALS NETWORK MTN-039. MTN-039 was ad Phase 1, open-label, multi-site single arm, two-period study designed to evaluate the safety and pharmacokinetics (PK) of Tenofovir Alafenamide (TAF) and elvitegravir (EVG) administered rectally as an insert at two dose levels. Elvitegravir is MTN-043 STUDY IMPLEMENTATION MATERIALS Lab/Sample Collection; AVERY L7656 Labels or Equivalent (for A4 paper) 2020-01-28: 282.5 KB: MTN Laboratory Center HIV Testing Notification & Query Form : 2016-04-13 MANUAL OF OPERATIONAL PROCEDURES Section 01: Network Overview and Structure (Download) 2019-05-31. 301.47 KB. Section 02: Network Executive Committee (Download) 2019-05-31. 93.03 KB. Section 03: Network Operational Components (Download) 2019-05-31. 342.53 KB. MTN-037 | MICROBICIDE TRIALS NETWORK MTN-037. MTN-037 is a Phase 1, open label, sequential dose/volume escalation study designed to evaluate the safety and pharmacokinetics of PC-1005 (MIV-150/zinc acetate/carrageenan gel) when administered rectally. Approximately 12 healthy, HIV-uninfected men and women (cis or transgender) who are 18 years of age or older and who have ahistory
MTN-034 SSP MANUAL VERSION 1.3, PROTOCOL VERSION 2.0 MTN-034 SSP Manual Version 1.3, Protocol Version 2.0 22JUL2020 Section 5 Page 5-2 of 5-17 must establish a SOP that describes how site staff will fulfill the responsibility of determining SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks. SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the REQUIREMENTS FOR SOURCE DOCUMENTATION IN DAIDS FUNDED AND POLICY No.: DWD-POL-CL-04.00 Requirements for Source Documentation in DAIDS Funded and/or Sponsored Clinical Trials Page 1 of 4 DAIDS Bethesda, MD USA Approval Date: 20 DEC 06 HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
STUDIES | MICROBICIDE TRIALS NETWORK A phase 1 clinical trial to evaluate the safety and immunogenicity of DNA/NYVAC prime boost vaccination with or without oral emtricitabine/tenofovir or vaginal tenofovir 1% gel in healthy, HIV-1–uninfected adult female participants. Phase 2 Adherence and Pharmacokinetics Study MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034. MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). The primary objectives of MTN-034 are to collectsafety and
MTN-043 STUDY IMPLEMENTATION MATERIALS Lab/Sample Collection; AVERY L7656 Labels or Equivalent (for A4 paper) 2020-01-28: 282.5 KB: MTN Laboratory Center HIV Testing Notification & Query Form : 2016-04-13 MTN-039 | MICROBICIDE TRIALS NETWORK MTN-039. MTN-039 was ad Phase 1, open-label, multi-site single arm, two-period study designed to evaluate the safety and pharmacokinetics (PK) of Tenofovir Alafenamide (TAF) and elvitegravir (EVG) administered rectally as an insert at two dose levels. Elvitegravir isCHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356TONGAAT CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 STANDARD OPERATING PROCEDURE: SOURCE DOCUMENTATION Source Documentation SOP Addenda Requirement • If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional entry or addendum to the source documentation. The later entry must be signed/initialed anddated.
POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the HOMEPAGE | MICROBICIDE TRIALS NETWORKNETWORKRESEARCHPEOPLEMEETINGSRESOURCESWORKING GROUPS In the News. 10,000-plus medical charts provides comparator for HIV prevention study in pregnant women. 90-day dapivirine ring for women's HIV prevention passes its first test in Phase I study. One Size Doesn't Fit All When It Comes to Products for Preventing HIV from AnalSex.
MTN-042 | MICROBICIDE TRIALS NETWORK MTN-042 is a Phase 3b, open-label, multi-site, randomized (2:1 in Cohorts 1-2 and 4:1 in Cohort 3) trial designed to assess the safety, adherence and acceptability profiles of the 25 mg dapivirine VR and Truvada (200 mg FTC/300 mg TDF) oral tablet when used duringpregnancy.
STUDIES | MICROBICIDE TRIALS NETWORK A phase 1 clinical trial to evaluate the safety and immunogenicity of DNA/NYVAC prime boost vaccination with or without oral emtricitabine/tenofovir or vaginal tenofovir 1% gel in healthy, HIV-1–uninfected adult female participants. Phase 2 Adherence and Pharmacokinetics Study MTN-034 | MICROBICIDE TRIALS NETWORK MTN-034. MTN-034 is a Phase 2a, multi-site, randomized, open-label, crossover study to assess safety and adherence of a dapivirine vaginal ring and oral emtricitabine/tenofovir (FTC/TDF) tablets in HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). The primary objectives of MTN-034 are to collectsafety and
MTN-043 STUDY IMPLEMENTATION MATERIALS Lab/Sample Collection; AVERY L7656 Labels or Equivalent (for A4 paper) 2020-01-28: 282.5 KB: MTN Laboratory Center HIV Testing Notification & Query Form : 2016-04-13 MTN-039 | MICROBICIDE TRIALS NETWORK MTN-039. MTN-039 was ad Phase 1, open-label, multi-site single arm, two-period study designed to evaluate the safety and pharmacokinetics (PK) of Tenofovir Alafenamide (TAF) and elvitegravir (EVG) administered rectally as an insert at two dose levels. Elvitegravir isCHATSWORTH CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356TONGAAT CRS
South African Medical Research Council (MRC) CTU. CTU ID. 60356 STANDARD OPERATING PROCEDURE: SOURCE DOCUMENTATION Source Documentation SOP Addenda Requirement • If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional entry or addendum to the source documentation. The later entry must be signed/initialed anddated.
POWERPOINT PRESENTATION Participant Grid View The Participant Grid View: –Displays participant folders and forms in a grid format –Provides the status of specific forms –Allows authorized Rave users to quickly perform activities such a freeze, sign-off, verify, and sign-off on multiple forms –E.g., Investigator role can quickly sign-off on multiple eCRFs for a given participant at the RESEARCH | MICROBICIDE TRIALS NETWORK Studies. MTN studies are designed specifically to support the potential licensure and regulatory approval of promising microbicides applied inside the vagina or rectum to prevent the sexual transmissionof HIV.
MTN-037 | MICROBICIDE TRIALS NETWORK MTN-037. MTN-037 is a Phase 1, open label, sequential dose/volume escalation study designed to evaluate the safety and pharmacokinetics of PC-1005 (MIV-150/zinc acetate/carrageenan gel) when administered rectally. Approximately 12 healthy, HIV-uninfected men and women (cis or transgender) who are 18 years of age or older and who have ahistory
MTN-045 | MICROBICIDE TRIALS NETWORK MTN-045. MTN-045 is a cross-sectional study that will include questionnaires with both partners of the couple - individually and together- including a Discrete-Choice Experiment (DCE) that assesses attribute preferences. Post-survey explanatory IDIs will be conducted with a subset of couples (N=20-40). MPT product forms evaluated willbe
MTN-043 PROTOCOLS
Microbicide Trials Network. All Rights Reserved. MU-JHU RESEARCH COLLABORATION CRS Location. Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration CRS. Upper Mulago Hill Road. P. O. Box 23491.Kampala. Uganda.
SITE FDA INSPECTION PREPARATION CHECKLISTWEB VIEW Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks. STANDARD OPERATING PROCEDURE: SOURCE DOCUMENTATION Source Documentation SOP Addenda Requirement • If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional entry or addendum to the source documentation. The later entry must be signed/initialed anddated.
SAMPLE SOP FOR SAFETY MONITORING AND REPORTINGWEB VIEW Purpose. To define procedures for monitoring participant safety and taking action in response to potential safety concerns in MTN-020. Scope. This standard operating procedure (SOP) applies to all study staff involved in MTN-020. KAMWALA HEALTH CENTRE CRS Microbicide Trials Network. All Rights Reserved. SECTION 8. CLINICAL CONSIDERATIONS MTN-036/IPM 047 SSP Manual Version 1.1 22 May 2018 Section 8 Page 8-2 existing conditions. Pre-existing conditions must be graded and are assigned severity grades Skip to main contentUSER ACCOUNT MENU
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As individuals, communities and nations, COVID-19 is having a profound impact on our lives. What we are experiencing as a global society is unprecedented. As a network dedicated to protecting people particularly vulnerable to HIV, MTN is committed to ensuring our site staff, research teams and participants are supported and not put in harm’s way, as well as seeing that the scientific integrity of our research is protected. To keep updated on the impact of the COVID-19 pandemic on our studies, visit our COVID-19 Response page.
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RESEARCH HIGHLIGHTS
Spotlight on MTN-041 A cisgender woman who is eight months pregnant was the first participant enrolled into MTN-042 (DELIVER) which launchedmid-February.
MTN-045 has launched. MTN is pleased to announce the launch of MTN-039.NETWORK NOTES
MTN Regional Meeting Cancelled. Remembering Gita Ramjee.COVID-19 Response.
IN THE NEWS
REACH-ing beyond expectations Researchers launch DELIVER study to assess safety of PrEP and dapivirine vaginal ring in pregnant women Results of open-label study of a vaginal ring for HIV prevention suggest women are interested in and willing to use itSTUDIES ENROLLING
None at this time.
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