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Regulatory Requirements and Guidelines for DSMB PowerPoint PPT Presentation
Regulatory Requirements and Guidelines for DSMB - Regulatory Requirements and Guidelines for DSMB s .Or who-advises-what in regard to DSMB s Regulatory Requirements and Guidelines for DSMB s All sorts ...
Regulatory Requirements and Guidelines for DSMB s .Or who-advises-what in regard to DSMB s Regulatory Requirements and Guidelines for DSMB s All sorts ...
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INTERGROUP STUDY 0148 BMS CA139223 Effect of TAXOL paclitaxel and Doxorubicin Dose on Disease Free a PowerPoint PPT Presentation
INTERGROUP STUDY 0148 BMS CA139223 Effect of TAXOL paclitaxel and Doxorubicin Dose on Disease Free a - Based on pre-planned interim analysis at 453 events, DSMB decided in March 1998 ... October 1998 Pre-sNDA meeting with FDA. December 1998 Study database update ...
Based on pre-planned interim analysis at 453 events, DSMB decided in March 1998 ... October 1998 Pre-sNDA meeting with FDA. December 1998 Study database update ...
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Male Circumcision And HIV Prevention: A Cutting Edge Intervention PowerPoint PPT Presentation
Male Circumcision And HIV Prevention: A Cutting Edge Intervention - Trial was stopped early by the DSMB after interim analysis... If one or both show a protective effect, the interest in implementing MC ...
Trial was stopped early by the DSMB after interim analysis... If one or both show a protective effect, the interest in implementing MC ...
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The Challenge to Develop Systems of Care for STEMI Patients: PowerPoint PPT Presentation
The Challenge to Develop Systems of Care for STEMI Patients: - Including Lessons Learned from Stroke Systems of Care. Alice K. ... Moyer. Crit Pathways in Cardiol 2004;3:53-61. Registry/Data center. DSMB. Minimal standards: ...
Including Lessons Learned from Stroke Systems of Care. Alice K. ... Moyer. Crit Pathways in Cardiol 2004;3:53-61. Registry/Data center. DSMB. Minimal standards: ...
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Data Management for Health Sciences Research PowerPoint PPT Presentation
Data Management for Health Sciences Research - HIPAA Regulations / IRBs / DSMBs / PSMBs/Data Sharing. May 9, ... Use of sophisticated data management software is becoming the rule rather than the exception ...
HIPAA Regulations / IRBs / DSMBs / PSMBs/Data Sharing. May 9, ... Use of sophisticated data management software is becoming the rule rather than the exception ...
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Data Management Issues PowerPoint PPT Presentation
Data Management Issues - Members have been chosen to be (relatively) free of conflicts of interest ... Best practice: prepare DSMB report templates before data are available ...
Members have been chosen to be (relatively) free of conflicts of interest ... Best practice: prepare DSMB report templates before data are available ...
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NHLBI CLINICAL RESEARCH NETWORKS PowerPoint PPT Presentation
NHLBI CLINICAL RESEARCH NETWORKS - Peer Review. 4. 8. Council. Finalize Protocol, DSMB, etc. 12. 16. Council. NIH Guide. Funding ... Protocol Review Committee. Data and Safety Monitoring Board ...
Peer Review. 4. 8. Council. Finalize Protocol, DSMB, etc. 12. 16. Council. NIH Guide. Funding ... Protocol Review Committee. Data and Safety Monitoring Board ...
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BREAD at UCSF PowerPoint PPT Presentation
BREAD at UCSF - Stimulate discussion/research of difficult research ethics ... Clinical trials, DSMB. 4. Distinguish. IRB approval and process. Compliance. Consent monitoring ...
Stimulate discussion/research of difficult research ethics ... Clinical trials, DSMB. 4. Distinguish. IRB approval and process. Compliance. Consent monitoring ...
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The Life Cycle of a Protocol Review Process PowerPoint PPT Presentation
The Life Cycle of a Protocol Review Process - Can be either dropped off at the IRB office OR can be left at A-128 for pick up ... Adverse Event Summary Table, GCRC Addendum, and DSMB reports (when applicable) ...
Can be either dropped off at the IRB office OR can be left at A-128 for pick up ... Adverse Event Summary Table, GCRC Addendum, and DSMB reports (when applicable) ...
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Urban Latino African American Cancer Disparity Project PowerPoint PPT Presentation
Urban Latino African American Cancer Disparity Project - Title: Urban Latino African American Cancer Disparity Project Author: Kristin Muller Created Date: 1/7/2004 6:53:11 AM Document presentation format
Title: Urban Latino African American Cancer Disparity Project Author: Kristin Muller Created Date: 1/7/2004 6:53:11 AM Document presentation format
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How%20would%20you%20revise%20the%20human%20subject%20research%20regulations? PowerPoint PPT Presentation
How%20would%20you%20revise%20the%20human%20subject%20research%20regulations? - Rapid and unprecedented demographic changes challenge our assumptions ... Jane E. Allen, LA Times, November 6, 2000. L.A. Workers Held Back By Low Education Rate ...
Rapid and unprecedented demographic changes challenge our assumptions ... Jane E. Allen, LA Times, November 6, 2000. L.A. Workers Held Back By Low Education Rate ...
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Clinical Trials and Research PowerPoint PPT Presentation
Clinical Trials and Research - Clinical Trials and Research A Guide for Community Advisory Board Members Trainer Manual * Researchers assign participants to a medicine group at random.
Clinical Trials and Research A Guide for Community Advisory Board Members Trainer Manual * Researchers assign participants to a medicine group at random.
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Community outreach in MRC national and international trials PowerPoint PPT Presentation
Community outreach in MRC national and international trials - Paediatric HIV Care Author: Polly Clayden Last ... Times Arial Times New Roman Blank Presentation Community outreach in MRC national and international trials ...
Paediatric HIV Care Author: Polly Clayden Last ... Times Arial Times New Roman Blank Presentation Community outreach in MRC national and international trials ...
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Just How Flexible Can a Prospective Clinical Trial Be? PowerPoint PPT Presentation
Just How Flexible Can a Prospective Clinical Trial Be? - Characterized by a ready capability to adapt to new, different, or changing requirements ... The adaptive path is treacherous, with mines every step of the way ...
Characterized by a ready capability to adapt to new, different, or changing requirements ... The adaptive path is treacherous, with mines every step of the way ...
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What the GCRC Can Do for You: Research Subject Advocate PowerPoint PPT Presentation
What the GCRC Can Do for You: Research Subject Advocate - The NIH policy for data and safety monitoring of all clinical intervention ... http://grants.nih.gov/grants/guide/notice-files/not98-084.html ...
The NIH policy for data and safety monitoring of all clinical intervention ... http://grants.nih.gov/grants/guide/notice-files/not98-084.html ...
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Measurement and Evaluation M PowerPoint PPT Presentation
Measurement and Evaluation M - Psychometrics. Statistics. Barker. Featherstone. Weintraub, Isong. Mertz. Meyer (consultant) ... Using secure web-based system with SAS back-end & firewall ...
Psychometrics. Statistics. Barker. Featherstone. Weintraub, Isong. Mertz. Meyer (consultant) ... Using secure web-based system with SAS back-end & firewall ...
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Lecture Seventeen: PowerPoint PPT Presentation
Lecture Seventeen: - Biomedical Engineering for Global Health Lecture Seventeen: Clinical Trials ...
Biomedical Engineering for Global Health Lecture Seventeen: Clinical Trials ...
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OSTEOPOROSIS Ongoing Studies of Hormones and Alternative Therapies PowerPoint PPT Presentation
OSTEOPOROSIS Ongoing Studies of Hormones and Alternative Therapies - SELENA a trial of E P in postmenopausal women with Lupus (discontinued) ... The safety was being evaluated because lupus patients are: ...
SELENA a trial of E P in postmenopausal women with Lupus (discontinued) ... The safety was being evaluated because lupus patients are: ...
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Using an Independent Statistician to Support a Data Monitoring Committee PowerPoint PPT Presentation
Using an Independent Statistician to Support a Data Monitoring Committee - Using an Independent Statistician to Support a Data Monitoring Committee
Using an Independent Statistician to Support a Data Monitoring Committee
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Content of Regulatory/Study Binder PowerPoint PPT Presentation
Content of Regulatory/Study Binder - Content of Regulatory/Study Binder Human Subject Protection Office UConn Health Center Monika Haugstetter, MHA, RN, MSN & HSPO/IRB Staff Introduction * Definition ...
Content of Regulatory/Study Binder Human Subject Protection Office UConn Health Center Monika Haugstetter, MHA, RN, MSN & HSPO/IRB Staff Introduction * Definition ...
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Clinical Trials PowerPoint PPT Presentation
Clinical Trials - Clinical Trials - New Providence School District ... Clinical Trials
Clinical Trials - New Providence School District ... Clinical Trials
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Safety Reporting IN Clinical Trials PowerPoint PPT Presentation
Safety Reporting IN Clinical Trials - SAFETY REPORTING IN CLINICAL TRIALS * * Background Many agencies across the world have pharmacovigilance requirements. The Medicines for Human Use (Clinical Trials ...
SAFETY REPORTING IN CLINICAL TRIALS * * Background Many agencies across the world have pharmacovigilance requirements. The Medicines for Human Use (Clinical Trials ...
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VII-1 PowerPoint PPT Presentation
VII-1 - Compute the required sample size under a fixed sample design. Multiply this sample size by an appropriate ratio to account for the multiple testing. ...
Compute the required sample size under a fixed sample design. Multiply this sample size by an appropriate ratio to account for the multiple testing. ...
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IS IT ETHICAL?? IRB AND Human Subjects Challenges and NIH Grant Updates PowerPoint PPT Presentation
IS IT ETHICAL?? IRB AND Human Subjects Challenges and NIH Grant Updates - IS IT ETHICAL?? IRB AND Human Subjects Challenges and NIH Grant Updates Mayra Lomeli, MSRA, CCRC IRB Specialist Mary Woo, RN, DNSc, FAAN, FAHA Professor
IS IT ETHICAL?? IRB AND Human Subjects Challenges and NIH Grant Updates Mayra Lomeli, MSRA, CCRC IRB Specialist Mary Woo, RN, DNSc, FAAN, FAHA Professor
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Effect of Aleglitazar on Cardiovascular Outcomes After Acute Coronary Syndrome in Patients With Type 2 Diabetes Mellitus PowerPoint PPT Presentation
Effect of Aleglitazar on Cardiovascular Outcomes After Acute Coronary Syndrome in Patients With Type 2 Diabetes Mellitus - Effects of / PPAR Activation. Nuclear receptors that function as transcription factors regulating the expression of genes Insulin . sensitivity
Effects of / PPAR Activation. Nuclear receptors that function as transcription factors regulating the expression of genes Insulin . sensitivity
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Lessons from Vioxx PowerPoint PPT Presentation
Lessons from Vioxx - A copy of the presentation with hyperlinks to most of the documents cited can be ... Arthritis Rheum. 1999 Sep;42(9):1870-8. Comment in: Arthritis Rheum. ...
A copy of the presentation with hyperlinks to most of the documents cited can be ... Arthritis Rheum. 1999 Sep;42(9):1870-8. Comment in: Arthritis Rheum. ...
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The%20New%20England%20Children PowerPoint PPT Presentation
The%20New%20England%20Children - Funded by a cooperative agreement between the NIDCR and New ... N-acetyl- -D-glucosaminidase (NAG) Microalbuminuria. glomerular damage. proximal. tubule ...
Funded by a cooperative agreement between the NIDCR and New ... N-acetyl- -D-glucosaminidase (NAG) Microalbuminuria. glomerular damage. proximal. tubule ...
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Sharing Data on caGrid at the Mayo Clinic Cancer Center PowerPoint PPT Presentation
Sharing Data on caGrid at the Mayo Clinic Cancer Center - Sharing Data on caGrid at the Mayo Clinic Cancer Center. Issues and Challenges ... Mayo Clinic Cancer Center has been an active participant in multiple workspaces, ...
Sharing Data on caGrid at the Mayo Clinic Cancer Center. Issues and Challenges ... Mayo Clinic Cancer Center has been an active participant in multiple workspaces, ...
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SelfDesigning Trials: Further Thoughts PowerPoint PPT Presentation
SelfDesigning Trials: Further Thoughts - Introduction into the middle of a study without prior planning. Back to the basic idea ... Industry/FDA interactions have improved tremendously over the last 20 years ...
Introduction into the middle of a study without prior planning. Back to the basic idea ... Industry/FDA interactions have improved tremendously over the last 20 years ...
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Methods for Incorporating Flexibility in Clinical Trials PowerPoint PPT Presentation
Methods for Incorporating Flexibility in Clinical Trials - Methods for Incorporating Flexibility in Clinical Trials. Janet Wittes. BASS. Election Day 2004 ... Increase probability of assigning the best treatment to the ...
Methods for Incorporating Flexibility in Clinical Trials. Janet Wittes. BASS. Election Day 2004 ... Increase probability of assigning the best treatment to the ...
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ICSSC International Clinical Sciences Support Center PowerPoint PPT Presentation
ICSSC International Clinical Sciences Support Center - DMID contract for investigators funded by NIH/NIAID/DMID conducting ... Randomization and allocation concealment procedures. ICSSC Biostatistics Services (2) ...
DMID contract for investigators funded by NIH/NIAID/DMID conducting ... Randomization and allocation concealment procedures. ICSSC Biostatistics Services (2) ...
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Moduli ya 2 PowerPoint PPT Presentation
Moduli ya 2 - Moduli ya 2 Utangulizi kwa Jaribio la kitabibu Sehemu II Mwongozo wa mwezeshaji Trainer Manual for Community Advisory Boards Module 2: Introduction to Clinical Trials ...
Moduli ya 2 Utangulizi kwa Jaribio la kitabibu Sehemu II Mwongozo wa mwezeshaji Trainer Manual for Community Advisory Boards Module 2: Introduction to Clinical Trials ...
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Carotid Stent PowerPoint PPT Presentation
Carotid Stent - BBA is committed to principles of integrity, quality, and ... Gastroenterology /urology. Combination products. Biologic devices. Medical Device Experience ...
BBA is committed to principles of integrity, quality, and ... Gastroenterology /urology. Combination products. Biologic devices. Medical Device Experience ...
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Informed Consent, Institutional Review Boards, Data PowerPoint PPT Presentation
Informed Consent, Institutional Review Boards, Data - Seven Requirements for Ethical Clinical Trials. Social or scientific value ... informing subjects of results of clinical research; 5) maintaining welfare of ...
Seven Requirements for Ethical Clinical Trials. Social or scientific value ... informing subjects of results of clinical research; 5) maintaining welfare of ...
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ART initiated before 12 weeks reduces early mortality in young HIVinfected infants: evidence from th PowerPoint PPT Presentation
ART initiated before 12 weeks reduces early mortality in young HIVinfected infants: evidence from th - 11. Class B (%) (29 -43.8) 35.6 (29.1 - 40.8) 35.1. CD4 ... 5985 babies were screened using DNA PCR to enrol 377 HIV pos infants. 9. Follow-up and use of ART ...
11. Class B (%) (29 -43.8) 35.6 (29.1 - 40.8) 35.1. CD4 ... 5985 babies were screened using DNA PCR to enrol 377 HIV pos infants. 9. Follow-up and use of ART ...
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Evaluating the Role of Fixed Dose Combination Drugs and Issue of Drug Resistance in the Fight Agains PowerPoint PPT Presentation
Evaluating the Role of Fixed Dose Combination Drugs and Issue of Drug Resistance in the Fight Agains - Sponsored by the Children's AIDS Fund. Edmund C. Tramont, M.D.,F.A.C.P.. Director ... clinical research, protocol must undergo scientific review, approval by an IRB ...
Sponsored by the Children's AIDS Fund. Edmund C. Tramont, M.D.,F.A.C.P.. Director ... clinical research, protocol must undergo scientific review, approval by an IRB ...
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A Randomized Controlled Trial of Male Circumcision to Reduce HIV Incidence in Kisumu, Kenya PowerPoint PPT Presentation
A Randomized Controlled Trial of Male Circumcision to Reduce HIV Incidence in Kisumu, Kenya - A Randomized Controlled Trial of Male Circumcision to Reduce HIV Incidence in Kisumu, Kenya ... 6 post-operative wound infections (0.4%) 4 bleeding episodes (0.3 ...
A Randomized Controlled Trial of Male Circumcision to Reduce HIV Incidence in Kisumu, Kenya ... 6 post-operative wound infections (0.4%) 4 bleeding episodes (0.3 ...
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ETHICAL ISSUES IN CLINICAL RESEARCH PowerPoint PPT Presentation
ETHICAL ISSUES IN CLINICAL RESEARCH - ETHICAL ISSUES IN CLINICAL RESEARCH Peter Wagner, M.D. Dept of Medicine, UCSD President, American Thoracic Society Control Groups Proper design important to ...
ETHICAL ISSUES IN CLINICAL RESEARCH Peter Wagner, M.D. Dept of Medicine, UCSD President, American Thoracic Society Control Groups Proper design important to ...
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The Role of the IRB in Clinical Research PowerPoint PPT Presentation
The Role of the IRB in Clinical Research - Use a conventional or standard treatment ... of Vaccination with Synthetic Peptides in Patients with Advanced Colon Cancer ... Treatment is not covered by the study. ...
Use a conventional or standard treatment ... of Vaccination with Synthetic Peptides in Patients with Advanced Colon Cancer ... Treatment is not covered by the study. ...
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CLINICAL TRIALS OVERVIEW PowerPoint PPT Presentation
CLINICAL TRIALS OVERVIEW - The Way We Make Progress Against Disease. Research studies to find better ways to prevent, detect, or treat disease ... Pharmacokinetic/Pharmacodynamic analysis ...
The Way We Make Progress Against Disease. Research studies to find better ways to prevent, detect, or treat disease ... Pharmacokinetic/Pharmacodynamic analysis ...
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Drug Regulation in Controversy: Vioxx November 10, 2004 PowerPoint PPT Presentation
Drug Regulation in Controversy: Vioxx November 10, 2004 - Alzheimer's, polyps, prostate cancer. Focus on CV endpoint ... Mixed picture of CV risk. Merck submits more data from ongoing Alzheimer's Disease trials ...
Alzheimer's, polyps, prostate cancer. Focus on CV endpoint ... Mixed picture of CV risk. Merck submits more data from ongoing Alzheimer's Disease trials ...
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Final Results of a Phase II-a, Randomized, PowerPoint PPT Presentation
Final Results of a Phase II-a, Randomized, - Final Results of a Phase II-a, Randomized, Open-Label Trial to Evaluate Intramyocardial Autologous Skeletal Myoblast Transplantation in Congestive Heart Failure Patients:
Final Results of a Phase II-a, Randomized, Open-Label Trial to Evaluate Intramyocardial Autologous Skeletal Myoblast Transplantation in Congestive Heart Failure Patients:
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The Role of the IRB in Clinical Research PowerPoint PPT Presentation
The Role of the IRB in Clinical Research - One of 3 local Institutional Review Boards. ... Relative to time, effort, risk, and unpleasantness ... Allowable Use of Identifiable Personal Health Information ...
One of 3 local Institutional Review Boards. ... Relative to time, effort, risk, and unpleasantness ... Allowable Use of Identifiable Personal Health Information ...
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Study Monitoring PowerPoint PPT Presentation
Study Monitoring - Accrual too slow to complete in timely fashion ... Schering Plough News Release March 3, 2006 ... Schering Plough News Release March 3, 2006. What other ...
Accrual too slow to complete in timely fashion ... Schering Plough News Release March 3, 2006 ... Schering Plough News Release March 3, 2006. What other ...
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Johns Hopkins Institute for Clinical and Translational Research A CTSA Program PowerPoint PPT Presentation
Johns Hopkins Institute for Clinical and Translational Research A CTSA Program - ... Furth, Edgar Miller, Jon Samet, Scott Zeger, Jennifer Haythornwaite, Jeri Allen ... Leader: Scott Zeger ... Leader: Jeffrey Rothstein ...
... Furth, Edgar Miller, Jon Samet, Scott Zeger, Jennifer Haythornwaite, Jeri Allen ... Leader: Scott Zeger ... Leader: Jeffrey Rothstein ...
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Clinical Trials and Good Clinical Practice PowerPoint PPT Presentation
Clinical Trials and Good Clinical Practice - Clinical Trials and Good Clinical Practice M Suzanne Stratton, PhD Research Assistant Professor of Medicine Director, Prostate Cancer Prevention Program
Clinical Trials and Good Clinical Practice M Suzanne Stratton, PhD Research Assistant Professor of Medicine Director, Prostate Cancer Prevention Program
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The Difference Between Practice and Research What the FDA Expects You to Understand PowerPoint PPT Presentation
The Difference Between Practice and Research What the FDA Expects You to Understand - Harvey M. Arbit, PharmD, MBA, RAC, CCRP. University of Minnesota ... Attributable, Legible, Contemporaneous, Original, Accurate ...
Harvey M. Arbit, PharmD, MBA, RAC, CCRP. University of Minnesota ... Attributable, Legible, Contemporaneous, Original, Accurate ...
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Randomized Trials: When are they ethical When should they be stopped When should they be repeated PowerPoint PPT Presentation
Randomized Trials: When are they ethical When should they be stopped When should they be repeated - If trial shows benefit may inhibit randomized confirmation. ... 'Further randomized clinical trials using concurrent controls. ...
If trial shows benefit may inhibit randomized confirmation. ... 'Further randomized clinical trials using concurrent controls. ...
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Adult AIDS Clinical Trials Group International Therapeutic Initiative PowerPoint PPT Presentation
Adult AIDS Clinical Trials Group International Therapeutic Initiative - ... International Therapeutic Clinical Trials Initiative ... Pharma-independent sources of ARVs are needed for clinical trials in resource-limited settings ...
... International Therapeutic Clinical Trials Initiative ... Pharma-independent sources of ARVs are needed for clinical trials in resource-limited settings ...
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Epidemiologia de la IC avanzada PowerPoint PPT Presentation
Epidemiologia de la IC avanzada - Epidemiologia de la IC avanzada! Sobrevida TxC (0.001%)! 1 Cancer 0.8 0.6 IC Avanzada (0.1%) 0.4 0.2 IC Avanzada Insuficiencia Card aca (1-2 %) 0 0 12 24 36 48 60
Epidemiologia de la IC avanzada! Sobrevida TxC (0.001%)! 1 Cancer 0.8 0.6 IC Avanzada (0.1%) 0.4 0.2 IC Avanzada Insuficiencia Card aca (1-2 %) 0 0 12 24 36 48 60
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Conversemos un rato''' PowerPoint PPT Presentation
Conversemos un rato''' - Por qu hay pocos participantes hispanos/latinos en los estudios cl nicos? La familia ... Entre los hispanos/latinos es especial su: Ascendencia. Cultura ...
Por qu hay pocos participantes hispanos/latinos en los estudios cl nicos? La familia ... Entre los hispanos/latinos es especial su: Ascendencia. Cultura ...
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The impact of homebased care compared with facilitybased HIVcare on virologic failure and mortality: PowerPoint PPT Presentation
The impact of homebased care compared with facilitybased HIVcare on virologic failure and mortality: - Very severe shortages of doctors and nurses ... Rosette Kyomuhangi. Susie Foster. Geoffrey Namara. Nicaise Ndembi. Tom Eliatu, Pontiano Kaleebu, ...
Very severe shortages of doctors and nurses ... Rosette Kyomuhangi. Susie Foster. Geoffrey Namara. Nicaise Ndembi. Tom Eliatu, Pontiano Kaleebu, ...
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Johns Hopkins Bloomberg School of Public Health PowerPoint PPT Presentation
Johns Hopkins Bloomberg School of Public Health - Johns Hopkins Bloomberg School of Public Health Committee on Human Research Office for Research Subjects Brown Bag Series A HANDS-ON WORKSHOP: How to Write a Research ...
Johns Hopkins Bloomberg School of Public Health Committee on Human Research Office for Research Subjects Brown Bag Series A HANDS-ON WORKSHOP: How to Write a Research ...
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A-HeFT? Design and Study Population PowerPoint PPT Presentation
A-HeFT? Design and Study Population - Demonstrate the safety and efficacy of BiDil compared ... 1 tab tid. 2 tabs tid. 3. mo. 3. QoL. 6. mo. 4. 9. mo. 5. 12. mo. 6. 15. mo. 7. 18. mo. 8 (final) ...
Demonstrate the safety and efficacy of BiDil compared ... 1 tab tid. 2 tabs tid. 3. mo. 3. QoL. 6. mo. 4. 9. mo. 5. 12. mo. 6. 15. mo. 7. 18. mo. 8 (final) ...
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CV disease: US prevalence. American Heart Association. .. PowerPoint PPT Presentation
CV disease: US prevalence. American Heart Association. .. - CV disease: US prevalence. American Heart Association. ... Heart failure (reversible ischemia vs scar) Peripheral arterial disease ...
CV disease: US prevalence. American Heart Association. ... Heart failure (reversible ischemia vs scar) Peripheral arterial disease ...
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