ACASI Questionnaire Schedule - Oral

Slides:



Advertisements
Similar presentations
1 MTN-003 Training Follow-up Visit Scheduling and Visit Coding SSP Sections and
Advertisements

Overview of Follow-up Visit Types and Visit Scheduling Training Binder Tab: Follow-up Visits.
ASPIRE Off-Site Visits. Rationale Why make an allowance for off-site visits in the protocol? Adherence & Retention Off-site visits Improving Clinic Flow.
HIV Counseling &Testing. Page 346 HIV and Risk Reduction (RR) Counseling Required at all scheduled visits Includes HIV Pre- and Post-test counseling.
1 MTN-003 Study Specific Training Randomization Overview.
AEs, SAEs, and EAEs – An Overview
Contraception/Pregnancies MTN 020. Why do we care? Participants must come off product during pregnancy and breastfeeding – Studies of dapivirine in pregnant.
Baseline Medical and Menstrual History The ins, outs, ups, and downs of collecting a relevant and complete baseline medical/menstrual history MTN 020 Training.
Genital Bleeding MTN 020 Training. Background  Genital Bleeding is common Includes menses Includes intermenstrual bleeding (IMB)  Determining whether.
The Federal Register and the Unified Agenda Carol Bednar July 26, 2006 Reference Retreat.
Expectations of Provider Reviews Missouri Medicaid Audit & Compliance Unit (MMAC) Provider Enrollment Contracts & Terminations Provider Review & Lock-in.
1 MTN 003 Data Management Considerations SSP Sections 14, 15 & 17.
ASPIRE TRAINING Study Product Considerations & Accountability for Non-Pharmacy Staff.
Retention: Feedback to Sites and Feedback to Sites and Participant Tracking Database.
Product Use Management MTN 020 Training. Objectives- study product tab  Identify the conditions that would require a product hold or discontinuation.
Chapter 6 Exponential and Logarithmic Functions and Applications Section 6.5.
Participant Accrual. Numbers that Matter 3476= total number of women enrolled at least 95% retention at each visit, at each study site 100% attention.
Overview of Enrollment Procedures. Training Materials for this session  All materials for this session can be found under the Enrollment tab of your.
Follow-up Visit Procedures MTN-028 Study Specific Training.
PAST SIMPLE TENSE.
Informed Consent Process: Key Considerations. Introduction  Informed consent is a requirement of ethical clinical research  Section 4.8 of the International.
Types of Compound Interest Compound Annually= Once per year Compound Semi-annually= 2 times per year Compound Quarterly= 4 times per year Compound Monthly=
Study Product Return Re-Supply and Re-Issue MTN-003 Study-Specific Training.
Participant Retention Plans MTN-003 Study-Specific Training.
MTN-027 Clinical Management CRFs. CRFs for Clinical Management Physical Exam Pelvic Exam Diagrams Pelvic Exam Pelvic Exam Ring Assessment Clinical Product.
Commuting Scheme Commuting Scheme  6 weeks ON + 2 working days, then 2 weeks OFF + 2 soft days. Scheme A: 44 days ON, 16 days OFF Scheme B: 39 days ON,
**INSERT YOUR TITLE HERE**
Microbicides The Population Council Experience and Future Directions Don E. Waldron Medical Director Don E. Waldron Medical Director.
Social Harms Reporting in ASPIRE Training Binder p.275.
Baseline Medical and Menstrual History The ins, outs, ups, and downs of collecting a relevant and complete baseline medical/menstrual history MTN 020 Training.
Follow-up Case Report Forms SCHARP. Follow-up Visit CRFs Monthly Visits Date of Visit Follow-up Visit Summary Ring Adherence (Y/N) prompt Laboratory Results.
Protocol Requirements for Product Holds/Discontinuations MTN-025.
1 HOPE Product Use Management: HIV Infection no rapid test(s) positive CONTINUE product. HOLD product pending confirmatory testing. PERMANENTLY DISCONTINUE.
ESE 697 Week 2 Assignment Lesson Plan 2 Phonics or Oral Language Check this A+ tutorial guideline at ASH/ESE-697-Week-2-Assignment-Lesson-Plan-2-
Planning for HOPE PUEVs and Study Exit Visits
Overview of Visit Scheduling and Types of Follow-up Visits SCHARP
HOPE SSP Updates May 2017.
Management of Pregnancies
Presentation to Early Childhood ADVISORY COMMITTEE (ECAC) Family Start Budget 17 Presentation to Early Childhood Advisory Committee re Family.
MTN-036 Study of Extended Duration Dapivirine Vaginal Ring for HIV Prevention How do I know if I’m Eligible to join? Women who join the study must.
Expedited Adverse Event Reporting Requirements
Protocol References Section Title 6.2 Entry Visit 5.1
HOPE STUDY PRODUCT TRAINING PHASE 2
Protocol References Section Title 6.2 Entry Visit 5.1
Expedited Adverse Event Reporting Requirements
MTN-025 (HOPE Study) Community Education Presentation
ACC 2003 Innovative Education--snaptutorial.com
TECHjOSH.COM TechJosh.com.
GSCM 530 Innovative Education--snaptutorial.com
MTH 530 Enthusiastic Study/snaptutorial.com
ITS 1103 Enthusiastic Study/snaptutorial.com
MGT 3035 Enthusiastic Studysnaptutorial.com
MTN-037 Study Product Considerations
Ariana Katz WGHI/RTI International San Francisco, CA
2.6: Data System Business Process Maps
Present Value Time Value of Money.
Benefits Cost Quality of Life
CHAPTER TEN COMPOUND INTEREST.
Administering Behavioral CRFs
The Tutorial Process.
College Lane Surgery Patient Participation Group
Participant Retention
Using the Feature Article as a tool for collaboration
2.6: Data System Business Process Maps
Интерпретация және зерттеу нәтижесін өңдеу
HOPE STUDY PRODUCT TRAINING
Annuities, Stocks, and Bonds
ASPIRE Common QCs - PUEV and SEV
What’s your nationality? Where are you from?
Mean BP by visit - all patients
Presentation transcript:

ACASI Questionnaire Schedule - Oral Visit Visit Code ACASI Questionnaire to administer Administer to: Enrollment 3.0 All participants enrolled Month 3* 6.0 First Quarterly Oral All participants randomized to oral arm (unless product continuously held/discontinued past 4 weeks) Months 6, 9, 15, 18, 21, 27, 30 9.0, 12.0, 18.0, 21.0, 24.0, 30.0, 33.0 Regular Quarterly Oral Months 12, 24, and PUEV/Early Termination 15.0, 27.0, visit code associated with study month when PUEV/Early Termination occurs** Annual/PUEV Oral All participants randomized to oral arm who are completing an annual visit, scheduled PUEV, or early termination visit (unless product continuously held/discontinued past 4 weeks) Study Exit (SEV) or any quarterly or semiannual visit where participant has been on continuous product hold/ discontinuation for the past 4 weeks 89.0, visit code associated with study month when quarterly or semiannual visit occurs** Product Hold/ Discontinuers/SEV Participants randomized to oral arm who are completing a scheduled SEV, who have had product continuously held by site staff for 4 weeks or more, or who have permanently discontinued study product (site or participant choice) 4 or more weeks ago * If participant misses her Month 3 Visit, administer the First Quarterly Oral ACASI questionnaire at the first quarterly visit she completes. **Refer to SSP Section Table 14-2 for the list of visit codes assigned to each study visit

ACASI Questionnaire Schedule - Vaginal Visit Visit Code ACASI Questionnaire to administer Administer to: Enrollment 3.0 All participants enrolled Month 3* 6.0 First Quarterly Vaginal All participants randomized to vaginal arm (unless product continuously held/discontinued past 4 weeks) Months 6, 9, 15, 18, 21, 27, 30 9.0, 12.0, 18.0, 21.0, 24.0, 30.0, 33.0 Regular Quarterly Vaginal Months 12, 24, and PUEV/Early Termination 15.0, 27.0, visit code associated with study month when PUEV/Early Termination occurs** Annual/PUEV Vaginal All participants randomized to vaginal arm who are completing an annual visit, scheduled PUEV, or early termination visit (unless product continuously held/discontinued past 4 weeks) Study Exit (SEV) or any quarterly or semiannual visit where participant has been on continuous product hold/ discontinuation for the past 4 weeks 89.0, visit code associated with study month when quarterly or semiannual visit occurs** Product Hold/ Discontinuers/SEV Participants randomized to vaginal arm who are completing a scheduled SEV, who have had product continuously held by site staff for 4 weeks or more, or who have permanently discontinued study product (site or participant choice) 4 or more weeks ago * If participant misses her Month 3 Visit, administer the First Quarterly Vaginal ACASI questionnaire at the first quarterly visit she completes. **Refer to SSP Section Table 14-2 for the list of visit codes assigned to each study visit