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