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NHS R&D Forum News

Title: Newsletter July 2011
Date: 31/07/2011
News:

1. News from the Forum

1.1 Accredited ResearcherTM Programme

Information about this competency assessment programme has been shared with industry colleagues, via the ABPI, and the MHRA so that they are aware of it when you brandish your certificates during inspection or monitoring visits. We look forward to getting their feedback and taking that into account as we further develop the system.

Please remember that it is not the intention for this programme to include a training element. Indeed one of its strengths is that it can be used to demonstrate competency in GCP regardless of how the knowledge was gained.

Liverpool Women's Trust were the first to support the Group Purchase Scheme. Here's what they said:

"On 3rd June 2011 a recommendation was presented to the R&D Committee at Liverpool Women's NHS Foundation Trust with respect to the new scheme designed to assess and accredit researchers working in Clinical Trials in the non-commercial and commercial sectors.  It was felt that the Accredited Researcher Programme, would provide a good method of independent accreditation of researchers, that can be used to demonstrate knowledge that has been acquired either through experience or training to perform a clinical research role.  At the meeting the Committee agreed that the organisation should purchase 25 tokens.  The proposed accreditation was also welcomed enthusiastically by researchers to whom it was offered, who felt that it would provide formal endorsement of their skills following Good Clinical Practice training.  We are now at the stage of encouraging our researchers to take up this opportunity."

Further information is available at http://www.accreditedresearcher.com. If your Trust wants to join Liverpool Women's Trust in leading the way for Accredited Researcher please contact enquiries@accreditedresearcher.com for information on the Group Purchase Scheme.

1.2 Advisory Board

The call for Expressions of Interest generated a lot of interest and we were delighted to receive so many high quality applications. A panel from the existing group reviewed all the applications looking for skills and expertise that complemented that already in the group and trying to achieve a better geographical and sector representation. This meant that we had to turn down very good applications where there was over representation of particular skills or people from certain sectors or geography. The level of interest bodes well for the Forums future and we hope that members might be interested in getting involved in some other way, perhaps joining a working group, taking part in the annual conference or other Forum meetings or, perhaps volunteering to help provide training. 

Our Advisory Group members are now

Art Ationu

Allyson Bailey

Angela Ball

Wendy Butcher

Woody Caan

Nicola Coe

Paul Craven

Mary Cubitt

Mark Dolman

Nancy El-Farargy

Sharon Erb

Rachel Georgiou

Terri Harding

Shona Haining

Iva Hauptmannova

Jemma Hughes

Rhian Hughes

Karen Ignatian

Maria Koufali

Dot Lambert

Lynis Lewis

Carolyn Maloney

Virginia Minogue

Maria Palmer

Jacqui Pirmohamed

Martina Prude

Sarah Rickard

Gary Roper

Maria Thornton

Lisa Vickers


1.3 Forum Training Courses revamped

The Forum courses will be running again the autumn:

  • Fundamentals of Clinical Research
  • Skills for monitoring non-commercial clinical trials
  • Preparing Investigator sites and R&D Depts for GCP Inspections

The course material has been reviewed and updated. Dates and locations will be confirmed soon and a broadcast to members will be sent when bookings open.

1.4 Annual Conference Working Group

The date and location for 2012 Conference will be announced soon. We have received very positive feedback on the programme structure this year and this will be retained for next year. We would now like to invite members to join a Conference Working Group to create the programme and secure speakers for the event. The Group would start in September and discussions will be held via teleconference with the aim of having the programme ready to open bookings before Christmas. If you would like to join this group please email angie.major@rdforum.org.uk.

1.5 Discussion Board

Please help answer questions raised on the Forum discussion board and share your experiences relating to R&D Management. This tool is provided to support the R&D Community and is great way to help others in R&D. You do not have to be a member of the NHS R&D Forum or set up a user account to post messages. Calls for Papers and Fellowships can be added on the Discussion Board too. Some of the recent topics include:

  • Has anyone had any experience yet of producing a DSUR for the MHRA?
    As a non commercial site undertaking mainly phase IV studies, this looks incredibly complicated and any thoughts or advice from colleagues would be welcome as the guidance provided is very slim with the one non commercial example being again quite complicated.
  • At St Mary's University College, we are planning to undertake a survey based research on GP/Dentist's across England and Wales. The research examines GP/Dentist's perception and attitudes over complimentary therapies.
    Do we need to apply for each NHS Trust's R&D Approval or is there a more efficient way to go about? Through my reading of NHS REC documents, it seems like this project does not need any REC approval.
    I am undertaking this research in NHS for the first time and will really appreciate any help on this matter.
  • Hi, we are looking at moving to a web based R&D management system. What should we take a look at, what does everybody else use?

Log on now and post your replies: http://web.rdforum.nhs.uk/forum/forum/

2. DH/NIHR Update

NIHR CRN Industry Study Start-up Route Map

A new route map has been published for industry that sets out a suggested order and offers clear sign posting for obtaining the approvals and permissions to start a study with the NIHR Clinical Research Network.

See http://www.crncc.nihr.ac.uk/life+sciences+industry

Publication of updated NIHR briefing documents 

The NIHR has published updated briefing documents, which sets out the aims and measures the NIHR has put in place to achieve its goals.

http://www.nihr.ac.uk/about/Pages/Briefingdocuments.aspx

2.2 Call for proposals

Public Health Research programme Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Use SHIFT+ENTER to open the menu (new window).

The PHR programme evaluates public health interventions, providing new knowledge on the benefits, costs, acceptability and wider impacts of non-NHS interventions intended to improve the health of the public and reduce inequalities in health. The scope of the programme is multi-disciplinary and broad, covering a range of interventions that improve public health. 
 
Applicants are asked to submit an outline application for the above funding opportunity by 1pm on Monday 15 August 2011.

Link: Find out more

NIHR Public Health Research programme: call for proposals for commissioned researchRight-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Use SHIFT+ENTER to open the menu (new window).

Applicants are invited to submit proposals on the following commissioning brief by 1pm on 22 August 2011:
 
11/3004: Road Safety: The Public Health Impact of Decreasing the amount of Street Lighting

Link: full commissioning brief and application details

DH Policy Research Programme Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Use SHIFT+ENTER to open the menu (new window).

The Department of Health's Policy Research Programme (PRP) invites research proposals in the following areas:

  • Behavioural Interventions to Assist the Response to an Influenza Pandemic in the UK
  • Assessment of the Feasibility of a Study into Possible Long-term Health Effects Associated with Exposure to Static and Time-varying Magnetic Fields from MRI
  • An Investigation of Patient Experience of MRSA Screening
  • Evaluation of the New Medicines Service
  • Development of New Models for Collection and Use of Patient Experience Information in the NHS

The deadline for receipt of full applications is 5pm on Monday, 5 September 2011. 

Link: DH PRP calls

NIHR SDO ProgrammeRight-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Use SHIFT+ENTER to open the menu (new window).

11/1023: open call (special interest in studies with an economic/costing component)

This call focuses on the delivery of health services in care homes. In particular, this will focus on the generation of primary research into the organisation of NHS support for residents of the care home sector.

Applicants are asked to submit outline proposals for the above call by 1pm on Thursday 15 September 2011.

Link: Click here to find out more about this funding opportunity

NIHR SDO ProgrammeRight-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Use SHIFT+ENTER to open the menu (new window).

11/1022: Demand management for planned care

This call relates to research to assess initiatives to contain or manage demand for elective hospital care. The focus is on particular areas of research need that have been identified within the following three themes:

  • Interventions aimed at general practitioners
  • Interventions aimed at specialists and the interface
  • Organisational interventions to manage or divert referrals

These themes are indicative of the wider aims and purpose of this call for proposals, and are not exclusive.  Proposals for research which are not explicitly aligned with one of these areas or themes but which are consistent with the overall aims of this call for organisational research into elective care management are welcomed.
Applicants are asked to submit outline proposals for the above call by 1pm on Thursday 15 September 2011.

Link: Click here to find out more about this funding opportunity

NIHR SDO ProgrammeRight-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Use SHIFT+ENTER to open the menu (new window).

11/1023: open call (special interest in studies with an economic/costing component)

This call focuses on the delivery of health services in care homes. In particular, this will focus on the generation of primary research into the organisation of NHS support for residents of the care home sector.

Applicants are asked to submit outline proposals for the above call by 1pm on Thursday 15 September 2011.

Link: Click here to find out more about this funding opportunity

3. News from other organisations

3.1 AREC publish updated 'Health Research and You' leaflet

CEREs passed the copyright for all documentation to AREC, who have started to update and reproduce information sheets.

To keep costs to a minimum, and also to try and ascertain the demand for this information, AREC have made the first leaflet 'Health Research and You' available to download from the AREC website. If it does prove to be popular, they will add 'Medical Research and YOU' and 'Genetic Research and YOU', aiming eventually to provide a dedicated email address for enquiries, as well as audio cassettes.

To download click the link: http://www.arec.org.uk/health/

3.2 Data Safety Update Reports - Required from 1st Sep 2011

The Development Safety Update Report (DSUR) Guidance (ICH E2F) was published in the EU in September 2010 and is due to be implemented in September 2011. The Commission has agreed to this one year transition period, during which either an ASR or a DSUR may be submitted after which it is expected that all new submissions of annual safety reports will be in the DSUR format covering the preceding 12 months. As of 1 September 2011 only DSUR submissions will be accepted.

Guidance on the DSUR can be found on the ICH DSUR guidance page through the link below. This page also provides example DSURs for both commercial and non commercial sponsors as well details of exemptions and where they are applicable.

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/Safetyreporting-SUSARsandASRs/index.htm#dsur

4. Updating your membership details

We are tidying up the membership database. Please log in to your membership record and make sure your details are up to date. Go to: http://web.rdforum.nhs.uk/manage/member_details.php

There is a password reminder if you've forgotten or mislaid it.

Updating R&D office contact details

The NHS R&D Forum maintains the R&D office contact database on the website as a service to researchers (see Contacting R&D Offices). The R&D Forum website allows you to login and update the contact details we have for your R&D Department. If you have lost your login details or you encounter any difficulties, please contact the Forum.

 

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