The Health Research Authority (HRA) was established in 2011 to simplify the process for approval of health research in the NHS in England. The HRA aims to reduce the time and cost of setting up studies through a single application process called HRA Approval. When fully implemented, HRA Approval will provide assurance to NHS organizations in England that a study can be undertaken, replacing other approval processes. The presentation provides updates on the phased implementation of HRA Approval for different study types.
This document describes the SPACER study which aims to identify the benefits and disadvantages of electronic prescribing and medication administration (EPMA) compared to paper-based systems. The SPACER study will consist of 3 strands conducted over 3 years: 1) An ethnographic study to observe organizational changes and staff perspectives with EPMA implementation. 2) A data envelopment analysis study to assess the impact of EPMA on healthcare service efficiency. 3) A Drugs, Data, Decisions study to identify changes to key performance measures, processes, reporting and decision making regarding the medication process before, during and after EPMA implementation.
The document summarizes the history of healthcare development in Birmingham over the past century, from the origins of early hospitals to the planning and construction of the new Queen Elizabeth Hospital. It describes:
- The early voluntary and municipal hospitals established in Birmingham from the 18th century to treat the poor.
- The social, medical, and technological changes in the early 20th century that increased demand for hospital services.
- The controversies over proposals in the 1920s-30s to build a new united hospital center to replace overcrowded facilities.
- The planning process that ultimately led to the construction of the original Queen Elizabeth Hospital, which opened in 1938.
- The need for renewal that resulted in
Reporting Guidelines
Society for Clinical Trials Conference; Arlington, Virginia
May 17th 2015
This presentation was part of the workshop organised by Karla Hemming: Research and reporting methods for the stepped wedge cluster randomised controlled trial
it is a business plan for left handed shop let me know how it was there is some technical problem in this slide I don't know why but hope you understand
Three treatment arms: Stepped wedge like and other designs
Steven Teerens
Society for Clinical Trials Conference; Arlington, Virginia
May 17th 2015
This presentation was part of the workshop organised by Karla Hemming: Research and reporting methods for the stepped wedge cluster randomised controlled trial
Russell Mannion's critique on Dr Yen-Fu Chen's presentation on publication bias in service delivery research for the CLAHRC WM Scientific Advisory Group, 10th June 2015, Birmingham, UK
This document describes the SPACER study which aims to identify the benefits and disadvantages of electronic prescribing and medication administration (EPMA) compared to paper-based systems. The SPACER study will consist of 3 strands conducted over 3 years: 1) An ethnographic study to observe organizational changes and staff perspectives with EPMA implementation. 2) A data envelopment analysis study to assess the impact of EPMA on healthcare service efficiency. 3) A Drugs, Data, Decisions study to identify changes to key performance measures, processes, reporting and decision making regarding the medication process before, during and after EPMA implementation.
The document summarizes the history of healthcare development in Birmingham over the past century, from the origins of early hospitals to the planning and construction of the new Queen Elizabeth Hospital. It describes:
- The early voluntary and municipal hospitals established in Birmingham from the 18th century to treat the poor.
- The social, medical, and technological changes in the early 20th century that increased demand for hospital services.
- The controversies over proposals in the 1920s-30s to build a new united hospital center to replace overcrowded facilities.
- The planning process that ultimately led to the construction of the original Queen Elizabeth Hospital, which opened in 1938.
- The need for renewal that resulted in
Reporting Guidelines
Society for Clinical Trials Conference; Arlington, Virginia
May 17th 2015
This presentation was part of the workshop organised by Karla Hemming: Research and reporting methods for the stepped wedge cluster randomised controlled trial
it is a business plan for left handed shop let me know how it was there is some technical problem in this slide I don't know why but hope you understand
Three treatment arms: Stepped wedge like and other designs
Steven Teerens
Society for Clinical Trials Conference; Arlington, Virginia
May 17th 2015
This presentation was part of the workshop organised by Karla Hemming: Research and reporting methods for the stepped wedge cluster randomised controlled trial
Russell Mannion's critique on Dr Yen-Fu Chen's presentation on publication bias in service delivery research for the CLAHRC WM Scientific Advisory Group, 10th June 2015, Birmingham, UK
The document summarizes updates from the Health Research Authority (HRA) board meeting in October 2017. Key points include: more valid applications being received for commercial clinical trials due to training and checklist changes; continued evaluation of the joined-up validation model; and meetings held to review the 70-day benchmark for HRA approval. Work is also underway on model commercial and non-commercial clinical trial agreements and improving guidance on IRAS and the new website. Planning is occurring for implementation of the new EU General Data Protection Regulation and incorporating more public involvement.
Global grants support large international activities with sustainable, measurable outcomes in Rotary’s areas of focus. Hear an overview of global grants and the importance of Rotarian involvement in monitoring and evaluation. Learn about scholarships and how you can sponsor or host global grant scholars. By the end of the session you’ll understand the components of a quality project and be prepared to start your global grant application.
Global grants support large international activities with
sustainable, measurable outcomes in Rotary’s areas of focus.
Hear an overview of global grants and the importance of
Rotarian involvement in monitoring and evaluation. Learn
about scholarships and how you can sponsor or host global
grant scholars. By the end of the session you’ll understand
the components of a quality project and be prepared to start
your global grant application.
The document discusses the RCUK's open access policy, including its definition of open access, expectations for researchers and journals, implementation of the policy, and plans for a 2014 review. Some key points:
- The policy requires open access to peer-reviewed research articles acknowledging RCUK funding by April 2013, allowing a transitional period for compliance.
- "Gold" open access means publishing in open access journals with a CC-BY license, while "Green" allows depositing the final manuscript in a repository with limited embargoes.
- The 2014 review will evaluate the policy's impact and compliance based on evidence submitted. Compliance monitoring will analyze open access rates by institution and research council.
The Rural Health Care program provides funding to support telecommunications services for rural health care providers. It is administered by the Universal Service Administrative Company on behalf of the Federal Communications Commission. There are two main funding programs - a Pilot Program that supports 85% of broadband network costs, and a Primary Program that provides discounts for telecom services and internet access. To be eligible, a provider must be located in a rural area, be non-profit or public, and be a type of health care organization defined by the program such as a hospital, clinic, or health department. Applicants complete a four-step process involving filing forms to request services, select bids, receive funding, and confirm services. The program is undergoing changes including
Guidance on the register of apprenticeship training providers (RoATP) 9 Nov ...City & Guilds
The second of our autumn webinars, will help you get to grips with how to submit your application to the RoATP.
In order to supply apprenticeships from May 2017, you’ll have to fulfil the requirements of the Register. With our help, you’ll be in the best possible position to successfully apply.
Please note that the information in this webinar is correct as of the date of airing on 9 November 2016.
The CMS Innovation Center held the second in a series of webinars on Wednesday, July 6, 2016 for the Support and Alignment Networks under the Transforming Clinical Practice Initiative (TCPI). This webinar focused on providing information regarding the application process.
- - -
CMS Innovation Center
http://innovation.cms.gov
We accept comments in the spirit of our comment policy:
http://newmedia.hhs.gov/standards/comment_policy.html
CMS Privacy Policy
http://cms.gov/About-CMS/Agency-Information/Aboutwebsite/Privacy-Policy.html
This document summarizes a workshop discussing proposals to improve the timeliness of pension and investment transfers between financial institutions in the UK. Key discussion points included clarifying the definition of a "step" in the transfer process, exemptions to the proposed 48-hour standard for completing each step, data needs to monitor industry performance, and implementation timeframes. The group aimed to draft an industry statement by end of 2017 outlining the scope, exemptions and timelines for adopting the 48-hour standard across different parts of the financial sector.
More than seventy members attended the CANQATE Annual General Meeting on October 6, 2016 at the Arthur Chung Convention Centre, Georgetown Guyana. Read the President's Report presented to members...
Transforming Accountancy, Insurance & Legal Services with AI & DataKTN
UK Research and Innovation will invest up to £12 million in innovation projects to support the application of artificial intelligence (AI) and data technologies. Projects should aim to transform the 3 target sectors:
Accountancy
Insurance
Legal services
Find out more: https://ktn-uk.co.uk/funding/transforming-accountancy-insurance-and-legal-services-with-ai-and-data-small-projects-strand
ONC Market R&D Pilot challenge Webinar finalhealth2dev
The Market R&D Pilot Challenge, brought to you by the Office of the National Coordinator for Health Information Technology (ONC), will help bridge technological gaps by bringing together health care organizations and innovative companies through $300,000 in pilot funding awards and facilitated matchmaking. This webinar provides more detail on the challenge and answers some common questions
Snowball Metrics as Standard Information Agreements - Anna Clements and Peter...CASRAI
Snowball Metrics aim to become the international standard that is endorsed by research-intensive universities so that they can build and monitor the most effective strategies. It is a “bottom-up”, or sector-led, initiative in which universities themselves agree a single method to calculate metrics about their own performance so that they can compare themselves against each other in an apples-to-apples way. This enables them to benchmark and understand their strengths and weaknesses to help to decide in which areas to invest, and in which to divest.
This Webinar will provide delegates with an overview of the Wellcome Trust and RCUK OA policies. It will discuss current levels of compliance, and key issues which need to be addressed if full OA is going to be realised. The Webinar will also discuss the recent study, led by the Wellcome Trust, which looked at what levers funders could pull to help encourage the development of an effective OA market for article processing charges.
NAAASP education and training update March 2016PHEScreening
Public Health England is introducing changes to the education and training for health screeners in the UK National Health Service. A new nationally-recognized Diploma for Health Screeners qualification is being developed, which will provide career progression opportunities for screening staff. The qualification involves 13 mandatory modules covering basic healthcare topics plus screening program-specific modules. Assessment will involve work-based competencies, online tests, assignments, and clinical assessments signed off by trainers. The reaccreditation process for screeners is also being strengthened, with knowledge assessments and scanning evaluations required every two years to maintain standards.
Open Access Progress and Promise in the CGIAR ConsortiumCIARD Movement
The presentation provided an overview and update on the CGIAR Consortium's progress in Open Access, including some of the challenges and opportunities of advocating for Open Access across the Consortium.
The webinar was presented by Piers Bocock, Director of Knowledge Management and Communication at the CGIAR Consortium. He is responsible for overseeing the development and implementation of the Consortium’s Knowledge Management, Communications, and IT strategies, leveraging best practices in these disciplines to help the Consortium deliver on its mandate.
The webinar provided an overview of the EPA Research Call 2022. It covered the introduction to EPA Research 2030 and its focus on achieving environmental objectives. It then discussed the details of the 2022 research call, including the two open topics, application process and timeline, eligibility criteria, and types of funding available. The presentation concluded with guidance on the application process and financial rules, and a Q&A session to address any questions.
The document summarizes updates from the Health Research Authority (HRA) board meeting in October 2017. Key points include: more valid applications being received for commercial clinical trials due to training and checklist changes; continued evaluation of the joined-up validation model; and meetings held to review the 70-day benchmark for HRA approval. Work is also underway on model commercial and non-commercial clinical trial agreements and improving guidance on IRAS and the new website. Planning is occurring for implementation of the new EU General Data Protection Regulation and incorporating more public involvement.
Global grants support large international activities with sustainable, measurable outcomes in Rotary’s areas of focus. Hear an overview of global grants and the importance of Rotarian involvement in monitoring and evaluation. Learn about scholarships and how you can sponsor or host global grant scholars. By the end of the session you’ll understand the components of a quality project and be prepared to start your global grant application.
Global grants support large international activities with
sustainable, measurable outcomes in Rotary’s areas of focus.
Hear an overview of global grants and the importance of
Rotarian involvement in monitoring and evaluation. Learn
about scholarships and how you can sponsor or host global
grant scholars. By the end of the session you’ll understand
the components of a quality project and be prepared to start
your global grant application.
The document discusses the RCUK's open access policy, including its definition of open access, expectations for researchers and journals, implementation of the policy, and plans for a 2014 review. Some key points:
- The policy requires open access to peer-reviewed research articles acknowledging RCUK funding by April 2013, allowing a transitional period for compliance.
- "Gold" open access means publishing in open access journals with a CC-BY license, while "Green" allows depositing the final manuscript in a repository with limited embargoes.
- The 2014 review will evaluate the policy's impact and compliance based on evidence submitted. Compliance monitoring will analyze open access rates by institution and research council.
The Rural Health Care program provides funding to support telecommunications services for rural health care providers. It is administered by the Universal Service Administrative Company on behalf of the Federal Communications Commission. There are two main funding programs - a Pilot Program that supports 85% of broadband network costs, and a Primary Program that provides discounts for telecom services and internet access. To be eligible, a provider must be located in a rural area, be non-profit or public, and be a type of health care organization defined by the program such as a hospital, clinic, or health department. Applicants complete a four-step process involving filing forms to request services, select bids, receive funding, and confirm services. The program is undergoing changes including
Guidance on the register of apprenticeship training providers (RoATP) 9 Nov ...City & Guilds
The second of our autumn webinars, will help you get to grips with how to submit your application to the RoATP.
In order to supply apprenticeships from May 2017, you’ll have to fulfil the requirements of the Register. With our help, you’ll be in the best possible position to successfully apply.
Please note that the information in this webinar is correct as of the date of airing on 9 November 2016.
The CMS Innovation Center held the second in a series of webinars on Wednesday, July 6, 2016 for the Support and Alignment Networks under the Transforming Clinical Practice Initiative (TCPI). This webinar focused on providing information regarding the application process.
- - -
CMS Innovation Center
http://innovation.cms.gov
We accept comments in the spirit of our comment policy:
http://newmedia.hhs.gov/standards/comment_policy.html
CMS Privacy Policy
http://cms.gov/About-CMS/Agency-Information/Aboutwebsite/Privacy-Policy.html
This document summarizes a workshop discussing proposals to improve the timeliness of pension and investment transfers between financial institutions in the UK. Key discussion points included clarifying the definition of a "step" in the transfer process, exemptions to the proposed 48-hour standard for completing each step, data needs to monitor industry performance, and implementation timeframes. The group aimed to draft an industry statement by end of 2017 outlining the scope, exemptions and timelines for adopting the 48-hour standard across different parts of the financial sector.
More than seventy members attended the CANQATE Annual General Meeting on October 6, 2016 at the Arthur Chung Convention Centre, Georgetown Guyana. Read the President's Report presented to members...
Transforming Accountancy, Insurance & Legal Services with AI & DataKTN
UK Research and Innovation will invest up to £12 million in innovation projects to support the application of artificial intelligence (AI) and data technologies. Projects should aim to transform the 3 target sectors:
Accountancy
Insurance
Legal services
Find out more: https://ktn-uk.co.uk/funding/transforming-accountancy-insurance-and-legal-services-with-ai-and-data-small-projects-strand
ONC Market R&D Pilot challenge Webinar finalhealth2dev
The Market R&D Pilot Challenge, brought to you by the Office of the National Coordinator for Health Information Technology (ONC), will help bridge technological gaps by bringing together health care organizations and innovative companies through $300,000 in pilot funding awards and facilitated matchmaking. This webinar provides more detail on the challenge and answers some common questions
Snowball Metrics as Standard Information Agreements - Anna Clements and Peter...CASRAI
Snowball Metrics aim to become the international standard that is endorsed by research-intensive universities so that they can build and monitor the most effective strategies. It is a “bottom-up”, or sector-led, initiative in which universities themselves agree a single method to calculate metrics about their own performance so that they can compare themselves against each other in an apples-to-apples way. This enables them to benchmark and understand their strengths and weaknesses to help to decide in which areas to invest, and in which to divest.
This Webinar will provide delegates with an overview of the Wellcome Trust and RCUK OA policies. It will discuss current levels of compliance, and key issues which need to be addressed if full OA is going to be realised. The Webinar will also discuss the recent study, led by the Wellcome Trust, which looked at what levers funders could pull to help encourage the development of an effective OA market for article processing charges.
NAAASP education and training update March 2016PHEScreening
Public Health England is introducing changes to the education and training for health screeners in the UK National Health Service. A new nationally-recognized Diploma for Health Screeners qualification is being developed, which will provide career progression opportunities for screening staff. The qualification involves 13 mandatory modules covering basic healthcare topics plus screening program-specific modules. Assessment will involve work-based competencies, online tests, assignments, and clinical assessments signed off by trainers. The reaccreditation process for screeners is also being strengthened, with knowledge assessments and scanning evaluations required every two years to maintain standards.
Open Access Progress and Promise in the CGIAR ConsortiumCIARD Movement
The presentation provided an overview and update on the CGIAR Consortium's progress in Open Access, including some of the challenges and opportunities of advocating for Open Access across the Consortium.
The webinar was presented by Piers Bocock, Director of Knowledge Management and Communication at the CGIAR Consortium. He is responsible for overseeing the development and implementation of the Consortium’s Knowledge Management, Communications, and IT strategies, leveraging best practices in these disciplines to help the Consortium deliver on its mandate.
The webinar provided an overview of the EPA Research Call 2022. It covered the introduction to EPA Research 2030 and its focus on achieving environmental objectives. It then discussed the details of the 2022 research call, including the two open topics, application process and timeline, eligibility criteria, and types of funding available. The presentation concluded with guidance on the application process and financial rules, and a Q&A session to address any questions.
Similar to 1 - HRA - Setting up research in the NHS: practical and ethical considerations (20)
This document describes a comparative analysis project that evaluated whether a rapid qualitative analysis approach could deliver findings more quickly than a traditional in-depth analysis method. The rapid analysis used summary templates to analyze data within a short timeframe, while the in-depth analysis used coding and the Framework method. The results found that rapid analysis was much faster for data management but took longer for interpretation. Both methods produced similar key issues and recommendations, but the in-depth analysis provided more specific, context-informed findings. The document reflects on the applications and limitations of rapid qualitative analysis approaches.
This document discusses moving from current ad-hoc healthcare systems to a national learning health system. It outlines challenges facing healthcare like rising costs and an aging population. Current digital health data is underused. Examples show how data can enable epidemiological research, evaluate policies, and support clinical trials. Bigger efforts are needed to create a prototype national asthma learning health system. This would use various data sources to monitor asthma burden, improve outcomes and reduce deaths. The goal is an integrated system that continuously learns from patient care to drive discovery and improve value.
This document discusses stepped wedge cluster randomized trial designs and recent related research. It provides background on cluster studies over time and describes traditional parallel and crossover cluster designs. It then explains classic and modified stepped wedge designs, issues in methodology, and recent related papers addressing topics like sample size calculations and extending CONSORT guidelines. Finally, it proposes future projects on developing CONSORT standards for stepped wedge trials and exploring designs beyond the standard stepped wedge like "dog leg" and ladder designs to improve efficiency.
4 - Further info - Setting up research in the NHS: practical and ethical cons...NIHR CLAHRC West Midlands
This document provides information about a training event on setting up research in the NHS, including practical and ethical considerations. It outlines the day's program, with a lunch break from 12-1pm, and information about an evaluation form that will be circulated by email after the event. It also provides details about an online NIHR ethics learning module, and further information sources like the CLAHRC West Midlands website and how to sign up for their news blog or email the contact listed.
3 - UoB - Setting up research in the NHS: practical and ethical considerationsNIHR CLAHRC West Midlands
Presentation by Prof Heather Draper, University of Birmingham - exploring information provided to research participants/patients during informed consent process
CLAHARC WM Capacity Development Strategy - Nathalie Maillard and Tom MarshallNIHR CLAHRC West Midlands
Presentation to Programme Steering Committee on 14th January 2016 on the CLAHARC WM Capacity Development Strategy. Given by Nathalie Maillard and Tom Marshall.
Feedback from 'speed dating' - Postgrad / Early Career Researcher event 19th ...NIHR CLAHRC West Midlands
The document outlines the programme for a postgraduate and early career researcher event held by CLAHRC West Midlands. The programme includes sessions on ethics, collaboration and engagement, public and patient involvement, networking and peer support, and research methodology. Attendees will discuss topics like navigating ethics reviews, balancing clinical and academic work, engaging stakeholders, and designing sound studies.
The document summarizes a trial called the CO-OPS Trial which studied the effects of fatigue on radiologists' performance in breast cancer screening. It tested whether reversing the order radiologists read screening mammograms (to optimize performance patterns) and taking breaks could help address the normal vigilance decrement seen in tasks requiring sustained attention over long periods. The document outlines the trial methods, results, and interpretations that will be presented on fatigue and changing case order in breast screening radiology.
Rapid qualitative analysis vs the 'traditional approach': early findings and ...NIHR CLAHRC West Midlands
Dr Beck Taylor of Theme 1, Maternity and Child Health, presented her latest project, comparing a rapid approach to synthesising evidence from qualitative research to traditional research methods, presented at CLAHRC WM Programme Steering Committee meeting, 22nd October 2015
Presentation: Dr Amanda Daley, Effectiveness of regular weighing and feedback by community midwives in preventing excessive gestational weight gain (POPS 2) – Theme 1 Maternity & Child Health
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
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TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
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Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
2. Health Research Authority
• Established 2011
• Protect and promote the interests of
patients and the public in research
• Consensus and collaboration on standards
rather than inspection
20 January 2016
3. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
• To make it easier to undertake
responsible health research in the NHS
in England as part of a UK-wide system
Vision
• To simplify the process for approval of
health research for researchers, thus
reducing the time and cost of setting up
studies
Aim
4. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
REC
Favourable
Opinion
HRA
assessment
HRA
Approval
Other
approvals
15 November 2015
5. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
HRA Approval
• Provides assurance to NHS organisations in
England that the study can be undertaken in
NHS.
• A study can start at an organisation when
the organisation has confirmed they have
capacity and capability to deliver the study
– Execution of contract
– Agreement of Statement of Activities
6. Single application HRA Approval
Assess Arrange
HRA Approval and sites
HRA
NHS/ CRN
Site
selection
Confirm
Site list View status
Sponsor Site
confirmed
Arrangements
in place
Agreements
signed
Sponsor invites
site
7. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
When fully implemented
• NIHR CSP no longer required
• All studies (non-portfolio and NIHR CRN
portfolio)
• NHS in England must have regard to HRA
guidance
• Compatible with rest of UK
• Supports preparation for EU Clinical Trials
Regulation
28 December 2015
8. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Pharmacy
and
radiation
Clinical support assurances
Controlled roll out by study type
Cohort 1
Staff studies
May 2015
Cohort 2
Primary care
studies
Aug 2015
Cohort 3
Non-trials
Nov 2015
Cohort 4
Trials/
Investigations
By March
2016
Amendments/newsitesallstudies
28 December 2015
9. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Update on implementation
• Cohort 1 – Live 11th May 2015
• Cohort 2 – Live 10th August 2015
• Cohort 3 - Live 30 Nov 2015
• HRA now accepting Cohort 4 and Cohort 5
type studies – please email
hra.approvalprogramme@nhs.net to discuss
8 March, 2016
10. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Update on implementation
• Confirmed by the end March 2016, HRA Approval
will be the route for submission and Approval in
England.
• CSP will be closed for all new applications
• No requirement to submit SSI forms in NHS
England
8 March, 2016
11. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Update on implementation
• Cohort 4 - clinical trials and clinical investigations in
secondary care
• Cohort 5 – single site, site sponsored studies.
– No requirement to submit Statement of Activities
or schedule of events for Cohort 5 type studies
• Cohort 6 - Studies solely for educational purposes
are currently excluded – continuing to collect views
on appropriate way to manage these studies
8 March, 2016
12. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
• PAF will remain in IRAS and should be submitted as
early as possible via IRAS to CRN
– No change
– Please continue to advise researchers
– Support from CRN is separate to HRA Approval
• Reminder: beyond PAF stage
– HRA Approval studies do not appear in CSP
8 March, 2016
13. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Update on implementation
• Assessment Standards and Criteria (updated 1 Feb 2016)
– Important applicants at least have an idea what
is expected
– IRAS number on participant facing documents
– More clarity re studies that do not require
confirmation of capacity and capability
• Statement of Activities
– Updated version
– Word document plus excel Schedule of Events
8 March, 2016
14. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Statement of Activities – non-commercial
• Submit one template per ‘site
type’ to HRA
• Add known local information
before sending one to each site
as part of local information
package
• Complete the template during
site set-up
• Can act in place of any other
form of site agreement/contract).
15. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Schedule of Events – non-commercial
• Submit one template per ‘site type’ to HRA
• Details activities and their cost attribution
• HRA Approval will not be conditional on
correct attribution or full
research costs but
information will be passed
to sites.
16. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Sponsor
The sponsor takes responsibility for securing the
arrangements to set up, start, manage and finance a
study. Including:
a) confirming that everything is ready for the research
to begin;
b) putting and keeping in place arrangements to set
up, start, finance and manage the study, including its
competent project management and risk management;
c) ensuring that roles and responsibilities of the parties
involved in the research are agreed and appropriately
documented.
3/8/2016
17. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Key premise – sponsor confirms that
everything is ready
• Study is well planned before application to HRA
• Application is of high quality
• Clarity over finance being provided to sites
• CI being clear on their responsibilities to deliver
• Whole system improvement in research delivery starts
with sponsors
3/8/2016
18. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
HRA Expectations of sponsors
• HRA expects that studies applying for HRA
Approval will be ready to start promptly once HRA
Approval issued
• To work closely with participating sites to jointly
agree participation
• Work with sites in a timely fashion to enable them to
confirm capacity and capability
8 March, 2016
19. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk 8 March, 2016
Sponsor
HRAMHRA
CRN
Participating
sites
Sponsor communications
Via study support service
20. High level proposed process with HRA Approval
Applicant
identifies
sites
Applicant
sends local
package to
site team
Joint
arrangement
capacity and
capability
Organisation
confirms
capacity and
capability
Applicant
completes
IRAS Form
Applicant
submits
IRAS pack
to HRA
HRA issues
outcome of
initial
assessment
HRA issues
HRA
Approval to
CI
Applicant
sends HRA
Approval to
site
Applicant
adds initial
HRA letter to
local package
This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Site team = R&D team +
research delivery team (PI,
research nurses, etc) +
LCRN team (for portfolio studies)
See www.rdforum.nhs.uk
contacts
28 December 2015
21. Local Information Pack
12 November 2015
Copy of IRAS application form (combined REC and R&D form) as
submitted for HRA Approval
Protocol and amendments
Participant information and consent documents (without local logos/
headers)
Relevant model agreement
Statement of Activity and Schedule of Event templates – non-commercial
only
NIHR Costing template (validated) and delegation log– commercial only
Any other documents that the sponsor wishes to provide to the site to
support the set up and delivery of the study
Copy of HRA Initial Assessment letter
22. HRA Initial Assessment Letter
• Clarifies if any site types do
not need to confirm capacity
and capability (eg some PICs)
• Flags issues to be resolved
so sites don’t duplicate
• Applicant provides to sites as
part of local document
package
2 February 2016
23. HRA Approval Letter
No provisional or conditional. If
approved:
• Lists documents approved –
including any revised
documents
• Reports outcome of
assessment – including
resolution of issues
2 February 2016
24. 1.Identify 2.Assess 3.Arrange 4.Confirm
5.Site
Initiation
Site
identification
Assess
capacity &
capability
Practical
arranging
Exchange
contracts
Sponsor
initiates site
• Starts before
or after HRA
application
• Network
support if
needed
• Send final
protocol to
research team
and R&D/
LCRN support
• Official site
selection
• Send local
information
pack to
research
team and
R&D/ LCRN
support
(includes
HRA Initial
Assessment
Letter)
• Send contract
for signature
• Site should
be ready to
recruit to
agreed plan
• Send IMP
• Undertake
site initiation
visit
HRA submission
HRA initial
Assessment
letter issued
HRA Approval
letter issued
Site ready to
recruit
This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk 28 December 2015
25. Cross-border studies
• HRA shares outcome of HRA Approval with
devolved nations’ coordinating functions
which conduct additional nation-specific
checks
• Site level process for devolved nation sites
according to each country’s instructions
• Each R&D office for a devolved nation site
will issue a permission letter as well as
signing the contract
2 February 2016
26. 8 March, 2016
HRA - England
Research Ethics Service
Assessment team
Technical Assurance team
Confidentiality Advice Team
UK-wide
IT system
UK-wide
arrangements
Devolved
administrations:
• RECs
• R&D
27. Cross-border studies
• Based on existing UK compatibility
• If Lead R&D office in England – HRA
Approval
• If Lead R&D office elsewhere – study-wide
review
• Outcome shared UK-wide and country-
specific aspects added
• Site set-up according to country process
• REC may be anywhere in UK
2 February 2016
28. Guidance: available on HRA Website
• Guidance for applicants (updated 30 November
2015)
• Guidance for NHS Organisations (updated 30
November 2015)
• Guidance for sponsors/CIs (updated 30 November
2015)
• Illustrative studies (updated 30 November 2015)
29. Guidance available
• HRA Approval Cohort definitions (updated 2 Feb
2016)
• Assessing, Arranging and Confirming: Clarifications
on HRA Terminology (updated 23 November 2015)
• Example template for email to confirm capacity and
capability (created 30 November 2015)
• Listening to feedback during implementation of HRA
Approval (created 30 November 2015)
30. HRA Approval will continue to develop further
• Amendments for studies processed through
previous systems will be incorporated
• Revisions to remaining model agreements
• Revisions to Research Passport guidance
• Develop REC – HRA assessment interaction
• Develop IRAS further
• Prepare for EU Clinical Trials Regulations
20 January 2016
32. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Amendments: Historic studies
• When CSP is switched off, all studies with
amendments or new sites will be processed through
HRA Approval
Applies to all studies:
• led from England,
• with NHS sites in England
• set up prior to CSP
• through CSP
• non-portfolio studies
28 December 2015
33. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Submitting Amendments
• Amendments requiring REC Approval - continue to
submit to REC. Information will be shared internally
with HRA Assessment Team
• Amendments not requiring REC Approval (non-
Substantial Amendments) - submit to
hra.approval@nhs.net
• Sponsor still responsible for determining whether
Amendment is Substantial or non-Substantial
28 December 2015
34. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
MHRA approval
HRA
categorises
amendment
REC review
HRA confirms
compliance with
HRA
assessment
standards
Applicant
submits
amendment to
HRA
HRA confirms
continuing HRA
Approval
28 December 2015
35. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk
Regional Change Lead
Programme implementation queries
hra.approvalprogramme@nhs.net
Specific application enquiries
hra.approval@nhs.net
Check for updates and register for HRA Latest:
www.hra.nhs.uk
36. This presentation is designed to provide general information only. Our website Terms and Conditions apply www.hra.nhs.uk