COMPETENCY FRAMEWORK

Transcription

1 COMPETENCY FRAMEWORK Theresa Ledger Lead Nurse Research and Development Clinical Research Facility Sheffield C:\Documents and Settings\Robertus\My Documents\Mariann\CRF\CRF Portfolio and Competency Template_DRAFT Final2.doc Page 1 of 69

2 COMPETENCY FRAMEWORK Introduction The Clinical Research Facility (CRF) competency framework has been developed to build on the work completed by the Study Site Coordinator (SSC) Executive Group on behalf of the Sheffield Teaching Hospitals NHS Foundation Trust Research Department. It is specifically aimed to develop research nurses enabling them to gain the knowledge and skills necessary to work effectively within the clinical research arena, equipping the individual to practice either within the CRF or as an outreach practitioner. Background The SSC executive was set up to address the issues relating to employment, recruitment, retention, education and professional opportunities for research nurses at STH. It is acknowledged the pivotal role that research nurses played in the good conduct of clinical research in comparison with a lack of recognition of their expertise and value to the Trust. The importance of the work of the group has been recognised by the Chief Nurse. The Clinical Research Facility is a unit specifically dedicated to the conduct of clinical research. It provides a centralised source of specialist staff, space and equipment to support all types of clinical research ranging from large studies funded by the pharmaceutical industry and grant awards to investigator initiated proof of concept or feasibility studies. The CRF strives to ensure all research taking place is completed to the highest possible standard, ensuring compliance with all applicable legislation and STH policies and procedures. Rationale The competency framework has been developed to support research nurses achieving the optimum level of competence to function safely and confidently in the role. To be a competent practitioner research nurses must achieve an identified level of skills and knowledge for the role. Page 2 of 69

3 Using the CRF Competency Framework The competencies incorporated in the framework indicate the expected route for the development of the individual as a clinical research nurse. It provides the opportunity for the research nurse to document their progress and provide evidence of achievement as well as the opportunity to reflect how they are applying their theoretical knowledge in practice. The framework should be used flexibly to reflect the different existing skills of the individual practitioner and is not aimed entirely at those new to the role but should be used by more experienced practitioners to identify gaps in their knowledge and skills or to move forward towards achieving expert practitioner level. The framework is not exhaustive and can be revised to meet changes to research legislation and practice and for the addition of practical study specific competencies. The Competency Framework develops the research nurse from novice to advanced practitioner in individual topics allowing the individual to plan their progression through the different levels. The framework has been developed to assist research nurses develop their Knowledge and Skills and aid progression through the career gateways as demonstrated in the Knowledge and Skills Framework and assist research nurses and their line managers identify when individuals have sufficient knowledge and skills to enable career progression in a more senior role. Therefore each competency begins at novice level and progresses to the competency expected of an advanced practioner. Categorisation Level Category Definition N Novice Requires Induction Limited knowledge and experience. Requires Theoretical knowledge Requires training and observation and supervision S Supported Possesses knowledge and experience Able to perform in area but requires guidance C Competent Knowledgeable and experienced within the role Able to assess situations identifying where additional support is required E Expert Expert practitioner uses knowledge, skills and experience to provide optimal service AP Advanced Practitioner Leader in the field with advanced level knowledge and skills Page 3 of 69

4 Assessment The assessment of competency will be performed in partnership with an assigned mentor. Each research nurse is expected to assess their performance by evaluating their knowledge, skills and experience in each of the key competencies. Additionally your mentor will be responsible for confirming level of attainment and sign off at each level. The research nurse as they progress through the competency framework and the mentor will rank attainment according to the previously outlined categories. N, S, C, E and AP Expectation It is not the expectation that all research nurses will achieve the same level of competency in all of the research competencies identified in the framework, however it is the expectation that competency is achieved in all competencies that are relevant to their individual role. Additionally it is an expectation that in order to progress through the AfC Bands a -8b Competency is clearly demonstrated in all Research Competencies at the appropriate level. It should also be noted that the AfC Band 5 post is a training post unique to Sheffield and the CRF where full support, training and supervision are available. Level Category Definition N Novice Band 5 Training post and those Research Nurses new to post with no previous clinical research experience S Supported Band 5 training post following 12 months in post. Capable of moving onto Band 6 Research Sister Post Band 6 Research Sister Requires Induction Limited knowledge and experience. Requires Theoretical knowledge Requires training and observation and supervision Possesses knowledge and experience Able to perform in area but requires guidance C Competent Band 6 Research Sister competent to pass through final gateway. Band 7 Senior Research Sister Knowledgeable and experienced within the role Able to assess situations identifying where additional support is required Page 4 of 69

5 E AP Expert Band 7 Senior Research Sister competent to pass through final gateway. Band 8a Matron Advanced Practitioner Band 8a Matron competent to pass through final gateway STH NHS FOUNDATION TRUST Expert practitioner uses knowledge, skills and experience to provide optimal service Leader in the field with advanced level knowledge and skills Responsibilities The line manager must assign a mentor if they are not taking the role themselves. It is expected in the CRF that the line manager will in the majority of cases be the mentor for the team that they manage. The mentor must meet with the research nurse to carry out a preliminary assessment of their competency level before agreeing objectives and timescales for progression through the competency framework, planning regular assessment and review. It is also the responsibility of the mentor to ensure the research nurse has the necessary support and access to opportunities to enable skills and knowledge to develop. The research nurse must ensure they are actively engaged in objective setting; regularly updating their mentor on their progress identifying any areas where they may need additional support. Guidance notes are being developed to assist in the assessment of competency. Page 5 of 69

6 Demonstrating Competence There are a variety of ways each individual research nurse can demonstrate competency Evidence Direct Observation Simulation Testimony of others Discussion Reflection Project Management Documentation Teaching Assignments Education Work Product Presentations / publication Example Observing/shadowing other research nurses at competent, expert or advanced practitioner level Practical sessions providing the opportunity for individuals to practice competency demonstration in controlled supervised environment, EG CRF Workshops Verbal or written feedback from colleagues, investigators research participants and research sponsors,questioning competent, experts or advanced practitioners, Agendas and Minutes of meetings, Personal Professional Portfolio, Case Studies Project plans, pro-forma development, SOP writing, monitoring reports, data query response timelines, recruitment targets, site file, protocol review Letters, management, notes work books working files Copies of presentations given and evaluation of sessions Evidence from formal academic programmes Training log, objectives of courses study days attended, literature review, internet search Implementing change, Action following policy or legislative review, risk management, Producing SOPs, QA Tools National / international presentation / publication Page 6 of 69

7 Research Nurse Key Competencies Skill Level Summary Key competency skill level should be assessed by the individual and line manager. Level attained should be signed and dated by both individual and Line Manager Record to kept as part of Portfolio NAME: POSITION: Research Nurse Competencies Page 7 of 69

8 1. Protocol Review The Research Nurse can review, understand and implement and manage research protocols. 1.Knowledge Skills Level Evidence of Achievement Is aware of the Recognises a research protocol components of a research Can identify what are the core components of a protocol research protocol Understands the study design and phase of study Critically appraise the protocol and plan the project Possesses knowledge to fully operationalise and conduct a study protocol Comprehensive knowledge and understanding of all current clinical research projects Identifies the Research Question / Hypothesis Identifies and describes individual study designs Appropriately identifies the phase of the study Can describe the process of drug development and clinical trials With supervision: Reviews a protocol and prepares an operational plan Identifies key stages in planning the study Identifies knowledge gaps Project plans the study Manages communication across the MDT Can identify risks Can identify barriers to recruitment and protocol compliance Plans the conduct of multiple projects Prioritise projects across the portfolio Assigns staff to projects Initials and Page 8 of 69

9 2. Study Feasibility The Research Nurse can review and assess research proposals for feasibility identifying key elements for conduct and risk. Knowledge Skills Level Evidence of Achievement Is aware of the key points Identifies the need for feasibility review of necessary to assess projects feasibility of a research Gathers information for feasibility review proposal Can identify problems from a completed feasibility review Initials and Understands the risks involved in individual research proposals Understands the resource implications relating to individual research proposals Can identify risk in relation to: Participant Safety Entry criteria Protocol Compliance Study Timelines Finance CRF Staff/Environment Under supervision can identify resource needs in relation to: Project timescales PI / Dr input Research Nurse Room and space allocation Disposables Equipment Data management Sample management Risk management Page 9 of 69

10 Knowledge Skills Level Evidence of Achievement Uses full knowledge to Completes individual project feasibility to inform: Conduct feasibility review Finance Officer CRF Operational Team Identify resources Project Plan Knowledge of study drug Recruitment issues Data Capture Timelines Qualifications of Investigator and Team Suitability of facilities and equipment Training Monitoring arrangements Initials and Has full understanding of individual project feasibility when considered against all current clinical research projects Considers the feasibility of new projects against: Current portfolio of studies CRF staff complement CRF resource allocation Safety and risk in conjunction with CRF planned activity Page 10 of 69

11 3. Research Governance Authorisation The Research Nurse understands the process and can complete a full submission for authorisation Is aware of the key elements and background of Research Governance Framework Identifies the key factors instrumental to the introduction of the Research Governance Framework Can identify the key principles in the Framework Can identify key personnel at STH with governance responsibilities Understands the process locally for obtaining Research Governance Authorisation Understands the timescales involved to complete the authorisation process Describes the process at STH for gaining Research Governance Authorisation Can explain the steps in the flow chart for obtaining governance authorisation Can explain the governance role of the LCRN Under supervision: Completes a submission for STH Research Governance authorisation Plans the submission for governance authorisation Can predict realistic timescales in relation to protocol type Can work on several aspects of the submission in parallel Page 11 of 69

12 Comprehensive Plans several submissions in knowledge of submissions parallel Devises systems to track projects through the authorisation process to Uses in depth knowledge to support researchers making applications for Governance Authorisation aid CRF workload planning Liaises with research co-ordinators on complex authorisation issues Predicts which projects will pose authorisation problems and works with investigators to address these Provides expert advice Page 12 of 69

13 4. Project Costing The Research Nurse can identify full resource use for identification of project costs Knowledge Skills Level Evidence of Achievement Is aware of the CRF cost Can identify CRF/ Research Department system personnel involved in the costing process Completes CRF time allocation sheets weekly Provides information when requested to CRF Finance Officer/Research Accountant Initials and Can break down individual elements of a research protocol to assist the CRF Finance Officer identify and allocate accurate study budgets Understands the variety of funding sources available to NHS/Academic Researchers Can review a protocol and provide accurate breakdown of resources Disposables Equipment Space Visit Time Nursing time Investigator time Data management time Catering Patient expenses Unscheduled/additional visits Catering Out of hours arrangements Can explain the following: NHS R&D Funding UKCRN and portfolio funding LCRN funding and role Grant funding Page 13 of 69

14 Knowledge Skills Level Evidence of Achievement Commercial Funding Own/discretionary Funding Unfunded/pilot Initials and Comprehensive knowledge of Study budget Manages budget for portfolio of studies Can manage in liaison with Research Accountant the budget allocated to an individual study including monitoring payment and expenditure Can provide detailed costings Manages complete budget across a portfolio of studies to include all resources and staff Page 14 of 69

15 5. Ethics Submission The Research Nurse understands the ethics surrounding clinical research and can successfully submit to NRES Has an awareness of the Can explain the following: National Research Ethics The role of the NSPA Service and the roles of The role of NRES the various committees The remit of the different ethics Main, Local and committees Recognised - Main - Local - GTAC - Recognised - Phase 1 Is aware of the submission process to all of the above Understands the ethical implications of clinical research Knowledge of the historical context and development of the ethical principles by which research is conducted nationally and internationally Can explain: The requirement for ethical review Unethical research practice Can explain and place in an historical context: The Nuremberg Code The Declaration of Helsinki Belmont Report Medical Research that has influenced the development of ethical principles and ethical review GAfREC Page 15 of 69

16 Complete understanding Demonstrate the conduct of a study in of the ethical principles and implications of clinical accordance with the conditions of approval research, including Can identify what constitutes a breach in documents policy and the ethical conduct of a study legislation ensuring Takes appropriate action when breaches protection of the rights of of ethics have occurred research participants Manages submissions for ethical review identifying ethical issues and recommend change to protect participant s rights. Collates full submission for ethical review Completes: - NRES Form - Participant Information Sheet - Consent Form - Trial related information - documentation including adverts and other information - Attends Ethics Committee - Completes reports Annual and Safety to the Ethics Committee Page 16 of 69

17 6. Investigator Meeting The Research Nurse can plan and attend an Investigator meeting Is aware of the remit and function of Investigator meetings Can list what should be discussed at an Investigator meeting Can indicate what training should take place Can identify common protocol flaws that may affect recruitment Knowledge of the study protocol attends Investigator meeting as part of the study team In depth knowledge of study specific protocols to influence protocol revisions from a nursing and participant perspective Comprehensive Knowledge of study Able to identify own training needs in relation to study protocol and the standardising of study techniques Able to identify protocol specific problems and prepare a plan to resolve these back at site Able to network and liaise with sponsor and other research nurses at multiple sites Able to attend investigator meetings and report back to investigator study specific issues Represents the investigator an/or other members of the research team at Investigator meetings Provides expert nursing/disease speciality input to drive revisions for incorporation into final study protocols Provides significant input and represents the investigator an/or other members of the Page 17 of 69

18 specific protocols and can research team at Investigator meetings represent the P I/CRF at Can organise and set an agenda for an an Investigator Meeting investigator meeting on behalf of a CI for multi centre investigator led research Manages a portfolio of studies ensuring staff allocated to attend investigator meetings are briefed and uses feedback to inform portfolio management Manages and oversees CRF staff attendance at Investigator meeting Arranges feedback sessions from attendees Develops a system to use information to influence portfolio, staff and resource management Page 18 of 69

19 7. Study Site Initiation The Research Nurse can plan and attend a Site Initiation visit STH NHS FOUNDATION TRUST Is aware of the remit and Can identify what should be discussed function of formal study and covered in a Site Initiation visit site initiation visits Can list the different personnel who should be present Attends Site Initiation visits. Understands the relevance. Comprehensive knowledge of the requirements at site for individual projects site initiation. Manages Site initiation process on behalf of Investigator led research. Prepares adequately for site initiation Able to work to Site Initiation checklists Identifies own actions following initiation visit Prepares standard CRF documentation for the sponsor for inclusion in their Master File Indicates if there is a need for further initiation information Prepares site initiation documentation for all sites Ensures all sites are instructed and competent in the following - The protocol - study delegation - Informed consent procedure - CRF completion - Key GCP issues - Source documentation - AE/SAE reporting Page 19 of 69

20 - Study drug management and accountability - Specialist procedures - Approvals - Frequency of monitoring Manages portfolio of studies ensuring all projects have a site initiation appropriate to the study design Devises checklist itemising all areas to be covered with all site staff Ensures initiation visits are adequate for the staff allocated to a project Organises specialist training identified Page 20 of 69

21 8. Study Set Up The Research Nurse can plan and complete Study Set Up STH NHS FOUNDATION TRUST Aware of the importance Can identify the components necessary of efficient and comprehensive Study Set for study set up With supervision: Up co-ordinates study meetings for the research team Understands the process of efficient and comprehensive study set up In depth knowledge of individual protocol to enable full study set up Comprehensive knowledge of study set up applying different approaches to individual protocols Manages a portfolio of studies ensuring appropriate set up is in place Organises study set up Gathers information to use in the preparation of study specific documents Creates working file Creates study specific documents Creates Study proformas Writes study specific SOPs Co-ordinates investigators, researchers in the set up of complex research projects Advises and supervises others planning study set up Educates others in study set up Manages the set up for a portfolio of studies Monitors others conducting study set up within the CRF Page 21 of 69

22 9. Participant Information The Research Nurse can plan and create Participant Information STH NHS FOUNDATION TRUST Aware of the importance Can identify the components of standardised of information provided to Participant Information Sheet. ICH/GCP research participants Can identify the components of a consent form for research Understands the procedures for providing participants information during clinical research. What format the information should be presented in and the approvals necessary for information for research In depth knowledge of an individual research protocol to create project specific participant information Comprehensive knowledge of creating Can describe the procedure for the provision of information to research participants Provides information for inclusion in research participant information sheet Identifies the approvals necessary for written and verbal participant information Identifies key times when participants should be provided with information during a study Creates project specific participant information sheet for submission to ethics Revises participant information sheets in line with protocol amendments Ensures participants are informed at all stages of the research process Creates patient training information e.g. drug administration instructions or technical training Advises others on the creation of participant information creation Page 22 of 69

23 participant information and Identifies need for and arranges for translation gaining all relevant Creates alternative medium for information approvals. Including the presentation e.g. pictorial, video etc identification of the most suitable medium for providing information Manages and monitors participant information across a portfolio of studies Advises on the creation of participant information across all CRF studies and advises on complex issues relating to participant information Create systems to ensure the current /approved PIS are in use for all studies Page 23 of 69

24 10. Informed Consent The Research Nurse can fully inform research participants throughout the study/trial Knowledge Skills Level Evidence of Achievement Aware of the importance Can describe the importance of a robust consent of gaining full informed procedure in research consent from research Can describe how this procedure is conducted participants Identifies who is responsible for the Informed consent process in research Initials and Understands the principles that underpin the informed consent procedure and the related SOPs In depth knowledge of a specific research protocol able to provide participants with full information about a study Describes the ethical principles that underpin the Informed Consent Process Can identify in what documentation the consent process will be described on an individual study basis Can identify the correct process for obtaining informed consent Can identify the correct documentation to be used and where it is filed Can identify the correct procedure for recording informed consent Follows SOPs Can provide accurate and up to date information and an explanation of a specific research protocol Does not coerce or allow coercion of a possible participant Ensures the participant s legal rights are maintained Allows the participant sufficient time to consider Page 24 of 69

25 Knowledge Skills Level Evidence of Achievement and/or seek additional advice Can answer any of the subjects trial related questions Ensures the participant has the opportunity to discuss the study with the PI or study doctor Ensure the participant and the doctor taking consent sign the form on the same date Initials and Comprehensive knowledge of specific research protocols, disease being studied and the IMP / Device / Intervention under investigation to provide participants with full information about a study. Knowledge to assess participants understanding of the information provided Manages and monitors the informed consent procedures across a portfolio of studies Specialist in the disease area and population being researched. Specialist knowledge of the protocol/imp/device/intervention or is PI for the study Excellent communication skills (must be evidenced by attendance at an accredited communication course) Ensures the PI delegates the task and the line manager/sponsor/ec approves the delegation and documents are in place to verify this Identifies situations when additional input is needed Develops systems to monitor the Informed Consent process across a portfolio of studies Monitors the informed consent process across a portfolio of studies Acts on GCP non-compliance in relation to Informed Consent Page 25 of 69

26 11. Confidentiality The research nurse maintains confidentiality both participant and researcher throughout the trial Knowledge Skills Level Evidence of Achievement Aware of the importance of confidentiality in research and in the NHS Can identify areas where confidentiality is relevant in research Describes the function of a confidentiality agreement Operates within the STH Trust Confidentiality Policy Initials and Understanding of the principles, policies and SOPs created to ensure participant and sponsor confidentiality In depth knowledge of Trust policies relating to patient confidentiality and sponsor confidentiality requirements in relation to individual research protocols Comprehensive knowledge of confidentiality requirements across the CRF Manages breaches of confidentiality in line with Trust policies Protects Sponsor confidentiality Protects participant confidentiality Follows CRF SOPs and Trust Policies Recognises breaches of confidentiality Reports breaches of confidentiality according to SOPs and STH policies Monitors staff and CRF for breaches of confidentiality Acts on breaches of confidentiality according to Trust policy Page 26 of 69

27 12. Data Protection The Research Nurse understands the Data Protection Act in relation to research and patient data Aware of importance of Read the Data Protection Act 1998 data protection in the NHS Describes the importance of the DPA to and in relation to research the CRF and research Can name the Data Protection Officer (DPO)for STH Understands the principles of the data protection act and Trust data protection policies and procedures In depth knowledge of data protection applicable to individual research projects and can complete applications for Data Protection Officer (DPO) approval Comprehensive knowledge of data protection procedures applicable to a portfolio of Identifies and understands the 8 principles of the DPA 1998 Works to the STH Data Protection Policy and STH Research Department Data Protection SOP Can identify the difference between Personal data and Sensitive Personal Data Completes STH applications to the DPO On a study basis complies with the DPA in relation to: - Anonymisation - Data Storage - Data Access - Data Transfer - Data Identification Identifies the special provisions for research Ensures all studies comply with the DPA Page 27 of 69

28 studies Ensures all CRF study data is anonymised, stores, accessed, transferred and identified according to the DPA and sponsor requirements Manages breaches of data protection in line with Trust and R&D policies and procedures Acts on breaches of the DPA according to Trust policies Information Governance Data Protection Freedom of Information Information security Ensures all CRF users comply with the DPA Page 28 of 69

29 13. Data Collection The Research Nurse can collect and verify data collected as part of the research process Aware of the importance Describes the Two main methods of of data collection and collecting research data accurate record keeping in Can record source data accurately relation to research Identifies what constitutes source data Understands the principles and procedures for accurate and timely data collection In depth knowledge of an individual method of data collection for specific research protocols Comprehensive knowledge of a variety of methods of data collection across a portfolio of studies Follows SOPs for data entry IT literate to enable accurate data entry Ensures data is entered in a timely manner in line with CRF SOPs Can describe a data audit trial Manages data entry for a specific study Liaises with the sponsor regarding data collection In depth knowledge of individual CRF completion Performs source data validation with CRAs Can manage simultaneously paper and electronic systems for data capture across numerous studies Monitors the collection of data by CRF team across studies Page 29 of 69

30 Manages the creation of Designs data collection systems and advises on specific Develops systems for monitoring the clinical data collection quality of data capture in the CRF. systems for research Validates data systems protocols Page 30 of 69

31 14. Identification of Study Participants The Research Nurse can create a strategy for participant identification for any research protocol Aware of the mechanisms Describes methods of participant available for the identification identification of study Can identify what methods are inappropriate participants Understands the processes and approvals for correctly identifying study participants In depth knowledge to ensure correct method of participant identification for individual studies Comprehensive knowledge applied to identify participants for a portfolio of studies Manages systems for the identification of study participants Can identify how participants can be sourced for individual studies Works with the PI to identify research participants Identifies research participants in compliance with the study approvals Attends Clinics/MDTs to identify possible study participants Works with other members of the clinical team to identify research participants Identifies participants across a portfolio of studies Ensuring systems adhered to by all team members for individual studies Creates and manages systems for the identification of study participants Manages Healthy Volunteer database Creates and monitors systems to prevent over participant involvement in studies Page 31 of 69

32 15. Recruitment The Research Nurse can create a recruitment strategy for any research protocol Aware of recruitment Describes the need for a recruitment strategies for clinical strategy for all research studies research Identifies how this should fit with study timelines Understands the various mechanisms for recruitment to meet targets and timelines within a protocol In depth knowledge applied to the recruitment to individual studies Comprehensive knowledge to enable recruitment to a portfolio of studies. Including suggesting alternative recruitment strategies for Works within approvals Identifies study timelines Can state recruitment target Can identify when recruitment closes Plans recruitment schedule for individual studies Revises recruitment strategy if behind target Reports regular updates of recruitment rates Assess and identify possible barriers to recruitment Ensure all recruits fit protocol inclusion exclusion criteria and record in source data Manages recruitment strategy across a portfolio of studies Ensures team members are recruiting to study timelines Advises others with recruitment solutions Page 32 of 69

33 studies Monitors recruitment across studies to inclusion exclusion criteria Manages the recruitment targets for all studies monitoring team performance Monitors CRF performance across all CRF studies to targets and timelines Ensures revisions in targets or deadlines are referred to CRF Finance Officer and identifies need for CTA revision if appropriate Reports prepared for CRF Executive and Management team Page 33 of 69

34 16. Investigator Site File The Research Nurse can create and maintain a Site File STH NHS FOUNDATION TRUST Aware of the need for the Identifies what constitutes essential Investigator Site File and documentation in a clinical trial essential documentation Can create a Site File for Investigator led research using the STH Site File Template Understands the need for essential documentation and GCP requirements In depth knowledge of the essential documents required to be kept in the Site File and the management of the file for an individual study Under supervision: Maintains Site Files to GCP standards Maintains essential documentation to the sponsors required format Files all study specific essential documents in the site file on receipt or within 48 hours Ensures all essential documents are present and in good order Ensures all approvals and subsequent actions occur in the correct sequence Ensures all Delegation logs are accurate and complete Ensures all study personnel training logs are up to date Ensure Screening and Recruitment Logs and Consent forms are filed All documents in use are version controlled and the correct version is in use at all times Ensures Study specific SOPs are in place Page 34 of 69

35 Comprehensive Maintains a series of site files across a portfolio knowledge and of studies maintenance of Supervises junior staff in the maintenance of Investigator Site Files and Site Files essential documentation Monitors own staffs maintenance of essential for a portfolio of studies documents Advises staff/investigators on maintaining Site Files Manages QA systems for ensuring all Site Files are maintained to allow recreation of the study at inspection Develops systems to monitor quality of essential documentation within the CRF Monitors for QA CRF Site Files Page 35 of 69

36 17. CRF Equipment The Research Nurse can manage the equipment in line with STH and CRF procedures Knowledge Skills Level Evidence of Achievement Aware of the Trust and Read and understood the STH Policy on the CRF policies for the management and decontamination of equipment procurement, Read and understand STH Infection control management and policy decontamination of equipment Understands and follows the Trust and CRF policies and procedures relating to equipment management. In depth knowledge of the management of CRF equipment. Manages study specific equipment procedures Comprehensive knowledge of the management of CRF equipment. Equipment management across a portfolio of studies Manages CRF equipment systems Describes the process and follows SOPs for equipment management Manages individual pieces of equipment under supervision Manages the receipt of study specific equipment Organises Decontamination paperwork Organises Biomedical engineering checks and approval Ascertain whether indemnity is required Organises additional disposables as required Manages equipment across a portfolio of studies Ensure team members manage their study equipment according to Trust policies and SOPs Responsible for the system ensuring all equipment is service maintenance and calibration Initials and Page 36 of 69

37 18. Administering Questionnaires/Validated assessment tools The Research Nurse can use questionnaires and assessment tools as part of a research protocol Aware of the use of Reviews questionnaires to become familiar questionnaires and with those most frequently used in the CRF validated assessments in Defines a validated assessment tool clinical research Understands how different questionnaires and assessment tools can be used in clinical research Describes the rationale for the use of different questionnaires incorporated in clinical trials Can list the most commonly used assessment tools that are used in clinical trials Describes how questionnaires are best administered to participants In depth knowledge of questionnaires and assessment tools for individual research studies Comprehensive knowledge of different questionnaires and assessment tools across a Administers questionnaires and assessment tools for individual studies under supervision Seeks guidance / training if necessary Ensures all questionnaires and assessment tools are administered in line with the protocol Ensures participant compliance if questionnaires are to be completed and returned Able to use a variety of different questionnaires and assessment tools across a portfolio of studies Supervises other team members completing Page 37 of 69

38 portfolio of studies questionnaires Manages training in the use of different questionnaires and assessment tools. Advises on suitability for use in specific projects. Trains and assesses competency in the use of different questionnaires and assessment tools Advises researchers on the incorporation of questionnaires into individual studies Assists in the design and validation of questionnaires and assessment tools Page 38 of 69

39 19. Preparation of Study Specific Information The Research Nurse can prepare study specific information STH NHS FOUNDATION TRUST Aware of the requirement Describes what type of information might be to provide study specific necessary to provide information Describes why it is important to prepare study specific information Understands the importance of well prepared study information for both research and clinicians involved in routine care In depth knowledge of the information to be provided on an individual study basis Comprehensive knowledge of information provided across a portfolio of studies Identifies recipients of study specific information Identifies specific timelines and routes of communication Follows CRF and STH Researchers SOPs Prepares information on an individual study to inform clinicians, clinic staff, ward staff, MDT Arranges meetings to regularly update clinicians, clinic staff, ward staff, MDT Prepares and circulates newsletters or regular written updates Prepares updates for CRF Management Team on individual studies Prepares and manages information dissemination across a portfolio of studies Ensures all updates are timely and feedback is provided to the PIs Prepares comprehensive updates for CRF Management Team on a portfolio of studies Page 39 of 69

40 Manages systems to Manages systems to ensure information provide and monitor study specific information within provided by the CRF staff, both written and verbal, is of a consistently high standard the CRF Monitors appropriateness of information Advises on strategy for planning information provision when studies are in the planning stages Manages CRF information systems Page 40 of 69

41 20. Safety Reporting The Research Nurse understands and completes safety data for studies Aware of the requirement Describes the systems in place to monitor safety in to monitor safety in clinical clinical trials trials Read and understood CRF and STH Research Department SOPs that relate to safety reporting Read and understood the STH Trust incident reporting system, familiar with Datix reporting Understands the requirements for safety reporting to the regulatory authority, sponsor and ethics committees In depth knowledge of the safety reporting requirements for individual research studies Can describe the recording reporting requirements of AEs to the regulatory authority, Ethics Committee, Sponsor, Trust R&D Can describe the recording and reporting requirements for SAEs to the RA, REC, Sponsor and Trust R&D Can describe the recording and reporting requirements for SUSARs to the RA, REC, Sponsor and Trust R&D Can outline the remit of a data monitoring committee Identifies AEs and SAEs and records and reports these according to the sponsor SOPs In depth knowledge of an individual research protocol and can itemise any events that are not to be defined as AEs as outlined in the study protocol Follows up both AEs and SAEs to resolution Ensures the participants safety at all times Page 41 of 69

42 Follow Sponsor and CRF SOPs Comprehensive knowledge of the safety reporting requirements for a portfolio of clinical research studies Manages systems and procedures within the CRF for safety reporting Identifies and reports AEs and SAEs across a portfolio of studies In depth knowledge of the reporting requirements of the sponsor and protocol Follows Sponsor SOPs Monitors participant safety Writes SOPs Develops systems to monitor safety reporting within the CRF Monitors staff and their reporting and management of AEs and SAEs Provides overall safety reports of CRF activity to CRF management and executive Advises researchers on the safety reporting requirements during protocol development Page 42 of 69

43 21. IMP Management and Accountability The Research Nurse manages and accounts for all IMPs STH NHS FOUNDATION TRUST Knowledge Skills Level Evidence of Achievement Initials and Aware of the Trust Read and can access the STH Medicines Code Medicines Code and the Read and can access CRF SOPs relating to the CRF procedures for the Management and Handling of IMPs management and Can define IMP accountability of Investigational Medicinal Products (IMPs) Understands fully the Trust Medicines Code and the CRF procedures for the management and accountability of IMPs Understand fully the STH Medicines code Understands CRF SOPs relating to the management for IMPs in the CRF Know how to access STH Research Department SOPs relating to IMPs In depth knowledge of the CRF procedure for the management and accountability of IMPs in place for individual clinical trials Can describe the safety profile of the IMP for an individual study Liaises with the Pharmacy Clinical Trial Coordinator for Pharmacy involvement in an individual study (costs, prescribing, storage, dispensing, return of unused study medication, destruction arrangements) Follows sponsor SOPs for the management of IMP Ensures participants are taking / administering the study drug in the correct manner and the correct dose as indicated in the study protocol Completes all CRF documentation logging receipt of drug into CRF and returns to Pharmacy Ensures whilst the drug is in the CRF it is stored Page 43 of 69

44 Knowledge Skills Level Evidence of Achievement Initials and securely and at the appropriate temperature and within timelines compatible with the study protocol Ensure all study drug administration is recorded in the CRF and source data Ensure all IMP dispensed to or returned by participants is recorded in the source data and CRF Knows the unblinding procedure for the study including emergency Sponsor and STH Pharmacy contacts Comprehensive knowledge of the CRF procedure for the management and accountability of IMPs for a portfolio of studies Can describe the safety profile of the IMPs for a portfolio of studies Liaises with the Pharmacy Clinical Trial Coordinator for Pharmacy involvement in a portfolio of studies (costs, prescribing, storage, dispensing, return of unused study medication, destruction arrangements) Follows sponsor SOPs for the management of IMP Ensures participants are taking /administering the study drugs in the correct manner and the correct dose as indicated in the study protocols Completes all CRF documentation logging receipt of drug into CRF and returns to Pharmacy Ensures whilst the study drug is in the CRF it is stored securely and at the appropriate temperature and within timelines compatible with the study protocols Ensure all study drug administration is recorded in the CRF and source data Page 44 of 69

45 Knowledge Skills Level Evidence of Achievement Initials and Ensure all IMP dispensed to or returned by participants is recorded in the source data and CRF Knows the unblinding procedure for the studies including emergency Sponsor and STH Pharmacy contacts Manages the systems in place in the CRF for the management and accountability of IMPs Develops systems for the safe management of study drug in the CRF Conducts monitoring and spot checks to ensure CRF SOPs are being followed Trains CRF staff in IMP management Creates SOPs for sign off by the CRF Management Team Page 45 of 69

46 22. Sample Management and Processing The Research Nurse processes and manages all sample handling STH NHS FOUNDATION TRUST Knowledge Skills Level Evidence of Achievement Aware of Good Laboratory Read GLP standards relevant to laboratory work Practice (GLP) standards conducted in the CRF and CRF Lab procedures Read CRF SOPs relating to laboratory practice Initials and Understands GLP and the CRF laboratory procedures In depth knowledge of lab procedures required for individual studies Comprehensive knowledge of a variety of lab procedures for a portfolio of studies Understands GLP in relation to the CRF Understands CRF SOPs relating to laboratory practice Completed CRF practical skills training in centrifuging, sample processing, handling, packaging, storing and dispatch of samples Understands the Trust Health and Safety Policy and Infection Control Policy in relation to practice in the CRF Can deal appropriately with spillages and equipment breakdown Operates lab processes as described in the lab manual for an individual study Completes all lab procedures to the highest standards in keeping with CRF SOPs Accesses and demonstrates proficiency in any protocol specific lab procedures Manages different lab procedures across a portfolio of studies Follows several lab manuals for a portfolio of Page 46 of 69

47 Knowledge Skills Level Evidence of Achievement studies Takes a CRF lead role for Health and Safety, Infection Control, Risk Management and training of lab procedures Writes CRF LAB Practice SOPs Initials and Manages systems to ensure sample management and processing are performed to a consistently high standard within the CRF Develops systems to ensure CRF lab procedures are consistent across studies Ensures visiting researchers and their teams operate safely within the CRF Lab Monitors training records and clinical competencies within the CRF Performs spot checks on sample activity within the CRF Page 47 of 69

48 23. Good Clinical Practice The Research Nurse understands and operates to GCP STH NHS FOUNDATION TRUST Aware of Good Clinical Has read the ICH/GCP guidelines Practice (GCP) legislation Has read the Medicines for Human Use GCP and guidance legislation Understands the principles and application of GCP in research In depth knowledge able to apply GCP to the conduct of individual clinical research projects Comprehensive knowledge applies GCP across a portfolio of research projects Can explain the requirement for GCP in research Demonstrates knowledge of GCP by describing the 13 core principles of GCP in relation to clinical trials Can outline the requirements of the Research Governance Framework Applies GCP to individual clinical research trials Recognises a breach of GCP in relation to the conduct of an individual clinical trial Applies GCP to the conduct of a portfolio of clinical trials Ensures the research team and investigator are compliant with the GCP legislation Acts on breaches of GCP Teaches GCP to researchers and research teams as part of the CRF education Refers complex GCP queries C:\Documents and Settings\Robertus\My Documents\Mariann\CRF\CRF Portfolio and Competency Template_DRAFT Final2.doc Page 48 of 69

49 Manages complex queries Manages complex GCP queries and refers and applications relating to on to Research Department if necessary GCP and research Manages systems to check compliance with conduct GCP standards within the CRF Develops and manages the system to ensure all CRF core staff and all users of the CRF are appropriately GCP trained Manages CRF Education and Development Programme ensuring all session content is compliant Page 49 of 69

50 24. Monitoring The Research Nurse understands QA systems and works independently with sponsor monitoring systems Aware of the requirements Can define monitoring in relation to clinical for the monitoring of the research conduct of research Can describe the relation of clinical trial monitoring to GCP standards Read and understood the STH Research Department monitoring documents and SOPs Understands the principles of monitoring and QA systems In depth knowledge of the monitoring requirements of an individual study Can define the role of the CRA Can describe the CRF monitoring system Can describe the difference between QA and QC systems Can describe the difference between Monitoring, Audit and Inspection Can describe the monitoring arrangements for an individual study Can identify the monitor by name including contact details and the frequency of monitoring visits Keeps a record of monitor visits to ensure compliant with those outlined in the protocol and trial agreement Ensures the PI is aware and is available for monitoring visits if required Ensures a robust mechanism for communicating with the trial monitor Page 50 of 69

51 Comprehensive Knowledgeable regarding the monitoring knowledge of the requirements for a portfolio of studies monitoring requirements Has robust communication systems for all for a portfolio of studies studies Arrangements to ensue monitors have adequate space and time to complete monitoring visits Ensures all CRF and source data are available for monitoring visits Ensure team members are fully prepared for monitoring visits Ensure team members complete all monitoring visit requirements Manages QA system for the monitoring of Research Teams and research conduct Monitors CRF staff for completion of monitoring requirements Monitors length and frequency of monitoring visits within the CRF Administers the internal CRF monitoring system for ensuring QA of CRF staff Develops a system for the monitoring and management of the CRF Outreach Research Nurse team Page 51 of 69