Online Form. Welcome to the Integrated Research Application System. IRAS Project Filter

Size: px
Start display at page:

Download "Online Form. Welcome to the Integrated Research Application System. IRAS Project Filter"

Transcription

1 Welcome to the Integrated Research Application System IRAS Project Filter The integrated dataset required for your project will be created from the answers you give to the following questions. The system will generate only those questions and sections which (a) apply to your study type and (b) are required by the bodies reviewing your study. Please ensure you answer all the questions before proceeding with your applications. Please enter a short title for this project (maximum 70 characters) 1. Is your project an audit or service evaluation? 2. Select one category from the list below: Clinical trial of an investigational medicinal product Clinical investigation or other study of a medical device Combined trial of an investigational medicinal product and an investigational medical device Other clinical trial or clinical investigation Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology Study involving qualitative methods only Study limited to working with human tissue samples, other human biological samples and/or data (specific project only) Research tissue bank Research database If your work does not fit any of these categories, select the option below: Other study 2a. Please answer the following question: Is this trial subject to advice from the Expert Advisory Group on Clinical Trials and the Commission on Human Medicine prior to authorisation from MHRA? 2b. Please answer the following question(s): a) Does the study involve the use of any ionising radiation? b) Will you be taking new human tissue samples (or other human biological samples)? c) Will you be using existing human tissue samples (or other human biological samples)? 1

2 3. In which countries of the UK will the research sites be located?(tick all that apply) England Scotland Wales Northern Ireland 4. In completing this form, which bodies are you making an application to? NHS/HSC Research and Development offices Research Ethics Committee Medicines and Healthcare products Regulatory Agency (MHRA) Medicines Gene Therapy Advisory Committee (GTAC) Patient Information Advisory Group (PIAG) Ministry of Justice (MoJ) 5. Will any research sites in this study be NHS organisations? 6. Do you plan to include any participants who are children? 7. Do you plan to include any participants who are adults unable to consent for themselves through physical or mental incapacity? The guidance notes explain how an adult is defined for this purpose. 8. Do you plan to include any participants who are prisoners or young offenders in the custody of HM Prison Service in England or Wales? 9. Is the study, or any part of the study, being undertaken as an educational project? 10. Will identifiable patient data be accessed outside the clinical care team without prior consent at any stage of the project (including identification of potential participants)? Once you have completed the Project Filter, please go to Navigate to view your forms and navigate between questions and sections. From Navigate you can also download and print a Reference Only blank copy of the integrated dataset for your applications. 2

3 Department of Health Administration of Radioactive Substances Advisory Committee (ARSAC) B4. Research It is a requirement of the Medicines (Administration of Radioactive Substances) Regulations 1978 that administrations of radioactive medicinal products to humans should be conducted under certificates issued by the Health Ministers. For research studies where radioactive medicinal products are used, a research certificate is usually required for an applicant at each of the sites participating in the study. The application forms for these certificates can be downloaded from For research, each applicant must complete Parts A, C and B4. Alternatively, Part B4 can be generated from the Integrated Research Application System (IRAS) study form or from the Site Specific Information (SSI) Form completed at each research site. Correct completion of these forms will automatically generate most of the information required to complete Part B4. Additional information should be entered at fields marked ***. This should be submitted, along with signed Parts A and C, to the ARSAC Support Unit, Centre for Radiation, Chemical and Environmental Hazards, Radiation Protection Division, Health Protection Agency, Chilton, Didcot, OX11 0RQ. Administrative information 1. Name of research site: 2. Name of Principal Investigator responsible for conduct of the research at this site: Title Forename/Initials Surname 3. Full title of study: 4. Name of Chief Investigator: Title Forename/Initials Surname 5. Research Ethics Committee to which application for ethical review has been made: Please do not submit ARSAC application until the REC application has been submitted by the Chief Investigator and validated for review. The details below will then be populated from the NRES database. 3

4 Name: Address:... Telephone: REC reference number: Design and purpose of the research 7. Primary research question: Case series/ case note review Case control Cohort observation Controlled trial without randomisation Cross sectional study Database analysis Epidemiology Feasibility/ pilot study Laboratory study Metanalysis Qualitative research Questionnaire, interview or observation study Randomised controlled trial Other (specify) 8. Secondary research questions: Clinical trial of an unlicensed investigational medicinal product Clinical trial of a licensed medicinal product in new conditions of use (different from those in the SmPC, i.e. new target population, new dosage schemes, new administration route, etc.) Clinical trial of a licensed medicinal product used according to the SmPC Other (please specify) 9. Scientific background: Trial to study the pharmacology of a medicinal product with no evidence of potential benefit to proposed participants (Phase 1) Trial to study the safety and dosage levels of, and response to, a medicinal product with no evidence of potential benefit to proposed participants (Phase 1/2a) Therapeutic exploratory trial (Phase 2) Therapeutic exploratory trial including comparison with the standard treatment regimen (Phase 2/3) Therapeutic confirmatory trial (Phase 3) Therapeutic use trial (Phase 4) 4

5 Applicants must enclose a copy of the completed request for authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA). The application form is published as Annex 1 to the European Commission guideline ENTR/CT1 and can be obtained from the EudraCT website at Summary of the purpose, design and methodology of the research: 11. Number of participants: Total UK sample size: Total international sample size (including UK): Further details: 12. How was the number of participants decided upon? If a formal sample size calculation was used, indicate how this was done, giving sufficient information to justify and reproduce the calculation. 13. How many research participants is it expected will be recruited at this site? 5

6 Administration of radioactive materials Complete sub sections A and/or B as applicable with input from relevant experts. It is advisable to discuss the proposed research at an early stage with (a) a Medical Physics Expert and (b) a Clinical Radiation Expert, who will carry out the required assessments for sub sections C and D. The lead MPE can also facilitate the completion of sub sections A and/or B if necessary. 1. Does the study involve exposure to radioactive materials? 2. Does the study involve other diagnostic or therapeutic ionising radiation? You have indicated in the Project Filter that this study involves ionising radiation. At least one of the above categories should be selected. If the study does not involve ionising radiation, please amend your answer in the Project Filter to disable this section. A. Radioactive materials Details of radioactive materials A1. Complete the table below for each radionuclide to be administered. Type of investigation/therapy: Radionuclide: Chemical form: Proposed activity (MBq): Route of administration: Number of administrations per perticipant: Effective dose or target tissue dose per administration: Comment on any variation in clinical practice affecting the dose assesment at this site: A2. Details of study participants Will any of the study participants be patients? Will any of the study participants be healthy volunteers? Details of patients to be studied: Number (whole study) Age range Sex Clinical condition Total effective or target tissue dose per individual Details of healthy volunteers to be studied: Number (whole study) Age range Sex Total effective dose per individual 6

7 A3. ARSAC research certificates An ARSAC research certificate will be required at each research site where the study involves administration of exposures which are additional to normal care. Most of the information required by ARSAC can be generated automatically from Part A and Part B Section 3 of IRAS once completed. The ARSAC research application form can be launched from the Site Specific Information Form for the site in IRAS. 7

8 Administration of other ionising radiation B1. Details of other ionising radiation Give details by completing the table below: Procedure No of procedures Estimated procedure dose (use national Diagnostic Reference Levels where available) 8

9 Dose and risk assessment C1. What is the total research protocol dose from the exposures in A1 and/or B1, and what component of this is the additional dose over and above standard practice? What are the risks associated with these two doses (total and additional)? The dose and risk assessment should be set out below. This should be prepared by a Medical Physics Expert (MPE) who is a registered health care professional and has expertise relevant to the planned exposures. Where the study involves different types of exposure (for example, both radioactive materials and other ionising radiation, or more than one imaging method), advice may need to be sought from other MPEs with relevant expertise. The lead MPE should produce a combined assessment for the ethics committee, giving the names of any other MPEs who have contributed to the assessment. Further guidance is available by clicking on the information button or in the document Approval of research involving ionising radiation, available here: Special attention must be paid to pregnant/potentially pregnant women or those who are breast feeding, or other potentially vulnerable groups listed at Question A24. C2. Declaration by lead Medical Physics Expert I am satisfied that the information in sub sections A and/or B and the assessment in sub section C provide a reasonable estimate of the ionising radiation exposure planned in this research and the associated risks. Signature:.. Date: (dd/mm/yyyy) C3. Details of person acting as lead Medical Physics Expert Title Forename/Initials Surname Post Details of professional registration Organisation Address Post Code Telephone Fax Mobile 9

10 Clinical assessment This sub section should be completed by a Clinical Radiation Expert (CRE) who is a registered health professional with clinical expertise relevant to the planned exposures. The assessment should cover potential exposure at all research sites, taking account of possible variation in normal clinical practice. Where the study involves different types of exposure (for example, both radiotherapy and other ionising radiation), advice may need to be sought from other CREs with relevant expertise. The lead CRE should produce a combined assessment for the ethics committee, giving the names of any other CREs who have contributed to the assessment. The guidance notes give advice to Chief Investigators on who can act as lead Clinical Radiation Expert (CRE) and advice for the CRE on the assessment of exposures having regard to IRMER. Special attention must be paid to pregnant/potentially pregnant women or those who are breast feeding, or other potentially vulnerable groups listed at Question A24. D1. Will the exposure exceed the exposure that might be received as part of normal care at any proposed research site? D2. Assessment of additional exposure Explain how the planned exposure compares with normal practice and assess whether it is appropriate, using language comprehensible to a lay person. Consideration should be given to the specific objectives of the exposure, the characteristics of participants, the potential diagnostic or therapeutic benefits to the participant, the potential benefits to society, the risk to the participant and the availability of alternative techniques involving less, or no, ionising radiation. If pregnant or breast feeding mothers are to be studied give reasons and details of special radiation protection measures to be taken. D3. Declaration by lead Clinical Radiation Expert I am satisfied that the exposure to ionising radiation planned in this research study (as defined in A1 and/or B1) is reasonable and that the risks are adequately described in the participant information sheet for the study. Signature:.. Date: (dd/mm/yyyy) D4. Details of lead Clinical Radiation Expert Title Forename/Initials Surname Post Details of professional registration Organisation Address Post Code Telephone Fax Mobile 10

11 Employers responsible for radiation facilities at research sites must have written procedures to meet the requirements of the Ionising Radiation (Medical Exposure) Regulations 2000 (IRMER). R and D offices for NHS sites will seek confirmation from local radiation experts that local IRMER authorisation procedures have been followed. Where the local Medical Physics Expert or IRMER Practitioner disagrees with the assessments made in this Section and/or the care organisation is unable to adhere to the protocol, this should be discussed with the Chief Investigator and the lead experts for the study. Any necessary variation in the protocol or participant information sheet at particular sites should be notified to the main REC as a substantial amendment and an ethical opinion sought. 11

Integrated Research Application System (IRAS)

Integrated Research Application System (IRAS) Integrated Research Application System (IRAS) Question specific guidance Part B Section 3 Exposure to ionising radiation The following document collates all guidance for the questions in Part B: Section

More information

Specialist Research Ethics Guidance Paper RESEARCH INVOLVING ADULT PARTICIPANTS WHO LACK THE CAPACITY TO CONSENT

Specialist Research Ethics Guidance Paper RESEARCH INVOLVING ADULT PARTICIPANTS WHO LACK THE CAPACITY TO CONSENT Specialist Research Ethics Guidance Paper RESEARCH INVOLVING ADULT PARTICIPANTS WHO LACK THE CAPACITY TO CONSENT This note covers all research undertaken at the University that involves the recruitment

More information

Radiation Assurance Research Exposure Form

Radiation Assurance Research Exposure Form Radiation Assurance Research Exposure Form F1: To be completed by the applicant This section is to be completed by the applicant before submission of the application for Radiation Assurance. The HRA will

More information

Consent to research. A draft for consultation

Consent to research. A draft for consultation Consent to research A draft for consultation 1 Consent to research About the guidance Our guidance Consent: patients and doctors making decisions together (2008) 1 sets out the principles of good practice

More information

NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: SOP number: SOP category: Version number: 03 Version date: 19 December 2016 Effective date: 19 January 2017 Revision due date: 19 January 2020 NEWCASTLE CLINICAL TRIALS UNIT STANDARD

More information

Carolyn Costigan and Andrea Shemilt Nottingham University Hospitals NHS Trust

Carolyn Costigan and Andrea Shemilt Nottingham University Hospitals NHS Trust Carolyn Costigan and Andrea Shemilt Nottingham University Hospitals NHS Trust Why we are vigilant about radiation About R&DISU Streamlining research processes involving imaging and radiation Supporting

More information

Chief Dental Officer England: Advice on commercial practice of online registered dental practitioners selling patient group directions for NHS

Chief Dental Officer England: Advice on commercial practice of online registered dental practitioners selling patient group directions for NHS Chief Dental Officer England: Advice on commercial practice of online registered dental practitioners selling patient group directions for NHS England commissioned services. Chief Dental Officer England:

More information

DIRECT ACCESS - Guidance to BSDHT Members

DIRECT ACCESS - Guidance to BSDHT Members DIRECT CCESS - Guidance to BSDHT Members Direct ccess came into effect from 1 May 2013. But what does it mean for dental hygienists and dental therapists? The GDC have published guidance notes on the subject

More information

IONISING RADIATIONS REGULATIONS 2017 REGULATIONS 5, 6, AND 7. NOTIFICATION, REGISTRATION AND CONSENT

IONISING RADIATIONS REGULATIONS 2017 REGULATIONS 5, 6, AND 7. NOTIFICATION, REGISTRATION AND CONSENT ONR Guidance to the Ionising Radiations Regulations 2017 Notification, Registration, and Consent Guidance IONISING RADIATIONS REGULATIONS 2017 REGULATIONS 5, 6, AND 7. NOTIFICATION, REGISTRATION AND CONSENT

More information

Information provided to Duchenne muscular dystrophy patient organisations regarding Raxone

Information provided to Duchenne muscular dystrophy patient organisations regarding Raxone Information provided to Duchenne muscular dystrophy patient organisations regarding Raxone (idebenone) and the Early Access to Medicines Scheme in the UK (EAMS 46555/0001) April 26 th 2018 Raxone tablets

More information

Ionising Radiation Policy

Ionising Radiation Policy Document Author Written By: Radiation Protection Adviser Authorised Authorised By: Chief Executive Date: 24/08/2018 Date: 22 nd vember 2018 Lead Director: Consultant Radiologist Effective Date: 22 nd vember

More information

Health and Safety Policy Arrangements: Radiation Protection Guidelines

Health and Safety Policy Arrangements: Radiation Protection Guidelines Health and Safety Policy Arrangements: Radiation Protection Guidelines Author: Dr N. Sarrami Date of Approval: 12//2010 Due Review Date: 12//2012 1 Radiation Protection Guidelines CONTENTS Section Section

More information

Protecting Vulnerable Groups Guidance for Care Inspectorate staff and service providers Publication date: October 2012

Protecting Vulnerable Groups Guidance for Care Inspectorate staff and service providers Publication date: October 2012 Protecting Vulnerable Groups Guidance for Care Inspectorate staff and service providers Publication date: October 2012 Publication code: OPS-10-12-195 Protecting Vulnerable Groups - Guidance for Care Inspectorate

More information

Trust Policy 218 Ionising Radiation Safety Policy

Trust Policy 218 Ionising Radiation Safety Policy Trust Policy 218 Ionising Radiation Safety Policy Purpose Date Version August 2016 7 To ensure that Plymouth Hospitals NHS Trust complies with all relevant legislation with regard to the use of ionising

More information

Document Control Report

Document Control Report Document Control Report Title Recording Clinical Evaluation and Dose - IR(ME)R 2000 Standard Operating Procedure Author Gill Kite Author s job title Senior Radiographer Directorate Sub-directorate Department

More information

Guidance on colleague and patient questionnaires

Guidance on colleague and patient questionnaires Guidance on colleague and patient questionnaires 2 Revalidation is the process by which doctors must demonstrate to the General Medical Council (GMC), normally every five years, that they are up to date

More information

making a referral for breast imaging Standard Operating Procedure

making a referral for breast imaging Standard Operating Procedure Document Control Title Reporting Radiographer Author Directorate Surgery Date Version Issued 0.1 May 2016 Status Draft Author s job title Reporting Radiographer Department Breast Imaging Comment / Changes

More information

Medical Device Alert. Device Non CE-marked portable dental X-ray units. Including the Tianjie Dental Falcon. Action by

Medical Device Alert. Device Non CE-marked portable dental X-ray units. Including the Tianjie Dental Falcon. Action by Medical Device Alert Issued: 16 July 2012 at 15:30 Device Non CE-marked portable dental X-ray units. Including the Tianjie Dental Falcon. Problem Testing by the Health Protection Agency (HPA) has revealed

More information

RADIATION SAFETY POLICY. Controlled Document Number: Version Number: 3 Controlled Document Sponsor: Controlled Document Lead: Approved By:

RADIATION SAFETY POLICY. Controlled Document Number: Version Number: 3 Controlled Document Sponsor: Controlled Document Lead: Approved By: RADIATION SAFETY POLICY CONTROLLED DOCUMENT CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Version Number: 3 Controlled Document Sponsor: Controlled Document Lead: Approved By: Policy Health

More information

Application form for an Annual Practising Certificate 2018/2019 Application form for updating Practising Status 2018/2019 (Annual Renewal)

Application form for an Annual Practising Certificate 2018/2019 Application form for updating Practising Status 2018/2019 (Annual Renewal) Application form for an Annual Practising Certificate 2018/2019 Application form for updating Practising Status 2018/2019 (Annual Renewal) Important Notification under sections 26 & 144 of the Health Practitioners

More information

Research involving adults lacking the capacity to consent: The Mental Capacity Act 2005

Research involving adults lacking the capacity to consent: The Mental Capacity Act 2005 Research involving adults lacking the capacity to consent: The Mental Capacity Act 2005 Dr Michael Dunn The Ethox Centre University of Oxford michael.dunn@ethox.ox.ac.uk This presentation will: Introduction

More information

Directed Enhanced Service (DES) for H1N1 Vaccination Programme JCVI priority groups

Directed Enhanced Service (DES) for H1N1 Vaccination Programme JCVI priority groups Directed Enhanced Service (DES) for H1N1 Vaccination Programme JCVI priority groups October 2009 Introduction NHS Employers and the General Practitioners Committee (GPC) of the BMA have agreed arrangements

More information

Application form for an Annual Practising Certificate 2017/2018 Application form for updating Practising Status 2017/2018 (Annual Renewal)

Application form for an Annual Practising Certificate 2017/2018 Application form for updating Practising Status 2017/2018 (Annual Renewal) Application form for an Annual Practising Certificate 2017/2018 Application form for updating Practising Status 2017/2018 (Annual Renewal) Important Notification under sections 26 & 144 of the Health Practitioners

More information

Information and Guidance

Information and Guidance Health and Safety Executive (HSE) 1 The practice has registered with the HSE that radiographic equipment is being used on the premise and confirmed compliance with IRR17 by 5/2/2018. 2 HSE have confirmed

More information

NOTICE OF SUBSTANTIAL AMENDMENT

NOTICE OF SUBSTANTIAL AMENDMENT NOTICE OF SUBSTANTIAL AMENDMENT For use in the case of all research other than clinical trials of investigational medicinal products (CTIMPs). For substantial amendments to CTIMPs, please use the EU-approved

More information

THE UNIVERSITY OF HONG KONG Human Research Ethics Committee for Non-Clinical Faculties Application Form for Ethical Approval

THE UNIVERSITY OF HONG KONG Human Research Ethics Committee for Non-Clinical Faculties Application Form for Ethical Approval 50/1011 amended THE UNIVERSITY OF HONG KONG Human Research Ethics Committee for n-clinical Faculties Application Form for Ethical Approval For official use: Ref..: Received date: tes: (1) Please read carefully

More information

PLEASE COMPLETE ALL RELEVANT SECTIONS OF THIS FORM

PLEASE COMPLETE ALL RELEVANT SECTIONS OF THIS FORM APPLICATION FOR INCLUSION IN THE DENTAL LIST OF THE HEALTH AND SOCIAL CARE BOARD PLEASE COMPLETE ALL RELEVANT SECTIONS OF THIS FORM Return the completed form to the Health and Social Care Board local office

More information

The checklist for the use of Ionising Radiation in Primary Dental Care. Not fully compliant

The checklist for the use of Ionising Radiation in Primary Dental Care. Not fully compliant The checklist for the use of Ionising Radiation in Primary Dental Care Health and Safety Executive (HSE) 1 The practice has registered with the HSE that radiographic equipment is being used on the premise

More information

Procedure. Identify all possible radiation hazards.

Procedure. Identify all possible radiation hazards. Guidance Notes on Radiation Risk Assessment Prior to commencing any new work practice involving a source of ionising radiation it is important that a realistic assessment of the radiation risks is carried

More information

Alcohol interventions in secondary and further education

Alcohol interventions in secondary and further education National Institute for Health and Care Excellence Guideline version (Draft for Consultation) Alcohol interventions in secondary and further education NICE guideline: methods NICE guideline Methods

More information

STANDARD OPERATING PROCEDURE SOP 720 RISK ASSESSMENT OF TRIALS SPONSORED. BY THE NNUH and UEA

STANDARD OPERATING PROCEDURE SOP 720 RISK ASSESSMENT OF TRIALS SPONSORED. BY THE NNUH and UEA STANDARD OPERATING PROCEDURE SOP 720 RISK ASSESSMENT OF TRIALS SPONSORED BY THE NNUH and UEA Version 1.0 Version date 13.12.2016 Effective date 13.12.2016 Number of pages 11 pages Review date November

More information

Dear Colleague GENERAL OPHTHALMIC SERVICES OPTOMETRY INDEPENDENT PRESCRIBING. Summary

Dear Colleague GENERAL OPHTHALMIC SERVICES OPTOMETRY INDEPENDENT PRESCRIBING. Summary NHS: PCA(O)(2013)4 Health and Social Care Integration Directorate Primary Care Division Dear Colleague GENERAL OPHTHALMIC SERVICES OPTOMETRY INDEPENDENT PRESCRIBING Summary 1. This letter advises NHS Boards

More information

Response to Scottish Government A Consultation on Electronic Cigarettes and Strengthening Tobacco Control in Scotland December 2014

Response to Scottish Government A Consultation on Electronic Cigarettes and Strengthening Tobacco Control in Scotland December 2014 Responseto ScottishGovernment AConsultationonElectronicCigarettesand StrengtheningTobaccoControlinScotland December2014 Contact Janice Oman Scotland Representation Manager National Pharmacy Association

More information

Diabetes is a lifelong, chronic. Survey on the quality of diabetes care in prison settings across the UK. Keith Booles

Diabetes is a lifelong, chronic. Survey on the quality of diabetes care in prison settings across the UK. Keith Booles Survey on the quality of diabetes care in prison settings across the UK Article points 1. The Royal College of Nursing Diabetes Forum conducted an audit of prisons within the UK to determine the level

More information

NIIM HREC: TGA AUTHORISED PRESCRIBER SCHEME APPLICATION APPROVAL PROCEDURES 1. Procedures Statement

NIIM HREC: TGA AUTHORISED PRESCRIBER SCHEME APPLICATION APPROVAL PROCEDURES 1. Procedures Statement NIIM HREC: TGA AUTHORISED PRESCRIBER SCHEME APPLICATION APPROVAL PROCEDURES 1. Procedures Statement The aim of these procedures is to set out the processes for applications to the NIIM Human Research Ethics

More information

THE MENTAL CAPACITY ACT FACT SHEET FOR SOCIAL SCIENTISTS

THE MENTAL CAPACITY ACT FACT SHEET FOR SOCIAL SCIENTISTS THE MENTAL CAPACITY ACT FACT SHEET FOR SOCIAL SCIENTISTS 1. What is the Mental Capacity Act? 1.1 The Mental Capacity Act 2005 (MCA) 1 provides a statutory framework for people who may not be able to make

More information

Ionising Radiation Policy

Ionising Radiation Policy Ionising Radiation Policy CONTENTS 1. University Policy. 2. Procedures / Guidance. 2.1 Responsibilities of the Deans of Schools and/or Heads of Departments 2.2 Radiation Protection Advisor / Radiation

More information

National Lung Cancer Audit outlier policy 2017

National Lung Cancer Audit outlier policy 2017 National Lung Cancer Audit outlier policy 2017 The National Lung Cancer Audit (NLCA) publishes detailed information on the treatment of lung cancer patients, including the outcome of that treatment. Data

More information

DIRECT ACCESS Guidance to BSDHT Members

DIRECT ACCESS Guidance to BSDHT Members DIRECT CCESS Guidance to BSDHT Members Direct ccess comes into effect from 1 May 2013. But what does it mean for dental hygienists and dental therapists? The GDC have published guidance notes on the subject

More information

Men s consent to the use and storage of sperm or embryos for surrogacy

Men s consent to the use and storage of sperm or embryos for surrogacy HFEA MSG form Men s consent to the use and storage of sperm or embryos for surrogacy About this form This form is produced by the Human Fertilisation and Embryology Authority (HFEA), the UK s independent

More information

Application for Ethical Approval of Research Proposals

Application for Ethical Approval of Research Proposals Application for Ethical Approval of Research Proposals Title of Research Researcher s Name Trinity Email Address Supervisor Name (if applicable) Supervisor Email (if applicable) Category of Proposer (please

More information

Medical gap arrangements - practitioner application

Medical gap arrangements - practitioner application Medical gap arrangements - practitioner application For services provided in a licensed private hospital or day hospital facility (Private Hospital) only. Please complete this form to apply for participation

More information

Tenant & Service User Involvement Strategy

Tenant & Service User Involvement Strategy Tenant & Service User Involvement Strategy Policy No: HM 07 Page: 1 of 9 Tenant & Service User Involvement Strategy 1. Introduction 1.1 Loreburn's Mission Statement is "Delivering Excellence" and we see

More information

Life After Prostate Cancer Diagnosis Research Study

Life After Prostate Cancer Diagnosis Research Study Life After Prostate Cancer Diagnosis Research Study If you are looking at this information sheet this means you have read the covering letter and therefore have had a diagnosis of prostate cancer. If you

More information

The Nutrition (Amendment) (EU Exit) Regulations 2018

The Nutrition (Amendment) (EU Exit) Regulations 2018 The Nutrition (Amendment) (EU Exit) Regulations 2018 A public consultation Contents Introduction... 3 Why we are consulting... 4 Nutrition and Health Claims... 6 Proposals... 6 Vitamins, minerals, and

More information

Appendix I. List of stakeholders consulted with on the Patient Radiation Protection Manual and members of the Medical Exposure Radiation Unit

Appendix I. List of stakeholders consulted with on the Patient Radiation Protection Manual and members of the Medical Exposure Radiation Unit References References The accuracy, quality and relevance of these works are not guaranteed or uniform and more recent information may have superseded these works. This list is not exhaustive. It does

More information

The Accessible Information Standard - guidance for practices

The Accessible Information Standard - guidance for practices The Accessible Information Standard - guidance for practices The Accessible Information Standard guidance for practices The Accessible Information Standard (AIS) known officially as SCCI1605 Accessible

More information

Medical Devices - Reporting to MHRA.. Emma Rooke, December 2015

Medical Devices - Reporting to MHRA.. Emma Rooke, December 2015 Medical Devices - Reporting to MHRA. Emma Rooke, December 2015 Topics to be covered today: The MHRA and what we do What is a Medical Device? Adverse Incidents Reporting adverse incidents to the MHRA The

More information

CNHC Guidance on The Cancer Act (Please note this does not constitute legal advice)

CNHC Guidance on The Cancer Act (Please note this does not constitute legal advice) CNHC Guidance on The Cancer Act 1939 (Please note this does not constitute legal advice) 1. Introduction 1.1. In November 2012 CNHC produced Advertising Guidance to support CNHC registered practitioners

More information

Education and Training Committee 15 November 2012

Education and Training Committee 15 November 2012 Education and Training Committee 15 November 2012 Review of the process of approval of hearing aid dispenser pre-registration education and training programmes. Executive summary and recommendations Introduction

More information

Generic risk statements regarding ionising radiation for MPE and CRE statements in the IRAS application form and Participant Information Sheets

Generic risk statements regarding ionising radiation for MPE and CRE statements in the IRAS application form and Participant Information Sheets Generic risk statements regarding ionising radiation for MPE and CRE statements in the IRAS application form and Participant s Please note that this document is intended for consultation in use. Feedback

More information

Professional Development: proposals for assuring the continuing fitness to practise of osteopaths. draft Peer Discussion Review Guidelines

Professional Development: proposals for assuring the continuing fitness to practise of osteopaths. draft Peer Discussion Review Guidelines 5 Continuing Professional Development: proposals for assuring the continuing fitness to practise of osteopaths draft Peer Discussion Review Guidelines February January 2015 2 draft Peer Discussion Review

More information

Care and Social Services Inspectorate Wales. Care Standards Act Inspection Report. ategi Shared Lives Scheme. Cardiff

Care and Social Services Inspectorate Wales. Care Standards Act Inspection Report. ategi Shared Lives Scheme. Cardiff Care and Social Services Inspectorate Wales Care Standards Act 2000 Inspection Report ategi Shared Lives Scheme Cardiff Type of Inspection Focused Date of inspection Monday, 11 January 2016 Date of publication

More information

On successful completion of the Unit the learner will be able to:

On successful completion of the Unit the learner will be able to: Higher National Unit specification General information Unit code: H9R8 34 Superclass: PF Publication date: September 2015 Source: Scottish Qualifications Authority Version: 03 Unit purpose This Unit is

More information

COMPETENT AUTHORITY (UK) MEDICAL DEVICES DIRECTIVES GUIDANCE NOTES FOR MANUFACTURERS OF DENTAL APPLIANCES

COMPETENT AUTHORITY (UK) MEDICAL DEVICES DIRECTIVES GUIDANCE NOTES FOR MANUFACTURERS OF DENTAL APPLIANCES COMPETENT AUTHORITY (UK) 10 EC MEDICAL DEVICES DIRECTIVES GUIDANCE NOTES FOR MANUFACTURERS OF DENTAL APPLIANCES (CUSTOM MADE DEVICES) Updated March 2008 CONTENTS PAGE Introduction 3 Definition of dental

More information

Standard Operating Procedure Research Governance

Standard Operating Procedure Research Governance Queen s University Belfast Research and Enterprise Standard Operating Procedure Research Governance Title: Application to MHRA for Clinical Trials Authorisation SOP Reference QUB-ADRE-OlO Date prepared

More information

MSc Criminology with Forensic Psychology

MSc Criminology with Forensic Psychology Programme Specification for MSc Criminology with Forensic Psychology 1. Programme title MSc Criminology with Forensic Psychology 2. Awarding institution Middlesex University 3. Teaching institution Middlesex

More information

Questions for ionising radiation applications

Questions for ionising radiation applications Questions for ionising radiation applications Note from HSE November 2017 This document represents a near-final draft of the questions that HSE will be asking those who apply via the graded approach online

More information

Ref: E 007. PGEU Response. Consultation on measures for improving the recognition of medical prescriptions issued in another Member State

Ref: E 007. PGEU Response. Consultation on measures for improving the recognition of medical prescriptions issued in another Member State Ref:11.11.24E 007 PGEU Response Consultation on measures for improving the recognition of medical prescriptions issued in another Member State PGEU The Pharmaceutical Group of the European Union (PGEU)

More information

Specialist List in Special Care Dentistry

Specialist List in Special Care Dentistry Specialist List in Special Care Dentistry Definition of Special Care Dentistry Special Care Dentistry (SCD) is concerned with providing enabling the delivery of oral care for people with an impairment

More information

IRMER Ionising Radiation Medical Exposure Regulations

IRMER Ionising Radiation Medical Exposure Regulations IRMER Ionising Radiation Medical Exposure Regulations Download for information at www.scottishdental.org IONISING RADIATION (MEDICAL EXPOSURE ) REGULATION 2000 (as Amended) (IR(ME)R AN EXPLANATION GUIDE

More information

How is the introduction of a new medicine regulated in the UK?

How is the introduction of a new medicine regulated in the UK? Information provided to Duchenne muscular dystrophy patient organisations regarding Raxone (idebenone) and the Early Access to Medicines Scheme in the UK (EAMS 46555/0001) A medicine called Raxone, which

More information

We are currently recruiting new members to advisory groups for the following research programmes:

We are currently recruiting new members to advisory groups for the following research programmes: Information for applicants to join NIHR as an advisory group member: HTA Programme Topic Identification, Development and Evaluation (TIDE) panel Chairs 1. Background information The goal of the National

More information

Low back pain and sciatica in over 16s NICE quality standard

Low back pain and sciatica in over 16s NICE quality standard March 2017 Low back pain and sciatica in over 16s NICE quality standard Draft for consultation This quality standard covers the assessment and management of non-specific low back pain and sciatica in young

More information

MEAT CONTENT CALCULATION

MEAT CONTENT CALCULATION MEAT CONTENT CALCULATION Introduction Amendments to the European Labelling Directive have resulted in the need to harmonise the definition of meat across Europe. This new definition attempts to ensure

More information

SMOKING OUTSIDE HOSPITALS: AN OPPORTUNITY TO COMMENT ON PROPOSALS

SMOKING OUTSIDE HOSPITALS: AN OPPORTUNITY TO COMMENT ON PROPOSALS Population Health Directorate Health Improvement Division T: 0131-244 1707 E: elaine.mitchell@gov.scot Monday, 28 November, 2016 Dear Chief Executive, SMOKING OUTSIDE HOSPITALS: AN OPPORTUNITY TO COMMENT

More information

1. NHS (GENERAL DENTAL SERVICES) (SCOTLAND) AMENDMENT REGULATIONS AMENDMENT NO 136 TO THE STATEMENT OF DENTAL REMUNERATION

1. NHS (GENERAL DENTAL SERVICES) (SCOTLAND) AMENDMENT REGULATIONS AMENDMENT NO 136 TO THE STATEMENT OF DENTAL REMUNERATION MEMORANDUM TO NHS: PCA(D)(2017)6 DENTISTS/DENTAL BODIES CORPORATE NATIONAL HEALTH SERVICE GENERAL DENTAL SERVICES 1. NHS (GENERAL DENTAL SERVICES) (SCOTLAND) AMENDMENT REGULATIONS 2017 2. AMENDMENT NO

More information

Statistics from the Northern Ireland Drug Misuse Database: 1 April March 2012

Statistics from the Northern Ireland Drug Misuse Database: 1 April March 2012 Statistics from the Northern Ireland Drug Misuse Database: 1 April 2011 31 March 2012 This bulletin summarises information on people presenting to services with problem drug misuse and relates to the 12-month

More information

MDCH IRB REVIEW APPLICATION Authority: Code of Federal Regulations Title 45 Part 46

MDCH IRB REVIEW APPLICATION Authority: Code of Federal Regulations Title 45 Part 46 The Michigan Department of Community Health Institutional Review Board for the Protection of Human Research Subjects Capitol View Building, 7 th Floor, 201 Townsend Street, Lansing, MI 48913 Phone: 517/241-1928

More information

Human Subject Institutional Review Board Proposal Form

Human Subject Institutional Review Board Proposal Form FOR IRB USE ONLY Protocol Number: IRB- Human Subject Institutional Review Board Proposal Form Activity Title: PRINCIPAL INVESTIGATOR ASSURANCE I agree to use procedures with respect to safeguarding human

More information

Research Summary 7/10

Research Summary 7/10 Research Summary 7/10 Analytical Services exists to improve policy making, decision taking and practice by the Ministry of Justice. It does this by providing robust, timely and relevant data and advice

More information

Day care and childminding: Guidance to the National Standards

Day care and childminding: Guidance to the National Standards raising standards improving lives Day care and childminding: Guidance to the National Standards Revisions to certain criteria October 2005 Reference no: 070116 Crown copyright 2005 Reference no: 070116

More information

Primary Care Dental Services Clinical Governance Framework. May 2006 (Updated)

Primary Care Dental Services Clinical Governance Framework. May 2006 (Updated) Primary Care Dental Services Clinical Governance Framework May 2006 (Updated) Primary Care Dental Services Clinical Governance Framework 2 Clinical Governance Framework Guidance for Primary Care Dental

More information

IRB EXPEDITED REVIEW

IRB EXPEDITED REVIEW IRB EXPEDITED REVIEW Research activities that (1) present no more than minimal risk* to human research participants, and (2) involve only procedures listed in one or more of the following categories may

More information

CORPORATE REPORT Communication strategy

CORPORATE REPORT Communication strategy CORPORATE REPORT Communication Strategy 2014-17 1 Introduction This strategy sets out the Commission s goals and objectives in relation to its communication activities for the next three years. It has

More information

Specific Accreditation Guidance OECD GLP

Specific Accreditation Guidance OECD GLP Specific Accreditation Guidance OECD GLP Information for GLP Study Sponsors January 2018 Copyright National Association of Testing Authorities, Australia 2013 This publication is protected by copyright

More information

A Guide to the Scottish Medicines Consortium

A Guide to the Scottish Medicines Consortium A Guide to the Scottish Medicines Consortium Providing advice about newly licensed medicines www.scottishmedicines.org About the Scottish Medicines Consortium The Scottish Medicines Consortium (SMC) provides

More information

Last Name First name Academic degrees. Professional titles and/or work position within your home institution

Last Name First name Academic degrees. Professional titles and/or work position within your home institution Date received stamp ETHICS AND RESEARCH APPLICATION FORM Kenyatta National Hospital/University of Nairobi KEMRI CENTERS ETHICS RESEARCH COMMITTEE Application Number Submit three copies of this form (including

More information

The Professional Relationships Associated with the Practice of Dental Therapy Practice Standard

The Professional Relationships Associated with the Practice of Dental Therapy Practice Standard The Professional Relationships Associated with the Practice of Dental Therapy Practice Standard December 2006 I:\Communications\C7 - Website\Practice standards rebranded Aug15\Dental therapy working relationship

More information

INDEX Pages. 1. Conditions which are normally included in all determinations of conditional registration Alleged health issues...

INDEX Pages. 1. Conditions which are normally included in all determinations of conditional registration Alleged health issues... IO ONDITIONS BANK INDEX Pages 1. onditions which are normally included in all determinations of conditional registration 1 2. Alleged health issues... 2 3. Alleged personal alcohol and/or drug misuse problems...2

More information

The statutory regulation of dance movement therapists

The statutory regulation of dance movement therapists The statutory regulation of dance movement therapists Responses to the consultation 1. Introduction... 2 1.1 About the consultation... 2 1.2 About us... 2 1.3 About statutory regulation... 2 1.4 The path

More information

Annual Progress and Safety Reporting SOP for HEY-sponsored CTIMPs

Annual Progress and Safety Reporting SOP for HEY-sponsored CTIMPs R&D Department Annual Progress and Safety Reporting SOP for HEY-sponsored CTIMPs Hull and East Yorkshire Hospitals NHS Trust 2010 All Rights Reserved No part of this document may be reproduced, stored

More information

Your consent to your sperm and embryos being used in treatment and/or stored (IVF and ICSI)

Your consent to your sperm and embryos being used in treatment and/or stored (IVF and ICSI) HFEA MT form (Gender-neutral version) Your consent to your sperm and embryos being used in treatment and/or stored (IVF and ICSI) About this form This form is produced by the Human Fertilisation and Embryology

More information

Radon Guidance for Local Authorities

Radon Guidance for Local Authorities Radon Guidance for Local Authorities Description and Background Radon is an odourless, colourless, radioactive gas that occurs naturally. It is released from certain rocks and the risk of occurrence varies

More information

Care and Social Services Inspectorate Wales

Care and Social Services Inspectorate Wales Care and Social Services Inspectorate Wales Service Regulation and Inspection Guidance on inspecting welfare provision in boarding schools, residential special schools and accommodation of students under

More information

What s my story? A guide to using intermediaries to help vulnerable witnesses

What s my story? A guide to using intermediaries to help vulnerable witnesses What s my story? A guide to using intermediaries to help vulnerable witnesses Intermediaries can be the difference between vulnerable witnesses communicating their best evidence or not communicating at

More information

NOTICE OF SUBSTANTIAL AMENDMENT

NOTICE OF SUBSTANTIAL AMENDMENT NOTICE OF SUBSTANTIAL AMENDMENT For use in the case of all research other than clinical trials of investigational medicinal products (CTIMPs). For substantial amendments to CTIMPs, please use the EU-approved

More information

NOT PROTECTIVELY MARKED. Interpreters

NOT PROTECTIVELY MARKED. Interpreters Interpreters Contents Policy Statement... 2... 2 After Using an Interpreter... 3 LE Unable to Provide a Service... 3 Service Issues... 4 Defence Solicitor Requires Interpreter... 4 Interpreters for Crown

More information

Using selective internal radiation therapy to treat bowel cancer that has spread to the liver

Using selective internal radiation therapy to treat bowel cancer that has spread to the liver Understanding NICE guidance Information for people who use NHS services Using selective internal radiation therapy to treat bowel cancer that has spread to the liver NICE interventional procedures guidance

More information

NHS. High dose rate brachytherapy for carcinoma of the cervix. National Institute for Health and Clinical Excellence. Issue date: March 2006

NHS. High dose rate brachytherapy for carcinoma of the cervix. National Institute for Health and Clinical Excellence. Issue date: March 2006 NHS National Institute for Health and Clinical Excellence Issue date: March 2006 High dose rate brachytherapy for carcinoma of Understanding NICE guidance information for people considering the procedure,

More information

USE OF UNLICENSED MEDICINES AND OFF-LABEL MEDICINES WHERE A LICENSED MEDICINE IS AVAILABLE

USE OF UNLICENSED MEDICINES AND OFF-LABEL MEDICINES WHERE A LICENSED MEDICINE IS AVAILABLE NHS Scotland Directors of Pharmacy and Scottish Association of Medical Directors USE OF UNLICENSED MEDICINES AND OFF-LABEL MEDICINES WHERE A LICENSED MEDICINE IS AVAILABLE CONSENSUS STATEMENT This consensus

More information

Access to newly licensed medicines. Scottish Medicines Consortium

Access to newly licensed medicines. Scottish Medicines Consortium Access to newly licensed medicines Scottish Medicines Consortium Modifiers The Committee has previously been provided with information about why the SMC uses modifiers in its appraisal process and also

More information

THE RESPONSIBLE PHARMACIST REGULATIONS

THE RESPONSIBLE PHARMACIST REGULATIONS THE RESPONSIBLE PHARMACIST REGULATIONS A SUMMARY OF THE RESPONSES TO PUBLIC CONSULTATION ON PROPOSALS FOR THE CONTENT OF THE REGULATIONS DH INFORMATION READER BOX Policy HR / Workforce Management Planning

More information

PATIENT GROUP DIRECTION (PGD) Supply of potassium iodide 65mg tablets to adults and children exposed to, or at risk of exposure to radioactive iodine

PATIENT GROUP DIRECTION (PGD) Supply of potassium iodide 65mg tablets to adults and children exposed to, or at risk of exposure to radioactive iodine PHE publications gateway number: PATIENT GROUP DIRECTION (PGD) Supply of potassium iodide 65mg tablets to adults and children exposed to, or at risk of exposure to radioactive iodine For the supply of

More information

Costing report: Lipid modification Implementing the NICE guideline on lipid modification (CG181)

Costing report: Lipid modification Implementing the NICE guideline on lipid modification (CG181) Putting NICE guidance into practice Costing report: Lipid modification Implementing the NICE guideline on lipid modification (CG181) Published: July 2014 This costing report accompanies Lipid modification:

More information

Hybrid imaging guidance on legislative, reporting and training aspects

Hybrid imaging guidance on legislative, reporting and training aspects Hybrid imaging guidance on legislative, reporting and training aspects The Royal College of Radiologists Royal College of Physicians of London Royal College of Physicians and Surgeons of Glasgow Royal

More information

MEDICINES, MEDICAL DEVICES, TREATMENTS AND HEALTH

MEDICINES, MEDICAL DEVICES, TREATMENTS AND HEALTH 11 MEDICINES, MEDICAL DEVICES, TREATMENTS AND HEALTH Background The rules in this section are designed to ensure that advertisements that include health claims (please see Section 13 for health claims

More information

General Dental Practice Inspection (Announced) Parkway Cosmetic and Dental Spa (Private Dental Practice) Inspection date: 25 July 2016

General Dental Practice Inspection (Announced) Parkway Cosmetic and Dental Spa (Private Dental Practice) Inspection date: 25 July 2016 General Dental Practice Inspection (Announced) Parkway Cosmetic and Dental Spa (Private Dental Practice) Inspection date: 25 July 2016 Publication date: 26 October 2016 1 This publication and other HIW

More information

Patient Group Directions Policy

Patient Group Directions Policy Patient Group Directions Policy Category: Summary: Equality Analysis undertaken: Valid From: Date of Next Review: Approval Date/ Via: Distribution: Related Documents: Author(s): Further Information: This

More information

Assessment of Mental Capacity and Best Interest Decisions

Assessment of Mental Capacity and Best Interest Decisions Standard Operating Procedure 1 (SOP 1) Assessment of Mental Capacity and Best Interest Decisions Why we have a procedure? This Standard Operating Procedure (SOP) is required to set out how a person s capacity

More information