Clinical Research Induction Pack for Nurses, Midwives and other Allied Health Professionals

Transcription

1 Clinical Research Induction Pack for Nurses, Midwives and other Allied Health Professionals Leeds Teaching Hospitals NHS Trust & University of Leeds Name... Job Title... Start Date... Line Manager... 1

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3 CONTENTS Page No Glossary and Further Resources - 4 Introduction - 12 Useful contacts - 13 SECTION A INDUCTION Clinical Research Nurse Induction programme - 15 o Local research induction - 18 o Induction Programme line manager sign off - 20 o Clinical Research Nurse Competency Tool - 21 SECTION B ESSENTIAL KNOWLEDGE Research & the NHS - 59 o LTHT R&I Strategy - 60 National Institute of Health Research and the Networks - 65 Research Governance - 68 o Declaration of Helsinki - 70 o Good Clinical Practice - 71 o Health Research Authority & Ethics - 73 o EU Directives, Statutory Instruments and MHRA - 74 o Roles & Responsibilities of Researchers & Organisations - 75 o Amendments - 79 o Safety - 83 o Human Tissue Act - 84 o Data Protection - 85 o Informed Consent - 86 o SOPs Standard Operating Procedures - 88 SOP training log & SOP template Trial design - 92 Case Report Forms - 94 Essential Documents - 96 Appendices I Clinical Research Forum Terms of References II Training Folder Template III Research CV template Authors: E. Giddings/D. Beirne Date of Review: March

4 AE Adverse Event GLOSSARY ABPI ARSAC CF CI Clinical Trial CRN Clinical Trial Regulations Clinical Trial Authorisation Clinical Trial of an Investigational Medicinal Product (CTIMP) Cohort Community-based Clinical Trial Complementary and Alternative Therapy Confidentiality Regarding Trial Participants Contraindication Control Group CRA Association of the British Pharmaceutical Industry Administration of Radioactive Substances Advisory Committee Consent Form Chief Investigator A clinical trial is a research study designed to methodologically answer specific questions about novel therapies, treatment techniques or new ways of using known treatment. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Clinical Research Nurse The Medicines for Human Use (Clinical Trials) Regulations 2004 The authorisation from the MHRA as Competent Authority, in the UK to conduct a clinical trial of an investigational medicinal product (CTIMP). Is any investigation in human subjects, other than non-investigational trial, intended to a) discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products; b) to identify any adverse reactions to one or more such products or c) to study absorption, distribution, metabolism and excretion of one or more such products with the object of ascertaining the safety or efficacy of those products. In epidemiology, a group of individuals with some characteristics in common. A method of providing experimental therapeutics prior to final approval for use in humans, this procedure is used with very sick individuals who have no other treatment options. Often approval is on a case-by-case basis. Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or treat health conditions. Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants consent to the use of their records for data verification purposes should be obtained prior to the trial and assurance must be given that confidentiality will be maintained. A specific circumstance when the use of certain treatments could be harmful. The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo (See Placebo and Standard Treatment). Clinical Research Associate (Monitor) 4

5 CRF CRO CRUK CTA CTC DMC Data Safety and Monitoring Board (DSMB) Diagnostic Trials Dose-ranging Study Double-blind Study Drug-Drug Interaction ECMC Efficacy Eligibility Criteria EMEA EORTC Case Report Form Contract Research Organisation Cancer Research UK Clinical Trials Authorisation Common Toxicity Criteria Data Monitoring Committee An independent committee composed of community representatives and clinical research experts that review data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved. Refers to trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or illness being studied. A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful. A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving the placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participants about the experimental drug do not affect the outcome (See Blind, Single-Blind Study and Placebo). A modification of the effect of a drug when administered with another drug, the effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug. Experimental Cancer Medicines Centre The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. Summary criteria for participant selected; includes inclusion and exclusion criteria (See Inclusion and Exclusion Criteria). European Medicines Evaluation Agency European Organisation for Research and Treatment of Cancer 5

6 EU Directive EudraCT Expanded Access Food and Drug Administration (FDA) GCP GLP GMP Health Research Authority Hypothesis Inclusion/Exclusion Criteria Informed Consent Informed Consent Document ICH GCP ICR Investigational Medicinal Product (IMP) Directive 2001/20 EC of the European Parliament and the Council of the European Union relating to the implementation of good clinical practice in the conduct of the clinical trials of medicinal products for human use. European Drug Regulation authorities in Clinical Trials Refers to the distribution of experimental drugs to participants who are failing on currently available treatments for their condition and who are also unable to participate in ongoing clinical trials. The US Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines and medical devices, including those used in the diagnosis, treatment and prevention of HIV infection, AIDS and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the US national blood supply. Good Clinical Practice Good Laboratory Practice Good Manufacturing Practice The HRA works closely with the MHRA and NIHR creating a unified approval process and to promote proportionate standards for compliance and inspection within a consistent national system of research governance A supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation. The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial, these criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants and keep them safe. The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the whole of the study to provide information to participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract and the participant may be withdrawn from the trial at any time. International Conference on Harmonisation Good Clinical Practice Institute of Clinical Research A pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorisation but is, for the purposes of the trial: a) Used to assembled (formulated or packaged) in a way different from the form of the product authorised under the authorisation; b) Used for an indication not included in the summary of product characteristics under 6

7 the authorisation for that product; c) Used to gain further information about the form of that product as authorised under the authorisation. Investigator s Brochure (IB) IRAS IRMER KSF Lead Site Medicines and Healthcare products Regulatory Agency (MHRA) NHS NIGB NIHR NIHR CSP National Research Ethics Centre Open Label Trial Peer Review PIS PPI Pharmacokinetics Placebo Placebo Controlled Study A document containing a summary of the clinical and non-clinical data relating to an investigational medicinal product which are relevant to the study of the product in human subjects. Integrated Research Application System Ionising Radiation Medical Exposure Regulations Knowledge and Skills Framework In the case of a multi-site study, the site for which the Chief Investigator is also the Principal Investigator. Is the competent authority for the UK in relation to the EU Directive and the Clinical Trials Regulations. MHRA (Devices) is the competent authority for the UK in relation to the Medical Devices Regulations National Health Service National Information Governance Board National Institute of Health Research NIHR Coordinated System for gaining NHS permission Directorate within the National Patient Safety Agency that provides help and leadership for RECs by co-ordinating the development of operational and infrastructure arrangements in support of their work. This includes implementing standards to ensure national consistency, providing training for REC members and Co-ordinators, identifying IT solutions for procedural management and establishing regional REC centres to manage RECs. A clinical trial in which doctors and participants know which drug or treatment is being administrated. Review of a clinical trial by experts chosen by the study sponsors. These experts review the trial for scientific merit, participant safety and ethical considerations. Participant information sheet Patient and public involvement The process of absorption, distribution, metabolism and excretion of a drug or vaccine. A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatments effectiveness. A method of investigation of drugs in which an inactive substance is given to one group of participants, while the drug that is being tested is given to another group. The results 7

8 obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition. Principal Investigator (PI) Protocol Quality of Life Trials Randomisation Randomised Trial R&D REC Serious Adverse Event (SAE) Single Blind Site Specific Assessment (SSA) SOP Sponsor Standard Treatment Statistical significance Serious Adverse Reaction (SAR) The investigator responsible for the research site where the study involves specified procedures requiring site-specific assessment. There should be one PI for each research site. In the case of a single-site study, the CI and the PI will normally be the same person. A document that describes the objectives, design, methodology, statistical considerations (or other methods of data analysis) and organisation of a research study. Refers to trials that explore ways to improve comfort and quality of life for individual s chronic illness. A method by which study participants are assigned to a treatment group. Randomisation minimises the differences among groups by equally distributing people among the trial arms. A study in which participants are randomly assigned to one of two or more treatment arms of a clinical trial. Research and Development Research Ethics Committee Serious adverse event, an untoward occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity or consists of a congenital anomaly or birth defect. A study in which one party, either the investigator or participant is unaware of what medication the participant is taking. An assessment of the suitability of the investigator, site and facilities made for any study with a Principal Investigator at each research site. The application for SSA should be made by the Principal Investigator using the Site-Specific Information (SSI) Form. In the case of a multi-site study, the outcome of the SSA should be notified to the main REC within 25 days. Standard Operating Procedure The person who takes on ultimate responsibility for the initiation, management and financing (or arranging the financing) of a clinical trial. A treatment currently approved, in wide use and considered to be effective in the treatment of a specific disease or condition. The probability that an event or difference occurred by chance or alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed. A serious adverse reaction in a CTIMP that results in death; is life-threatening; requires hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability or incapacity; or consists of a congenital anomaly or birth defect. 8

9 Suspected Unexpected Serious Adverse Reaction (SUSAR) TMF TSF UKCRC A SUSAR is a CTIMP which is unexpected, meaning that its nature and severity are not consistent with the information about the medicinal product in question set out: a) In the case of a product with a marketing authorisation, in the summary of product characteristics for that product; b) In the case of any other investigational medicinal product, in the investigator s brochure relating to the trial in question. Trial Master File Trial Site File United Kingdom Clinical Research Collaboration Acknowledgements: The following were members of the Clinical Research Induction Working Group: Debbie Beirne, Emma Giddings, Viv Dolby, Suzanne Rogerson, Cancer Research UK Nurse Consultant & Assistant Director of Clinical Research, LTHT Lead Nurse, West Yorkshire CLRN Senior Midwife Researcher, LTHT Senior Research Nurse, LTHT This document has been based on the Yorkshire Cancer Research Network s Induction Pack and includes submissions from the following: Neville Young QA Manager, Research & Development Dept LTHT 9

10 Further resources: NIHR Clinical Research Network NIHR Clinical Research Portfolio Search the NIHR portfolio database Primary Care Research Network (PCRN) Mental Health Research Network: Dementias and Neurodegenerative Diseases Research Network Diabetes Research Network National Cancer Research Network Yorkshire Cancer Research Network Yorkshire Stroke Network Yorkshire Cancer Network MHRA Clinical Trials Toolkit IRAS (Integrated Research Application System) yorkshire.uksrn.ac.uk

11 Further Reading: Plan for Growth Liberating the NHS, Equity and Excellence _ The Strategy for UK Life Sciences BMK_Spreads.pdf A "prospectus" entitled Investing in UK Health and Life Sciences The NHS Chief Executive's review: Innovation Health and Wealth - Accelerating Adoption and Diffusion Developing the Role of the Clinical Academic Researcher in the Nursing, Midwifery and Allied Health Professionals Competency Framework for Clinical Research Nurses ts/competencies 11

12 Introduction Welcome to your post in clinical research. The health research arena in LTHT and The University of Leeds is a dynamic and diverse one in which multiple disciplines and professions work collegiately and in partnership to deliver world class research for patient benefit. There are strong and established areas of research activity in Oncology, Muscular-skeletal medicine and cardiovascular research, but also many more in surgery, general medicine, paediatrics and midwifery to name but a few. There is a wealth of research ongoing across the University and Trust in epidemiology, genetics, psychology and many other areas of health science. You are therefore joining a team of colleagues who desire to improve the health outcomes for patients and the public by means of effective prevention, earlier detection, improved diagnostic markers, enhanced treatment techniques and novel therapeutics; drives their professional focus and commitment to delivering high quality, robustly evidenced health research. Starting in a new role in research can be daunting, and you may find that whatever prior experience you come with does not seem of use, or where you once felt competent you now feel a novice again. This is a common experience for many and it is important to remind yourself that your skills and knowledge are extremely valuable to this role, but that there is much also to learn and new skills to develop and allow yourself the time to do so without undue pressure. A career in health related clinical research can be personally, intellectually and professionally very rewarding. At the heart of a research nurse or allied professional role is patient care and advocacy. Research involving unlicensed medicinal products, invasive interventional studies and early phase clinical trials can be particularly challenging to deliver and therefore require research staff to be flexible, innovative, proactive and committed to successfully recruit and safely care for patients, and deliver the quality data required to inform and influence future practice. We hope you find the information and guidance in this handbook a useful first reference point in your induction and start of your research career. Do not struggle in your new role but seek the support and advice of the R&D department and other research colleagues. A list of key contacts is included in this handbook. Wishing you every success in your post Debbie Beirne Nurse Consultant for Clinical Research Leeds Teaching Hospitals NHS Trust Emma Giddings Lead Nurse West Yorkshire CLRN 12

13 Useful Contacts Research & Development Department 34 Hyde Terrace Leeds LS2 9LN T F E r&d@leedsth.nhs.uk Debbie Beirne Cancer Research UK Nurse Consultant & Assistant Director of Clinical Research Oncology Research Department Level 6, Bexley Wing St James s University Hospital T E d.a.beirne@leeds.ac.uk Deborah.beirne@leedsth.nhs.uk West Yorkshire Comprehensive Local Research Network Leeds Innovation Hub 103 Clarendon Road Leeds LS2 9DF Emma Giddings Lead Nurse T F M E E.K.Giddings@wyclrn.org.uk Visit the WYCLRN Website: 13

14 SECTION A Clinical Research Nurse Induction Programme Local Research Induction Line Management Induction Programme Sign Off Clinical Research Nurse Competency Tool 14

15 CLINICAL RESEARCH NURSE INDUCTION PROGRAMME This Induction Pack forms part of the Clinical Research Nurse Induction Programme and includes guidance to ensure that you and your line manager can: Plan a comprehensive induction programme, Gain an understanding of the core skills and knowledge needed to work in research; Review the competencies and complete the Clinical Research Nurse Competency Tool, to set learning objectives and identify training opportunities. As a Clinical Research Nurse you will be providing specialist care that will have a potential benefit to your patients as well as a benefit to future patients. The role of a Clinical Research Nurse is diverse, covers many specialties and is increasingly becoming recognised as a specialty in its own right. It can be a challenging role but is an opportunity to use the skills you have gained in clinical practice, combined with new research skills that you will acquire that will establish your career as a Clinical Research Nurse. You will be responsible for ensuring that your clinical trials are completed according to the study protocol, that you perform any tasks which are delegated to you and that you have sufficient experience and training to complete these tasks. The most important elements of your role will be to provide a high standard of care and ensure patient safety and to collect good quality data. The safety of your patients remains as important as it would in a non-research role and poor data quality can affect the quality of the entire study. This induction Pack is designed to give you the information you need at the outset. It aims to be a comprehensive resource which you can refer back to throughout your career. It will form a foundation to your learning and give you the opportunity to reflect upon this and signpost you to external resources of further information, as your knowledge increases. Training In order to achieve your goals of patient safety and data quality and to adhere to legislative requirements and research governance guidelines you will be required to complete Good Clinical Practice (GCP) training. GCP training is mandatory for anyone working in clinical research. If you have not completed GCP training before this is something that you will need to undertake as a priority during the first month in post. GCP training can be undertaken as an online course or a full day classroombased course (NIHR Introduction to GCP) available several times per year within the Trust, University of Leeds and through WYCLRN. Both ways have pros and cons but you may find it helpful to complete an online course (which usually takes 3-4 hours) as soon as you can, followed by a full day course within the first six months in post. 15

16 West Yorkshire CLRN offer a programme of training courses for clinical research nurses who are new to research. This consists of 3 separate full day courses: Introduction to GCP Informed Consent Introduction to Clinical Research Details of these courses funded by the WYCLRN can be found on their website: us/ccrn/west yorks/news/training The Trust s R&D Department also offer shorter Informed Consent workshops that are mandatory for any Trust employees who are involved in obtaining consent for clinical trials. The sessions take about an hour and delegates receive a certificate in Informed Consent at the end. Dates for forthcoming workshops can be found on their website: The National Cancer Research Network has a training curriculum which can be viewed on and can sometimes be accessed by non-oncology researchers. To record your professional development and to support the duties you are undertaking within your studies it will be useful to set up a Training Folder (recommended inserts can be found in Appendix II). This will demonstrate the experience you gain and training you complete as you progress through your career. This should include a research CV (see appendix III) as well as copies of your GCP Certificate and Informed Consent certificates as well as a copy of your job description. Equipment The equipment and resources that you will need to work in research will vary depending on the type of studies you are involved in and whether or not research is new to your area or already established. However, here is a suggestion of what you may find useful: Desk, chair, PC, telephone Fax machine (or access to a secure one) Diary Files to store any paper based data Notebook and other general stationery items Lockable filing cabinet(s) 16

17 Access to or use of: Centrifuge (with training on safe use of this equipment) Fridge Freezer Lab space Photocopier Building Networks It is important that you feel supported within your role and we recommend that you make the most of any opportunities to network with other research colleagues. The Clinical Research Forum at Leeds is open to all nurses and allied clinical trial personnel involved in research. The Forum meets quarterly and is supported by the R&D Department. This is a great opportunity to meet other research professionals to network, share ideas and problems, facilitate good practice across the group and keep up to date with national initiatives. (see appendix I) It is imperative that wherever possible research nurses or AHPs do not work in isolation. If you are a lone worker in a particular area, please seek support and guidance from other experienced research colleagues in other specialties. The R&D department and the Lead Nurse at WYCLRN can offer further information. 17

18 Induction It is important that you meet with your Line Manager to discuss the scope of your role, your previous experience and ensure your Induction Programme covers all aspects of your role. Your Induction Programme should include the following: Familiarisation with working areas and induction into the building(s) as appropriate Fire and evacuation procedures (attend Trust mandatory Fire Awareness Training) Trust induction programme if new to LTHT/University of Leeds ID badge and access procurement Absence policy and arranging of annual leave Clear understanding of line management and reporting Information gathering around specialty area of practice, advice on key learning and sources of appropriate information/courses Allocation of a mentor or buddy for supervision and guidance Familiarisation with data protection legislation and institutional policies Internal governance procedures and quality assurance Understanding the roles of RECs and R&D, and the statutory legislation for research governance Understanding of research methods How to describe randomisation and equipoise to potential subjects Other trial related procedures, clinical and non-clinical Introduction to multi-disciplinary team and attendance at MDT meetings where appropriate Shadowing colleagues in clinical areas and for peer learning re research trial conduct Introduction to blood sampling handling, processing, shipment Dry ice handling and legislation/guidance Familiarisation with departmental SOPs Introduction to electronic information management systems Participate in a monitoring visit Pathway Co-ordinators (oncology) Introduction to key staff: Relevant consultants and wider medical team Matron (or appropriate AHP line manager) Directorate manager/faculty or R&D lead at University R&D lead for specialty Business Manager Nursing and other local research colleagues Outpatient or other patient areas to be utilised when conducting research Administrative team and or wider research support staff as appropriate/available to your area 18

19 Clinical Research Induction Pack for Nurses, Midwives and other Allied Health Professionals Leeds Teaching Hospitals NHS Trust/University of Leeds Example Induction Programme Mon Tues Wed Thurs Fri Week 1 Corporate Induction full day Introduction to Research Team Local induction with line manager Meeting with PI Meet with O/P Clinic Sister Visit by study monitor Meet with Lead Nurse WYCLRN Spend time with Clinical Trials Pharmacist Study training with research nurse Week 2 Shadow Research Nurse in clinic NIHR Introduction to GCP training Attend new patient clinic OPD Meet with CNS am Shadow Research Nurse in clinic Attend Clinical Research Forum 12pm Week 3 Lab training Visit R&D Dept Attend Informed Consent Training Shadow Research Nurse in clinic Attend Inpatient Service Team Meeting Week 4 Attend Directorate Sisters meeting Study training with research nurse SOP training with line manager 16 March 2012 version 1.1 Authors: E. Giddings, D. Beirne

20 Clinical Research Induction Pack for Nurses, Midwives and other Allied Health Professionals Leeds Teaching Hospitals NHS Trust/University of Leeds Line Management Induction Programme Sign Off Local Induction completed Date: Month 1 Induction Programme confirmed* Date: Competency Tool (Induction) reviewed and objectives set Date: Competency Tool (6 months) reviewed and objectives set Date: Competency Tool (12 months) reviewed and objectives set Date: Signature: Date: (Line Manager) Signature: Date: (Research Nurse) *It is your responsibility as well as your manager s to ensure that you have a comprehensive Induction Programme for the first month in post. This will be defined by the department you are based in and your previous experience and therefore will need to be developed as part of your review. 16 March 2012 version 1.1 Authors: E. Giddings, D. Beirne

21 Clinical Research Nurse Competency Tool: Purpose of this document: This document has been developed to be a working tool for Clinical Research Nurses (CRNs) and their line managers to assess and review CRN competencies and is based directly on the Competency Framework for Clinical Research Nurses, A tool to promote patient safety and quality data (October 2011). Competencies are the essential skills and knowledge required by nurses to carry out their work in a safe and effective way. The competencies within this document have been identified as those unique to the role of a Clinical Research Nurse and are intended to provide clear guidance on the scope of this role and define the differences between bands 5 through to 8. How to use this document: This document forms part of the Clinical Research Nurse Induction Programme for LTHT. During the first month in post the Clinical Research Nurse and their Line Manager should review the competencies together. The worksheets titled Induction should be used to review the CRN competencies and should be used to identify personal objectives together with any training needs to form part of the CRN s developmental plan. It is recommended that a review of the competencies is conducted at 6 months and again at 12 months using the review worksheets. The higher level of assessment target at 12 months demonstrates the level of knowledge and skills acquisition that should have occurred during the first 12 months in post. What is a competency? The Competency Framework for Clinical Research Nurses defines competency as: the ability to demonstrate the application of knowledge, understanding, practical and thinking skills to achieve effective performance in a professional or occupational role. This involves problem solving and being sufficiently flexible to meet changing demands. Further details on the use of competencies can be found in the Competency Framework. 21

22 The competencies Competence 1 To demonstrate understanding of the background, political influence and strategy regarding clinical research in the UK Competence 2 To work within, and adhere to, the requirements of research ethics, research governance and legislation 2.1 Understands the role and remit of research ethics committees in the UK 2.2 Contributes to the preparation of documentation and submissions of applications for ethical approval Competence 3 To understand, apply and promote the principles and practice of obtaining valid informed consent Competence 4 To apply professional knowledge and skills to facilitate efficient, safe and participants focused clinical research 4.1 Contributes to the development of safe clinical research 4.2 Contributes to efficient use of resources 4.3 Contributes to the delivery of clinical research 4.4 Contributes to the safe collection and storage of data and accurate completion of study documentation 22

23 Competence 1: To demonstrate understanding of the historical background, political influence and strategy regarding clinical research in the UK Skills and behaviours Knowledge and understanding KSF Understands the relevance of the historical development of clinical research to current research and policy. Understands the current political context and relevant policy. Champions the role of clinical research to the development of health, social care and the wealth of the nation. Supporting and influencing the embedding of clinical research in NHS infrastructure / practice. History of ethics related to clinical research [2-18]. Development of research ethics and governance [19-23]. Methodological developments in clinical research [24-27]. Political and strategic developments in clinical research [19, 28-34]. C1 C2 C3 C5 G5 Examples: Band 5 Band 6 Band 7 Band 8 Recognises the importance of acknowledging the historical context within which clinical research is undertaken. Articulates the significance of major historical events, publications and policy developments in the evolution of clinical research, including political imperatives and government strategies. Demonstrates comprehensive knowledge and understanding of the historical context, political influence and strategic developments relating to the evolution of clinical research. Takes a leading role in supporting understanding of the historical and political context in which clinical research has developed and is currently being undertaken. 23

24 Competence 2: To work within the regulations framework 2.1 Understands the role and remit of research ethics committees in the UK Skills and behaviours Knowledge and understanding KSF Recognises the need to ensure that appropriate ethical opinions and governance approvals are obtained before any research activities are undertaken. Articulates understanding of regulatory requirements. Undertakes relevant educational activities [35-40]. Structure and policy for the regulation of research [41-42]. Roles and responsibilities of RECs [19, 31-32, 43-47]. Structure and organisation of RECs and their membership [19, 41-44]. Structure and organisation of R&D Departments, their membership and their roles and responsibilities [31-32]. Processes for the submission of applications and their review [19, 29, 43-44, 46, 48-51]. Local policies and procedures related to ethical review and research governance [29, 31-32, 48]. Local and national policy developments [52-54]. Roles and responsibilities of investigators and other members of the research team [31-32]. Knowledge of procedures when breaches of protocol are identified or when fraud and misconduct is suspected [29, 39, 46, 48-49]. Actions required when processes to protect participant confidentiality are not followed. C1 C2 C3 C5 G5 Examples: Band 5 Understands the need for favourable ethical opinion and research and governance approval to be obtained before commencing research activities. Has an awareness of the structure, roles and function of RECs and R&D Departments. Knows how to raise concerns and report instances of protocol deviation. Band 6 Contributes to the development of research protocols. Has knowledge and understanding of structure, roles and function of RECs and R&D Departs. Has Knowledge of local R&D policies and procedures. Has familiarity with regulatory requirements. Act as a knowledgeable resource and advisor to staff and researchers. Contributes to supervision and meeting educational needs of staff. Band 7 Provides comprehensive advice and guidance on matters relating to research ethics and governance. Act as a resource to staff & contributes to the professional & educational development of staff. Leads on the development and updating of local policies and procedures. Leads on the professional and educational development of staff. Band 8 Demonstrates leadership by: Act as an expert resource to staff and researchers. Leading on the professional and educational development of staff. Ensuring appropriate reporting at the organisation executive board level. 24

25 Competence 2: To work within the regulations framework 2.2 Contributes to the preparation of submissions for regulatory reviews Skills and behaviours Knowledge and understanding KSF Aware of application processes and requirements for document management. Leads or contributes to the preparation of paperwork and submission of applications. REC and R&D application processes (IRAS) [19, 44, 55-57]. Other centralised permissions [58]. Key documentation required to support REC and R&D submissions [19, 56]. Protocol development. Local review and reporting of research studies [59]. Clinical Research Agreements [60-61]. Risk assessment and feasibility. Local and national policy developments. Research sponsorship and researcher roles [31-32, 48, 56]. Professional responsibilities and potential for conflict with research role [62]. C1 C2 C3 C5 G5 HWB2 Examples: Band 5 Band 6 Band 7 Band 8 Articulates the importance of clear, complete and accurate submissions. Familiar with application processes. Act as a knowledgeable resource for staff and researchers making applications for regulatory approvals. Raises concerns and seeks to address incomplete, inaccurate or misleading documentation. Contributes to supervision and meeting the educational needs of staff. Act as expert resource for staff and researchers preparing submissions for regulatory approval. Prepares, or makes significant contribution to the preparation of applications for regulatory approval. Contributes to the professional and educational development of staff and researchers. Ensuring that all processes, policies and standard operating procedures are in place. Contributing to quality assurance. Leading and taking responsibility for research in position of PI or CI. 25

26 Competence 3: To understand, apply and promote the principles and practice of obtaining and maintaining valid informed consent Skills and behaviours Knowledge and understanding KSF Assures the provision of an environment conducive to obtaining valid informed consent. Contributes to policy and practice development. Aware of and is responsive to factors contributing to decision making during the consent process. Assures patient safety by proactively managing any breaches of the informed consent process. Principles of informed consent for participation in research [18, 63-65]. Roles of researchers, including CI and PI, in gaining and maintaining informed consent [31-32]. Role of research nurses [31-32, 40, 66-69]. Role of the REC [19, 42-43, 70-71]. Key information required in PIS and CF [19, 72-75]. Ongoing nature of informed consent. Legal requirements related to gaining and maintaining valid informed consent, especially when participants lack capacity [76-80]. Local policies and procedures relating to gaining and maintaining valid informed consent. C1 C2 C3 C4 C5 C6 HWB2 HWB3 Band 5 Effectively engages with research participants to ensure understanding of info about the research. Demonstrates an awareness of the factors contributing to a participant s autonomous decision making during the consent process. Complies with the informed consent processes as described in the approved protocol, including use of approved versions of PIS and CF. Raises any concerns about the informed consent processes. Recognises own learning needs and takes responsibility for maintaining up to date knowledge. Provides evidence of training and understanding. Recognises that informed consent is an ongoing process. Band 6 Demonstrates a sound understanding of the need to identify issues which may impact on the process of gaining valid informed consent. Plans and implements actions to resolve these issues. Receives informed consent when appropriate and as agreed in the approved protocol. Supports participants through the consent process. Band 7 Act as an expert resource to provide in-depth knowledge to acquire and maintain informed consent. Contributes to the mentorship and monitoring of consent procedures. Responsible for the reporting of poor consent processes that compromise patient safety and the study protocol. Band 8 Demonstrates leadership by: Attending and reporting to corporate boards regarding governance, policy and service development related to research. Holding responsibility for the training and monitoring of correct consent processes in research. Developing systems to ensure that correct procedures are adhered to. Contributing to professional development and education of clinical research staff in the organisation. 26

27 Competence 4: To apply professional knowledge and skills to facilitate efficient, safe and participant focused clinical research 4.1 Contribute to the development and facilitation of clinical research Skills and behaviours Knowledge and understanding KSF Has an understanding of the research designs and methodologies used in clinical research. Understands the implications for practice of the regulatory and legal frameworks related to the planning, delivery and closure of clinical research studies. Has a comprehensive knowledge and understanding of the regulatory and legal frameworks related to the planning, undertaking and closure of clinical research studies. Encourage, appreciate and value the contribution of study participants in all areas of research activity. The role of the National Institute of Health Research (NIHR) [48, 52, 81]. The need for Quality Assurance [82-83]. Phases of clinical research [84-85]. Different research study designs: including protocol design and development; sample size and power; inclusion and exclusion criteria; randomisation; blinding and unblinding [49, 81, 86-88]. Translational research [89-90]. Multi-centre studies. Management processes from feasibility to closure [49, 91] Pharmacovigilance [92-93]. Local, national and international dissemination of clinical research findings [94-97]. Relevant UK legislation [76, ]. Professional codes of practice [62]. Roles of licensing authorities and the licensing of investigational products [29, ]. Local requirements, policies and procedures. C1 C2 C3 C5 G

28 Examples: Band 5 Band 6 Band 7 Band 8 Consistently adheres to the study protocol design. Raises concerns if design conflicts with regulatory frameworks and legal requirements or if research activities deviate from the study protocol. Recognises own limitations and attends/completes relevant training (including GCP). Is supportive in the training of others. Demonstrates an awareness of the need for patient and public involvement (PPI) in clinical research. This could include their involvement in any aspect of the research process. Act as a knowledgeable resource for staff, researchers, research participants and patients. Contributes to the training and supervision of staff and researchers. Contributes to the development of local policies related to all parts of the clinical research process. Promotes and facilitates PPI in all aspects of clinical research. Contributes to nurse led research. Act as an expert resource for staff, researchers, research participants and patients. Demonstrates a detailed knowledge and understanding of different research designs and methodologies and the regulatory and legal frameworks related to clinical research studies. Leads on the training and ensuring the appropriate supervision of staff. Leading role in the development and updating of local policies and procedures. Contributes to the development of national policies and procedures. Leads in planning, conducting and supervising nurse led research. Demonstrates leadership by: Playing an integral role in R&D for a, (locally, nationally and internationally). Contributing strategically on all areas of clinical research. Political astuteness. Professional leadership. Efficient and effective networking skills. Further development of clinical research. Prioritising competing needs. Contributing to the professional development and education of clinical research staff and organisations. Contributing to or leading clinical research

29 4.2 Contribute to effective and efficient use of resources Skills and behaviours Knowledge and understanding KSF Has an awareness of the financial issues related to the planning and conducting of clinical research. Recognises their role and contribution to the local and national strategic vision. Funding of research studies [106]. Financial agreements [60-61]. Financial management during the course of a clinical research study [91]. Identification of costs [107]. Role of the research funder [31-32]. National and local research costing models. Local employment policies and models of working. C2 G5 Examples: Band 5 Band 6 Band 7 Band 8 Consistently operates within the financial constraints of the funding available for a clinical research study. Alerts relevant personnel to potential escalating consumable and other costs associated with a clinical research study. Is aware of different staff roles and responsibilities regarding resources. Contributes to the financial processes of planning, running and closing clinical research studies. Involved in the financial processes associated with coordinating research studies and grant applications. Act as an expert resource for staff in relation to the financial management of clinical research studies. Uses expert judgment in relation to competing demands for funding. Involved in the management of staff as a resource. Demonstrates leadership by: Building alliances and working partnerships. Enhancing Institutional reputation Skill mix review. Contributing to the professional development of the workforce. Contributing to the acquisition of grant income and identification of other potential funding streams. Cost recovery systems. 29

30 4.3 Facilitate the delivery of clinical research Skills and behaviours Knowledge and understanding KSF Contributes to the delivery of clinical research protocols as a member of the research team. Understands the rationale behind adherence to ethical approved study protocols. Demonstrates safe and effective care of patients and/or research participants in research. Awareness of policies relating to Investigational Medicinal Products (IMP). Recognise the importance of accurate and comprehensive source documentation. Demonstrate a good understanding of GCP in relation to direct patient/participant care. Local Medicines Policy. Quality Assurance [82]. Standard Operating Procedures (SOPs) [108]. Relevant clinical skills in line with local procedures and national occupational standards [31-32]. Knowledge of research study protocol. Processes for participant recruitment. Risk Management. Public involvement in research [87]. Importance of submitting recruitment figures to relevant bodies, including NIHR recruitment data [29, 52]. Local organisational policies and procedures. C1 C2 C3 C5 Ik2 G5 G6 Band 5 Band 6 Band 7 Band 8 Is able to correctly use and dispose of study supplies and equipment, in accordance with study protocol and relevant Standard Operating Procedures (SOPs). Completes accurate paperwork associated with research study supplies. Attends relevant training in relation to requirements of research study protocol. Consistent application of relevant clinical and research skills. Contributes to an active and effective research culture. Actively involved in the ordering of supplies, ensuring that resources (including staff and beds) are available for the effective conduct of the research study. Ensures clear and accurate documentation is maintained on the arrival, use and disposal of research study supplies. Advises staff and researchers, acting as a knowledgeable resource on matters relating to clinical practice and research, promoting an active and effective research culture. Contributes to the development and training of staff and researchers. Contributes to the development of SOPs. Takes a leading role in managing research studies. Supports colleagues and researchers through the research study process, including clinical aspects associated with the research study. Takes the lead on developing and updating SOPs. Takes a leading role in activities of professional fora and networks. Contribute to local recruitment strategies. Demonstrates leadership by: Having wider oversight and strategic vision. Actively seeking to collaborate and share best practice to enhance delivery of clinical research. Promoting effective recruitment strategies to increase recruitment in line with local/national targets. 30