Regulatory Knowledge Support: What’s Next?

•Transferir como PPTX, PDF•

2 gostaram•669 visualizações

CTSI at UCSF

Saúde e medicina Tecnologia

Regulatory Knowledge Support: What next? Bernard Lo, M.D., Deborah Grady, M.D., Peter St. Wecker, Ph.D. July 28, 2011

Things we’ve done RKS consultations Marlene Berro Contracts and Grants Erik Lium IRB electronic submissions John Heldens

Things we’re still doing Multi-site IRB review Alan Venook John Heldens Lisa Denny

Things we’d like to do Revamp regulatory training Responsible conduct of research online CHR training on line?

Things we’d like to do Process mapping for research Identify steps in research process Remove those that don’t add value Aim for simultaneous (parallel) processes Human Relations?

Things we’d like to do Proposed revisions to regulations for human subjects research One IRB reviews multisite studies Minimal risk research excused from IRB review Improving consent process Simplify, shorten consent forms Assess comprehension of participant

Things we’d like to do Proposed revisions to regulations for human subjects research Consent for biospecimens for future research Data security standards

ANPRM poses 70 questions:How can CTSI help? Open forum Responses from UCOP CTSI national program Professional societies Community partners

Regulatory Knowledge Support: What’s Next?

Mais conteúdo relacionado

Destaque

UCSF Informatics Day 2014 - Sayan Chatterjee, "APeX Reporting"

CTSI at UCSF

UCSF Informatics Day 2014 - Sam Hawgood, "Informatics at UCSF"

CTSI at UCSF

Best Practices in Clinical Study Recruitment

CTSI at UCSF

More Than the Sum of its Parts – Leveraging a UC Network

CTSI at UCSF

UCSF Informatics Day 2014 - Michael Blum, "Digital Health"

CTSI at UCSF

Amia 2011: Using OpenSocial to Leverage a Community of Developers

CTSI at UCSF

A Writer's Algorithm: Papers without (too much) Pain

CTSI at UCSF

A Clinical Trial of CCR5 Inhibition in Treated HIV Infection: Highlighting Mu...

CTSI at UCSF

Open Proposals: Pre-competitive Space for Research Community

CTSI at UCSF

Early Translational Research at UCSF-CTSI: Programs, Plans and Partners

CTSI at UCSF

Mary Whooley. MD: Tips for the PCORI Application Process

CTSI at UCSF

Destaque (11)

UCSF Informatics Day 2014 - Sayan Chatterjee, "APeX Reporting"

UCSF Informatics Day 2014 - Sam Hawgood, "Informatics at UCSF"

Best Practices in Clinical Study Recruitment

More Than the Sum of its Parts – Leveraging a UC Network

UCSF Informatics Day 2014 - Michael Blum, "Digital Health"

Amia 2011: Using OpenSocial to Leverage a Community of Developers

A Writer's Algorithm: Papers without (too much) Pain

A Clinical Trial of CCR5 Inhibition in Treated HIV Infection: Highlighting Mu...

Open Proposals: Pre-competitive Space for Research Community

Early Translational Research at UCSF-CTSI: Programs, Plans and Partners

Mary Whooley. MD: Tips for the PCORI Application Process

Semelhante a Regulatory Knowledge Support: What’s Next?

Slides from NHS Citizen Research Workshop convened on the 7th of April 2015 at the University of Westminster to discuss the Research Hub, a brand new element of the NHS Citizen design intended to support wider research and knowledge sharing. The aim of the workshop was to explore possible research questions and projects and this presentation explores possible tools, methods and processes that might be employed in research around NHS Citizen

Nhs citizen research workshop tools, methods & process

NHSCitizen

Chaunceywilson

zmiers

Compliant Dissemination of Promotional and Educational Material

Good Promotional Practices

Real-Life Compliance Solutions: Part I

Prolifiq Software

Chapter 17 Intervention Interventions Broadly defined, the intervention or treatment is any change, addition or subtraction, from care being given or from the environment of the participant 2 Interventions Three dimensions of interventions are: Intensity of care Focus of care Complexity of care 3 Examples of Interventions Educational Self-care Lifestyle changes Population-level Naturally occurring events Biofeedback Animal models Over-the-counter medications, herbals, and supplements 4 Examples of Interventions Physical care Psychotherapeutic Care management and coordination Transitional care Multicomponent Administrative and managerial changes in care process Alternative and complementary interventions 5 Multicomponent Interventions Several interventions provided simultaneously Capitalizes on potential for synergy Difficult to know which aspect(s) had an effect 6 Selecting Interventionists Look for the following characteristics in people who will be implementing the intervention: Knowledge and skill related to the intervention Dependability Good judgment Objectivity 7 Training Interventionists Training should cover: Purpose of study Background information Importance of maintaining protocol Human subjects considerations The intervention protocol Study design 8 Training Interventionists Training should cover: Rationale An outline of the treatment(s) that will be given Fill in the details needed to actually carry out the intervention Approach to participant Relationship to staff 9 Training Interventionists Training should cover: Recording responses to treatment Expectations of interventionists Authorship Communication with other team members and investigators 10 Working with Facility Staff Permission may be required Staff should be fully informed about the purpose of the study Staff roles in the study need to be explained Staff may need to be trained 11 Working with Facility Staff Be respectful of staff time and regular responsibilities Agree upon patient participation documentation Utilize staff knowledge of participants 12 Implementation Monitor adherence to protocol Monitor participant safety If the study is complex and poses a higher level of risk, a data safety monitoring board (DSMB) is needed 13 Implementation Serious adverse events (SAEs) are expected to be reported immediately to the DSMB and the IRB and may include: Death Life-threatening event Hospitalization Disability Congenital anomaly Treatment is required to prevent permanent damage 14 Implementation The IRB usually requires a written plan for data and safety monitoring and may include: Level of risk to participant Plan for monitoring Frequency and specifics of data reviews and reports To whom the results of the reviews will be submitted to 15 Chapter 16 Internet, Secondary Analysis, and Historical Research Uses of the Internet in Research Search capabilities provide access to resources Participants can ...

Chapter 17InterventionInterventionsBroadly defined, th.docx

keturahhazelhurst

Legal Informatics Research Today: Implications for Legal Prediction, 3D Print...

Robert Richards

Agnes Dede: Bureaucratic processes and the IT

Informatikai Intézet

The new guidelines for specialist report writers in the family court. Suzi Bl...

NZ Psychological Society

Pervasive information streams that document people and their routines have been a boon to social computing research. But the ethics of collecting and analyzing available—but potentially sensitive—online data present challenges to researchers. In response to increasing public and scholarly debate over the ethics of online data research, this paper analyzes the current state of practice among researchers using online data. Qualitative and quantitative responses from a survey of 263 online data researchers document beliefs and practices around which social computing researchers are converging, as well as areas of ongoing disagreement. The survey also reveals that these disagreements are not correlated with disciplinary, methodological, or workplace affiliations. The paper concludes by reflecting on changing ethical practices in the digital age, and discusses a set of emergent best practices for ethical social computing research.

CSCW 2016: Beyond the Belmont Principles

Jessica Vitak

Legal education and training review presentation 010711 (no notes)

LETRteam

Review of Communications in DFID-funded Research Programme Consortia (RPCs)

ODI_Webmaster

Visualization for public policy (2016)

Arthi Krishnaswami

What is e-research? Enhancing research practice e-Research Methods, Strategies, and Issues Tips For Finding Useful Information Some Search Tools for doing e-research Research Design Quantitative Research Qualitative Research Ethics & The e-Researcher How The Net Complicates Ethics? Privacy, Confidentiality, Autonomy, And The Respect For Persons Tips For Ethical e-Research Collaboration Tools Why Consensus? Net-based dissemination of E-research results Dissemination through peer-reviewed articles Advantages of a peer-reviewed article Dissemination through email lists or Usenet groups Dissemination through a virtual conference

Concept on e-Research

Md. Nazrul Islam

Articulation

butest

Evidence Briefings: Towards a Medium to Transfer Knowledge from Systematic Re...

UFPA

Justice Reform Programme in England and Wales by Hazel Genn, OECD Global Poli...

OECD Governance

COUR CJUS 750Coding Assignment Instructions Return to the “Developing Research Questions” assignment from Module/Week 3. With interview transcripts in hand, create a code book for interviews. Begin in small groups, look at the ways people coded their respective interviews. See if there is agreement on major and minor codes. Discuss the different kinds of stories each coding scheme might tell. Cut and sort by major and minor codes looking for patterns, relationships, further categorizations. Make note of analytical findings. Hold onto these clumps of coded data for a future exercise. Assignment Specifics: · Student will write 3-5 page paper · Citations from any of the required reading/presentations from the assigned module · APA format This assignment is due on Sunday evening at 11:59 pm EST of Module 6 Page 1 of 2 Page 1 of 1 Running head: EVIDENCE BASED POLICING APPROACH 1 EVIDENCE BASED POLICING APPROACH 4 Shanee’ N. Ellington Liberty University Evidence Based Policing Approach Professor Richards 28 Jan 20 Problem Statement In the previous years, investigations regarding criminal justice have been faced by a lot of irregularities. There has been a lot of corruption and violation of procedures. This has made people who were not guilty of crime to be taken as guilty due to being fixed (Laycock, 2012). Thus, this necessitated the need to come up with an evidence based approach to help in law enforcement. Research Statement This research is about evidenced based approach which is the use of scientific processes when making decisions regarding criminal justice cases. The research will look at the components that help to come up strategies of ensuring criminal justice. They include increasing the amount of research and transforming research findings into a format that a police officer can understand easily (Laycock, 2012). Some of the activities that police engage in that improve evidence based approach will be focused on. The research will also look at the activities that undermine evidence based approach. Violation of procedures and corruption hinder evidence based approach. On the other hand, following the right procedures in investigations and avoiding corruption helps to improve evidence based approach. The challenges faced in the process of achieving evidence based approval are also addressed. They include inadequacy of documents required for crime analysis and peer pressure since some junior officers may do something that seniors do not approve (Sherman, 2013). Also, evidence based approach limits police officers from getting out of the car to conduct patrols. Additionally in police academies, there is overemphasis on following of procedures instead of dealing with the evidence at hand Research and Interview Questions Research Questions 1. What are the components that are used to come up with strategies of carrying out an evidence-based policing approach? 2. What are the changes that are faced in the process of cond.

COUR CJUS 750Coding Assignment InstructionsReturn to the .docx

mercylittle80626

SOC2002 Lecture 4

Bonnie Green

Borgman orcid dryadsymposiumoxford20130523

ORCID, Inc

Presentation at #CALT2015, Ottawa

Julian Webb

Semelhante a Regulatory Knowledge Support: What’s Next? (20)

Nhs citizen research workshop tools, methods & process

Chaunceywilson

Compliant Dissemination of Promotional and Educational Material

Real-Life Compliance Solutions: Part I

Chapter 17InterventionInterventionsBroadly defined, th.docx

Legal Informatics Research Today: Implications for Legal Prediction, 3D Print...

Agnes Dede: Bureaucratic processes and the IT

The new guidelines for specialist report writers in the family court. Suzi Bl...

CSCW 2016: Beyond the Belmont Principles

Legal education and training review presentation 010711 (no notes)

Review of Communications in DFID-funded Research Programme Consortia (RPCs)

Visualization for public policy (2016)

Concept on e-Research

Articulation

Evidence Briefings: Towards a Medium to Transfer Knowledge from Systematic Re...

Justice Reform Programme in England and Wales by Hazel Genn, OECD Global Poli...

COUR CJUS 750Coding Assignment InstructionsReturn to the .docx

SOC2002 Lecture 4

Borgman orcid dryadsymposiumoxford20130523

Presentation at #CALT2015, Ottawa

Mais de CTSI at UCSF

AMIA Joint Summits 2017: Building Research Data Mart from UCSF OMOP Database ...

CTSI at UCSF

CER 2016 Trontell pcori cer presentation 2016 02 02 final

CTSI at UCSF

CER 2016 Srivastava

CTSI at UCSF

CER 2016 Phillips cer symposium pcori 2016 from 012716

CTSI at UCSF

CER 2016 Nguyen ctsi collaborative research

CTSI at UCSF

CER 2016 Hernandez patient engagement

CTSI at UCSF

CER 2016 Dohan EQUIP

CTSI at UCSF

CER 2016 Jacoby stakeholder engagement

CTSI at UCSF

CER 2016 Goldman CTSI CER Resources

CTSI at UCSF

CER 2016 Goldman Intro

CTSI at UCSF

On Sep 17th Catalyst brought a panel of academic and industry thought leaders for a lively discussion on the issue of data reproducibility in academic research. Moderated by Cathy Tralau-Stewart, head of the Therapeutics track of the Catalyst Awards, the panel explored causes and potential solutions for a problem that has been receiving national attention in both scientific and popular media. Panelists included Keith Yamamoto, Vice Chancellor for Research at UCSF; Larry Tabak, Principle Deputy Director, NIH; John Ioannidis, Professor of Health Research Policy at Stanford School of Medicine; Elizabeth Iorns, Co-Founder, Science Exchange; Parker B. Antin, Board of Directors President, FASEB; Amanda Halford, MBA, VP of Research, Sigma-Aldrich. http://ctsi.ucsf.edu/news/about-ctsi/data-reproducibility-preclinical-research-and-discovery

Data Reproducibility in Preclinical Discovery, Is It a Real Problem? 09/17/15

CTSI at UCSF

Building Your Professional Network with LinkedIn

CTSI at UCSF

How to Harness the Power of Google Analytics, Email Marketing & Vanity to Inc...

CTSI at UCSF

Poster presented at VIVO 2014 conference: Utilized UCSF Profiles web analytics data to deliver a customized “UCSF Profiles Annual Report” to individual researchers at UCSF, which listed their total annual unique pageviews, broken down by major relevant categories (e.g. pageviews from the UCSF campus, NIH, pharmaceutical companies, foundations, and other universities). Result: Increase in user engagement and edite Profiles pages. UCSF-CTSI Team: Nooshin Latour, MA, Sr. Communications & Marketing Manager and Anirvan Chatterjee, Director of Data Strategy

VIVO 2014: Google Analytics, Email Marketing & Vanity to Increase User Engage...

CTSI at UCSF

UCSF Informatics Day 2014 - Ida Sim, "Informatics Technologies: From a Data-C...

CTSI at UCSF

UCSF Informatics Day 2014 - Keith R. Yamamoto, "Precision Medicine"

CTSI at UCSF

UCSF Informatics Day 2014 - Lindsey Watt Alami, "Study Management throughout ...

CTSI at UCSF

UCSF Informatics Day 2014 - Elizabeth St. Lezin, "Blood Transfusion Research ...

CTSI at UCSF

UCSF Informatics Day 2014 - Dana Ludwig, "Research Data Browser"

CTSI at UCSF

UCSF Informatics Day 2014 - Robert Nussbaum, "The Genomic Medicine Initiative...

CTSI at UCSF

Mais de CTSI at UCSF (20)