Clinical Research Milestones

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Clinical research milestones: Prior to award, investigators conducting clinical studies or clinical trials will be required to provide detailed interim performance measures and timelines for completing key objectives and administrative functions for the proposed clinical study or trial, as applicable. Milestones should be easily measurable and realistic. Milestones may include, as applicable, but are not limited to: • Finalization of the clinical study/trial protocol(s) and informed consent/assent forms (with NIDDK program official agreement, if applicable) and IRB approval • Registration of the clinical trial(s) in ClinicalTrials.gov • Completion of all required regulatory approvals (e.g., Investigational New Drug Application from the Food and Drug Administration) • Contracts/third party agreements, including intervention product supply • Good Clinical Practice (GCP) and other relevant technical training of study staff • Anticipated date of enrollment of the first participant • Recruitment and/or randomization of 25%, 50%, 75% and 100% of the target sample size • Follow-up visit completion, if applicable, of 25%, 50%, 75% and 100% of the enrolled or randomized study population, including women, minorities and children • Completion of data collection • Completion of primary endpoint and secondary endpoint data analyses • Completion of final study report and manuscript submission • Closeout plans/communication of results to participants • Reporting of results in ClinicalTrials.gov. These milestones will be negotiated at the time of the award, as appropriate. Future year support is contingent on satisfactory achievement of performance milestones. If milestones are not achieved fully, NIDDK may request development of a remedial plan and more frequent monitoring of progress, or take other remedial actions. .

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Certification Accredited Schools List
= Academic Clinical Research Programs Which Currently Meet Waiver Requirements for the Academy of Clinical Research Professional (Updated October 15, 2015) This list includes academic clinical research programs which, as of the above date, have been evaluated and found to meet the current waiver requirements established by the Academy of Clinical Research Professionals (Academy) Board of Trustees. Programs that meet the waiver requirements allow a candidate to waive 1,500 hours of hands-on experience performing the Essential Duties of the program to which the candidate has made application. This list is not to be considered exhaustive and is not designed to represent all the academic offerings available. Appearance on this list is not to be construed as an endorsement of its content or format by the Academy or a guarantee that a candidate will be eligible for certification. All individuals interested in enrolling in a program of study should evaluate any program on the basis of his or her personal needs. (* - programs marked with an asterisk MAY be accepted but acceptance will be dependent on the complete listing of courses completed) Individuals seeking additional information about each program should contact the institution directly. Academic Institution Program Name ( Click Title for Web Navigation) Academy of Applied Pharmaceutical Sciences Clinical Research Diploma Program American University of Health Sciences Master of Science in Clinical Research Anoka-Ramsey Community College Clinical Research Professional - Certificate Graduate
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Placebo-Controlled Trials of New Drugs: Ethical Considerations
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Generating Real-World Evidence by Strengthening Real-World Data Sources
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Studies of Staphylococcal Infections. I. Virulence of Staphy- Lococci and Characteristics of Infections in Embryonated Eggs * WILLIAM R
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Using Real-World Evidence to Accelerate Safe and Effective Cures Advancing Medical Innovation for a Healthier America June 2016 Leadership Senator William H
Using Real-World Evidence to Accelerate Safe and Effective Cures Advancing Medical Innovation for a Healthier America June 2016 Leadership Senator William H. Frist, MD Former U.S. Senate Majority Leader Chair, FDA: Advancing Medical Innovation Bipartisan Policy Center Representative Bart Gordon Former Member, U.S. House of Representatives Chair, FDA: Advancing Medical Innovation Bipartisan Policy Center Advisory Committee Marc M. Boutin, JD Chief Executive Officer National Health Council Mark McClellan, MD, PhD Director, Robert J. Margolis Center for Health Policy Duke University Patrick Soon-Shiong, MD Chairman and Chief Executive Officer Institute for Advanced Health Andrew von Eschenbach, MD President Samaritan Health Initiatives 1 Sta G. William Hoagland Ann Gordon Senior Vice President Writer Bipartisan Policy Center Michael Ibara, PharmD Janet M. Marchibroda Independent Consultant Director, Health Innovation Initiative and Executive Director, CEO Council on Health and Innovation Bipartisan Policy Center Tim Swope Senior Policy Analyst Bipartisan Policy Center Sam Watters Administrative Assistant Bipartisan Policy Center 2 FDA: ADVANCING MEDICAL INNOVATION EFFORT The Bipartisan Policy Center’s initiative, FDA: Advancing Medical Innovation, is developing viable policy options to advance medical innovation and reduce the time and cost associated with the discovery, development, and delivery of safe and effective drugs and devices for patients in the United States. Key areas of focus include the following: Improving the medical product development process; Increasing regulatory clarity; Strengthening the Food and Drug Administration’s (FDA) ability to carry out its mission; Using information technology to improve health and health care; and Increasing investment in medical products to address unmet and public health needs.
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Short List of Commonly Used Acronyms in Clinical Research
Short List of Commonly Used Acronyms in Clinical Research ACRP Association of Clinical Research Professionals AE Adverse Event ADR Adverse Drug Reaction AMA American Medical Association BAA Business Associate Agreement BIND Biological IND CA Coverage Analysis CAP College of American Pathologists CBCTN Community Based Clinical Trials Network CCRA Certified Clinical Research Associate (ACRP) CCRC Certified Clinical Research Coordinator (ACRP) CCRT Center for Clinical Research & Technology CCRP Certified Clinical Research Professional (SoCRA) CDA Confidential Disclosure Agreement CDC Center for Disease Control CFR Code of Federal Regulations CIRBI Center for IRB Intelligence CITI Collaborative Institutional Training Initiative CLIA Clinical Laboratory Improvement Amendments CME Continuing Medical Education CMS Central Management System COI Conflict of Interest CRA Clinical Research Associate CRC Clinical Research Coordinator CREC Continuing Research Education Credit CRF Case Report Form CRO Clinical Research Organization CTA Clinical Trial Agreement CTSC Clinical & Translational Science Collaborative CV Curriculum Vitae DCF Data Correction Form / Data Clarification Form DEA Drug Enforcement Agency (law enforcement division of FDA) DHHS Department of Health and Human Services DOS Date of Service DSMB or Data and Safety Monitoring Board (Plan or Committee) DSMP/C EAB Ethical Advisory Board (similar to IRB, used by other nations) EDC Electronic Data Capture FDA Food and Drug Administration FDA-482 Notice of Inspection FDA-483 Notice of Adverse
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A Framework to Assess Empirical Reproducibility in Biomedical Research Leslie D
McIntosh et al. BMC Medical Research Methodology (2017) 17:143 DOI 10.1186/s12874-017-0377-6 RESEARCH ARTICLE Open Access Repeat: a framework to assess empirical reproducibility in biomedical research Leslie D. McIntosh1, Anthony Juehne1*, Cynthia R. H. Vitale2, Xiaoyan Liu1, Rosalia Alcoser1, J. Christian Lukas1 and Bradley Evanoff3 Abstract Background: The reproducibility of research is essential to rigorous science, yet significant concerns of the reliability and verifiability of biomedical research have been recently highlighted. Ongoing efforts across several domains of science and policy are working to clarify the fundamental characteristics of reproducibility and to enhance the transparency and accessibility of research. Methods: The aim of the proceeding work is to develop an assessment tool operationalizing key concepts of research transparency in the biomedical domain, specifically for secondary biomedical data research using electronic health record data. The tool (RepeAT) was developed through a multi-phase process that involved coding and extracting recommendations and practices for improving reproducibility from publications and reports across the biomedical and statistical sciences, field testing the instrument, and refining variables. Results: RepeAT includes 119 unique variables grouped into five categories (research design and aim, database and data collection methods, data mining and data cleaning, data analysis, data sharing and documentation). Preliminary results in manually processing 40 scientific manuscripts indicate components of the proposed framework with strong inter-rater reliability, as well as directions for further research and refinement of RepeAT. Conclusions: The use of RepeAT may allow the biomedical community to have a better understanding of the current practices of research transparency and accessibility among principal investigators.
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Independent Data and Safety Oversigh for DMID Clinical Research
Policy No.: National Institute of Allergy and DMID Policy-010 - NCRS 1.2 v 2.0 Infectious Diseases / Division of Independent Data and Safety Oversight Microbiology and Infectious for DMID Clinical Research Diseases/Office of Clinical Research Affairs Effective Date: 13-JUL-2016 Version: 2.0 1.0 Purpose: To describe the Division of Microbiology and Infectious Diseases (DMID) policy for establishing independent data and safety oversight for DMID-supported clinical research. 2.0 Scope: This policy applies to DMID-supported clinical research studies where there are concerns about participant safety or data integrity. These types of studies require independent safety assessment. 3.0 Policy: An appropriate safety oversight plan will be described in the protocol. If applicable, an appropriate independent safety charter for all clinical research commensurate with risks, the size, and complexity of the study will be prepared. This plan will provide a description of the review of safety and/or efficacy data to assess volunteer safety and data integrity. The plan will state the level of independent oversight necessary or that no independent oversight is required. For grant-funded clinical research that does not require a formal protocol, the awarded grant will serve as the document describing the appropriate level of oversight. 4.0 Background: NIH policy requires that each Institute and Center (IC) have a system for managing/implementing the appropriate oversight of the conduct of clinical trials that ensures the safety of participants and the validity and integrity of the data. DMID extends this requirement to other clinical research where there are safety concerns. Data and safety oversight provides independent and objective review of the overall conduct of the study.
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Good Practices for Real‐World Data Studies of Treatment And/Or
VALUE IN HEALTH 20 (2017) 1003– 1008 Available online at www.sciencedirect.com journal homepage: www.elsevier.com/locate/jval Original Report Good Practices for Real‐World Data Studies of Treatment and/or Comparative Effectiveness: Recommendations from the Joint ISPOR‐ISPE Special Task Force on Real‐World Evidence in Health Care Decision Making Ã Marc L. Berger1, , Harold Sox2, Richard J. Willke3, Diana L. Brixner4, Hans‐Georg Eichler5, Wim Goettsch6, David Madigan7, Amr Makady6, Sebastian Schneeweiss8, Rosanna Tarricone9, Shirley V. Wang8, John Watkins10, C. Daniel Mullins11 1New York City, NY, USA; 2Patient-Centered Outcomes Research Institute, Washington, DC, USA; 3International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville, NJ, USA; 4University of Utah, Salt Lake City, UT, USA; 5European Medicines Agency, London, UK; 6Zorginstituut Nederland and University of Utrecht, Utrecht, The Netherlands; 7Columbia University, New York City, NY, USA; 8Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; 9Bocconi University, Milan, Italy; 10Premera Blue Cross, Mountlake Terrace, WA, USA; 11University of Maryland, Baltimore, MD, USA ABSTRACT Purpose: Real‐world evidence (RWE) includes data from retrospective involvement in RWE studies. These recommendations, in concert with or prospective observational studies and observational registries and earlier recommendations about study methodology, provide a trust- provides insights beyond those addressed by randomized controlled worthy foundation for the expanded use of RWE in health care decision trials. RWE studies aim to improve health care decision making. making. Conclusion: The focus of these recommendations is good Methods: The International Society for Pharmacoeconomics and Out- procedural practices for studies that test a speciﬁchypothesisina comes Research (ISPOR) and the International Society for Pharmacoepi- speciﬁc population.
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Module Catalogue Clinical Research and Epidemiology
Module Catalogue for the Subject Clinical Research and Epidemiology as a Master’s with 1 major with the degree "Master of Science" (90 ECTS credits) Examination regulations version: 2015 Responsible: Faculty of Medicine JMU Würzburg • generated 23-Aug-2021 • exam. reg. data record 88|g73|-|-|H|2015 Module Catalogue for the Subject Clinical Research and Epidemiology Master’s with 1 major, 90 ECTS credits Contents The subject is divided into 3 Content and Objectives of the Programme 4 Abbreviations used, Conventions, Notes, In accordance with 5 Compulsory Courses 6 Compulsory Courses I: Basics of Epidemiology and Biometry 7 Introduction into epidemiology and biometry 8 Biometrical methods 9 Applied biometry 10 Epidemiological methods and evidence-based medicine 11 Compulsory Courses II: Clinical and Epidemiological Research 12 Topical clinical research questions and interpretation of clinical trials 13 Disease-specific epidemiology and prognostic modelling 14 Research methodology (I: Clinical trial methodology, II: Transferable skills training) 15 Compulsory Courses III: Research Placement 16 Practical training I 17 Practical training II 18 Thesis 19 Master Thesis Clinical Research and Epidemiology 20 Colloquium Master Thesis 21 Master’s with 1 major Clinical Research and Epide- JMU Würzburg • generated 23-Aug-2021 • exam. reg. data record page 2 / 21 miology (2015) Master (90 ECTS) Klinische Forschung und Epidemiologie - 2015 Module Catalogue for the Subject Clinical Research and Epidemiology Master’s with 1 major, 90 ECTS credits The subject is divided into starting section / sub-section ECTS credits page Compulsory Courses 60 6 Compulsory Courses I: Basics of Epidemiology and Biometry 22 7 Compulsory Courses II: Clinical and Epidemiological Research 18 12 Compulsory Courses III: Research Placement 20 16 Thesis 30 19 Master’s with 1 major Clinical Research and Epide- JMU Würzburg • generated 23-Aug-2021 • exam.
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NIAID's Antibiotic Resistance Research Framework: Current Status and Future Directions
NIAID’S Antibiotic Resistance Research Framework: NIAID Current Status and Future Directions 2019 NIAID's Antibiotic Resistance Research Framework: Current Status and Future Directions Table of Contents Executive Summary ............................................................................................................................ 1 Introduction ......................................................................................................................................... 2 The Evolution and Accelerating Pace of Antibiotic Resistance (AR) ................................................2 The Antibiotic Development Pipeline ................................................................................................. 3 NIAID: Stimulating Research on AR .................................................................................................. 3 Basic Research................................................................................................................................. 3 Translational Research .................................................................................................................... 4 Clinical Research............................................................................................................................. 6 Research Resources ......................................................................................................................... 8 Partnerships Facilitate a Concerted Approach ...................................................................................
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Reproducibility of Clinical Research in Critical Care: a Scoping Review Daniel J
Niven et al. BMC Medicine (2018) 16:26 https://doi.org/10.1186/s12916-018-1018-6 RESEARCH ARTICLE Open Access Reproducibility of clinical research in critical care: a scoping review Daniel J. Niven1*, T. Jared McCormick2, Sharon E. Straus3, Brenda R. Hemmelgarn4, Lianne Jeffs5, Tavish R. M. Barnes1 and Henry T. Stelfox1 Abstract Background: The ability to reproduce experiments is a defining principle of science. Reproducibility of clinical research has received relatively little scientific attention. However, it is important as it may inform clinical practice, research agendas, and the design of future studies. Methods: We used scoping review methods to examine reproducibility within a cohort of randomized trials examining clinical critical care research and published in the top general medical and critical care journals. To identify relevant clinical practices, we searched the New England Journal of Medicine, The Lancet, and JAMA for randomized trials published up to April 2016. To identify a comprehensive set of studies for these practices, included articles informed secondary searches within other high-impact medical and specialty journals. We included late-phase randomized controlled trials examining therapeutic clinical practices in adults admitted to general medical-surgical or specialty intensive care units (ICUs). Included articles were classified using a reproducibility framework. An original study was the first to evaluate a clinical practice. A reproduction attempt re-evaluated that practice in a new set of participants. Results: Overall, 158 practices were examined in 275 included articles. A reproduction attempt was identified for 66 practices (42%, 95% CI 33–50%). Original studies reported larger effectsthanreproductionattempts(primary endpoint, risk difference 16.0%, 95% CI 11.6–20.5% vs.
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