Competency Framework for Non-Clinical Research Staff

Birmingham and the Black Country Comprehensive Local Research Network

Greater Midlands Cancer Research Network

Pan Birmingham Cancer Research Network

Competency Framework for

Non-Clinical Research Staff

VERSION 1.0

[October 2011]

Acknowledgements

This framework has been adapted from clinical research competency frameworks including original

work by the North West Stroke Research Network, Pan Birmingham Cancer Research Network,

Essex & Hertfordshire Comprehensive Local Research Network, Pan London & Southern Cancer

Research Networks and Leslie Gelling and colleagues on behalf of the Clinical Research Nurse

Competency Framework Working Group.

Its development has been achieved through a series of focus groups, widespread iterative

stakeholder circulation and working group input. The commitment and contribution from members

of the Birmingham and the Black Country Non-Clinical Research Staff Forum

,

Greater Midlands

Cancer Research Network Data Manager Forum, members of the Working Group

and all those

who commented on the draft versions of this framework is acknowledged with appreciation.

It is the intention that this framework will be reviewed in April 2012 following a 6 month pilot and

annually thereafter. Your feedback and comments would therefore be gratefully received.

Hannah Reay

Lead Research Nurse, BBC CLRN

[email protected]

October, 2011.

Birmingham & the Black Country non-clinical research staff forum:

Khadijah Afsar Lisa Allen Kirsty Baron Amy Bennett Joanne Buckley-Griffith Richard Cawthraw William Clay Jane Crouch Rebecca Faville Hannah Fould Okdeep Kaur Maxine Lovell Mary O’Sullivan Sophie Perks Jane Rogers Davina Scott Lauren Scott Kavitha Shetty Alexander Skinner Audrey Smith Lisa Smith Tammy Smith Sundip Sohanpal Marion Tatman Angie Williams

Greater Midlands Cancer Research Network (GMCRN) data manager forum:

Susan Hendy Linda Higgins Ron Jones Marian McCormack Simon Shaw Dawn Sirdefield Hazel Spencer

Competency Working Group: Kevin Dunn – R & D Manager ROHFT Gina Dutton – Network Manager PBCRN Jayne Groves – Lead Nurse manager BBC CLRN Frances Lloyd – Lead Research Nurse SWBH Hannah Reay – Lead Research Nurse, BBC CLRN Jackie Sears – Lead Nurse PBCRN

Hazel Spencer – Senior Data Manager GMCRN Phillip Watson-Jones – Research Coordinator, UHBFT Linda Webber – Research Manager HEFT

Contents

Introduction

What is competence?

How to use this framework

Assessment

Summary of competencies

Essential levels of performance

Theme 1: Background to Clinical Research

1A. Guidance and Legislation

1B. Research in the NHS

1C. Study design

Assessment Summary

Theme 2: Study Set-up

2A. Study feasibility & site set-up

2B. NHS permissions process

Assessment Summary

Theme 3: Study Conduct

3A. Key personnel

3B. Administrative support & study supplies

3C. Consent

3D. Protocol specific requirements

3E. Managing priorities

Assessment Summary

Theme 4: Data Management

4A. Confidentiality & data protection

4B. Essential documents

4C. Data & CRF completion

4D. Data quality

4E. Safety reporting

4F. Storage & Archiving

Assessment Summary

Appendix I – Templates & Continuation Sheets

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Introduction

This is a competency framework for non-clinical research staff - anyone who contributes to

site-based clinical research teams but who is not clinically qualified and / or does not routinely

undertake clinical activities in their research role.

Although a number of different formats of clinical research competencies have been developed as

yet there is no national consensus of the knowledge, skills and attributes required of the

non-clinical staff that support site-based research teams. There appears to be a general lack of clarity

about the roles and responsibilities of these members of the team who have titles including ‘data

manager’, ‘data coordinator’, ‘data officer’, ‘research administrator’ and ‘research assistant’.

Discrepancies can be identified in the job descriptions of support staff who are seemingly

undertaking similar roles but who are subject to varying NHS bandings between organisations

(ranging from band 3 – 5 in BBC CLRN region) and who lack a career structure.

The purpose of this competency framework is to define the knowledge, skills and attributes of

non-clinical research staff in order to enable research staff to:

• Understand more clearly what is required from them

• Document their knowledge, skills, attributes and experience

• Identify learning needs and interests

• Provide evidence of achievement to support annual appraisals and to promote fair &

consistent assessment

• Demonstrate adherence to Good Clinical Practice (GCP)

• Recognise the contribution of every member of research team

• Identify opportunities for personal development, training & career progression

What is competence?

For the purposes of this document competence is defined as:

‘The ability to demonstrate the application of knowledge, skills, attitudes and

behaviours to achieve effective performance in a non-clinical research role’

A competency is the task or activity which is performed to enable inferences about competence to

be made. As an individual acquires knowledge, skills and confidence in their role they are able to

demonstrate increasing independence and higher levels of performance.

How to use this framework

The framework consists of four themes within which 16 specific research competencies are

defined. The themes are:

1.

Background to clinical research

2.

Study set-up

3.

Study conduct

4.

Data management

An essential level of performance has been defined for each competency, according to NHS band,

which staff are expected to achieve within their first three - six months in post (according to

previous experience and banding). The essential levels of performance (at each NHS ‘Agenda for

Change’ band 3 – 6) define the minimum level of achievement required. They should in no way

restrict or deter someone from aiming and achieving a higher level but indicate a common baseline

for all non-clinical research roles. The levels of performance are:

Level 1 – Aware of competency; understanding of basic principles

Level 2 - Is competent with assistance and supervision

Level 3 - Is competent with supervision

Level 4 - Is competent without assistance / supervision

Level 5 - Is competent and is able to assist / supervise others

Each competency is presented with examples of the knowledge, skills and behaviours that will be

required for competent performance, and examples of how competence may be demonstrated

based on a detailed review of non-clinical roles and responsibilities. However, these are by no

means exhaustive and should be used as a guide rather than a mandate.

The framework is intended to be sufficiently flexible to be of relevance to staff in a number of

different non-clinical research posts. As such it may be necessary to adapt it to meet local needs –

in particular it may be necessary to amend the knowledge / skills / behaviours or add discrete

clinical competencies (such as phlebotomy, laboratory skills or informed consent). Black

Competency Forms and Assessment Summaries have been included in the appendix to

accommodate this.

It should be noted that this framework focuses on core competencies unique to the research role

rather than generic knowledge, skills and attributes mandated within wider NHS strategies such as

the Knowledge and Skills Framework. There is inevitably some overlap; however whilst effective

communication (for example) is fundamental, it is not included as a competence in this framework

as it is not unique to this research role.

Network induction handbooks provide background reading and links to further resources, and the

Birmingham Research Training Collaborative (BRTC) offers training opportunities to support the

acquisition of each competency.

Assessment

An assessment framework similar to that proposed in the Competency Framework for Clinical

Research Nurses (version 2, October 2011), has been provided to enable the post holder and their

mentor / line manager to review and record their current level of performance within each

competency and set targets for progression (within and between job roles).

Space is provided to record evidence of achievement which may include (but is not limited to):

•

Evidence of everyday performance

•

Questioning / discussion whilst performing activities / during formal reviews

•

Formal Assessment

•

Evidence of attendance & reflection on training

•

Supporting evidence from colleagues, managers, peers or clients

Evidence must be:

•

Valid – the evidence must relate directly and appropriately to the competency

•

Sufficient – the evidence should not be a one off event but must demonstrate consistent

achievement

•

Authentic – the evidence must be the post holder’s own work or demonstrate their

significant role in collaborative work

•

Current – the evidence must demonstrate currency and should not be solely reliant on work

undertaken in the past (but past experience may be cited where relevant)

The post holder should collate evidence on an ongoing basis and notify their mentor / line manager

when they feel that they have sufficient evidence to demonstrate competence at the pre-agreed

level (& within agreed time frames). The mentor / line manager should regularly review the

evidence and work with the post holder to set objectives for ongoing development as part of their

local personnel review processes. A signature page is provided to enable ‘sign off’ but this should

not deter ongoing review to ensure competence is maintained over time.

Space is provided for each competency to record progression through all levels. However, it is not

necessary to demonstrate achievement of all competencies at one level before progressing to the

next, nor provide evidence of performance at each level below that of current performance.

Although examples within each competency have been provided as a guide, in general the

following broad indicators of performance may be applied:

Level 1

Aware of competency;

understanding of basic principles

“Know of”

Can discuss briefly with prompting for detail

Level 2

Is competent with assistance and

supervision

“Know how”

Requires assistance to identify and /or perform tasks and

activities. Has limited understanding of the rationale or

context for tasks / activities

Level 3

Is competent with supervision

“Show How”

Performs tasks and activities. Knowledge and understanding

restricted to own role / remit. Direct supervision from

mentor/line manager

Level 4

Is competent without assistance /

supervision

“Does”

Comprehensive knowledge & understanding. Autonomously

undertakes tasks and activities including problem solving.

Indirect supervision from line manager

Level 5

Is competent and is able to assist

/ supervise others

“Does more”

Expert knowledge with analytical skills. Leadership and

management roles. Indirect supervision from line manager

Summary of Competencies

Theme

Competence statement

The post-holder is able to...

1 : B A C K G R O U N D A: Guidance and

Legislation

Works within the regulatory frameworks governing clinical research

B: Research in the

NHS

Demonstrate an awareness of the background, political influence and

strategy regarding clinical research in the NHS

C: Study design

Demonstrate an understanding of the design and development of

different types of clinical research studies, especially clinical trials

2 : S T U D Y S E T -U

P A: Study feasibility & _{site set up}

Demonstrate an understanding of how studies and sites are assessed

_{for feasibility and contribute to site set up}

B: NHS Permissions

Process

Identify and discuss the permissions required to conduct research in

the NHS

3 : S T U D Y C O N D U C T

A: Key personnel

Demonstrate an awareness of the roles and responsibilities of key

personnel involved in clinical research

B: Administrative support & study supplies

Recognise the importance of efficient research administration &

undertake administrative tasks including the management of study

supplies

C: Consent

Demonstrate an understanding of valid informed consent in clinical

research and acknowledge their contribution to this ongoing process

D: Protocol-specific requirements

Demonstrate an understanding of study-specific protocol requirements

and implement strategies to facilitate adherence to the schedule of

events

E: Managing priorities

Prioritise tasks within studies and is able to identify and manage

priorities between studies

4 : D A T A M A N A G E M E N T A: Confidentiality &

data protection

Apply the principles of data protection & secure handling of data

B: Essential

documents

Identify and appropriately utilise essential documents in the conduct of

research studies

C: Data & CRF completion

Demonstrate accurate data capture and Case Report Form completion

including timely submission of data

D: Data quality

Manage data queries and demonstrate an understanding of the role of

monitoring, audit and inspection in the maintenance of data quality

E: Safety reporting

Demonstrate an understanding of the principles and process of

Adverse Event reporting (AEs, SAEs and SUSARs)

F: Storage & archiving

Apply the principles of secure storage and retention of data / study

documentation

Essential Levels of Performance

Level 1 – Aware of competency; understanding of basic principles

Level 2 - Is competent with assistance and supervision

Level 3 - Is competent with supervision

Level 4 - Is competent without assistance/supervision

Level 5 - Is competent and is able to assist / supervise others

Within six months of appointment the post-holder should be performing at or above the minimum level

Competence statement The post-holder is able to...

Level of Performance N H S _Band 3 Band 4 Band 5 Band 6 1 : B A C K G R O U N

D A. Demonstrate an understanding of the background and scope of the

regulatory frameworks governing clinical research 2 3 4 5 B. Demonstrate an awareness of the background, political influence and

strategy regarding clinical research in the NHS 1 2 3 5

C. Demonstrate an understanding of the design and development of different

types of clinical research studies, especially clinical trials 2 2 4 5

2 : S T U D Y S E T -U P

A. Demonstrate an understanding of how studies and sites are assessed for

feasibility and contribute to site set up 1 2 4 5

B. Identify and discuss the permissions required to conduct research in the

NHS 2 3 4 5 3 : S T U D Y C O N D U C T

A. Demonstrate an awareness of the roles and responsibilities of key

personnel involved in clinical research 3 3 4 5

B. Recognise the importance of efficient research administration & undertake

administrative tasks including the management of study supplies 3 3 4 5 C. Demonstrate an understanding of valid informed consent in clinical

research and acknowledge their contribution to this ongoing process 2 3 5 5 D. Demonstrate an understanding of study-specific protocol requirements and

implement strategies to facilitate adherence to the schedule of events 2 3 4 5 E. Prioritise tasks within studies and is able to identify and manage priorities

between studies 3 3 4 5 4 : D A T A M A N A G E M E N T

A. Apply the principles of data protection & secure handling of data 4 4 5 5 B. Identify and appropriately utilise essential documents in the conduct of

research studies 3 3 5 5

C. Demonstrate accurate data capture and Case Report Form completion

including timely submission of data 3 4 5 5

D. Manage data queries and demonstrate an understanding of the role of

monitoring, audit and inspection in the maintenance of data quality 2 3 5 5 E. Demonstrate an understanding of the principles and process of Adverse

Event reporting (AEs, SAEs and SUSARs) 3 4 5 5

F. Apply the principles of secure storage and retention of data / study

Theme 1 – Background to Clinical Research

Competence 1A: Guidance & Legislation

1A: Work within the regulatory frameworks governing clinical research

Knowledge

Skills & Behaviours

• Development of research ethics and governance related to clinical research • Principles of:

- Declaration of Helsinki - Nuremburg Code

- NHS Research Governance Framework 2005

- International Conference of Harmonisation Good Clinical Practice (ICH GCP)

• Relevant UK legislation:

- Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) & Amendment Regulations 2006 (2006/1928)

- Human Tissue Act - Mental Capacity Act

• Role of MHRA in the regulation of CTIMP and medical devices research • Serious breaches in GCP; procedures when breaches of protocol are identified

or when fraud / misconduct suspected

• Attends & maintains GCP training as per Trust/network policy • Applies the principles of GCP to everyday tasks and practices

• Demonstrates an interest in the background of clinical research and identifies the relevance of the regulatory frameworks that govern its conduct

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Attend Introduction to GCP course (certificate of attendance)

• Identify how the principles of GCP are implemented using an everyday example

• Discuss how the principles of GCP are implemented using everyday examples of your working practices • Recognises own limitations and

attends / completes relevant training

• Comprehensive understanding of the regulatory and legal frameworks related to the planning, delivery and closure of clinical research studies • Recognises own limitations and

attends / completes relevant training; supportive in the training of others

• Demonstrates leadership by: - Providing comprehensive advice &

guidance

- Ensuring processes, policies and standard operating procedures are in place to support compliance with regulatory requirements

Theme 1 – Background to Clinical Research

Competence 1A: Guidance & Legislation

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 1 – Background to Clinical Research

Competence 1B: Research in the NHS

1B: Demonstrate an awareness of the background, political influence and strategy regarding clinical research in the UK

Knowledge

Skills & Behaviours

• Political and strategic developments in clinical research: - NIHR & Department of Health (NHS) Strategy - Role of NIHR Research Networks

- Birmingham & the Black Country CLRN

- Local topic specific research networks relevant to post (e.g. Pan Birmingham Cancer Research Network)

• Research in the local NHS trust(s): portfolio and non portfolio research • Research in topic specific area of interest: academic / industry sponsored

studies

• Aware of studies in your own team / department / network

• Aware of research network in which you work and their role in supporting research in your Trust / Organisation

• Understands the relevance of historical development of clinical research to current research and policy

Examples of how competence may be demonstrated:

Level 1

Level 3

Level 4

Level 5

• Aware research is important to improve patient care

• Aware that research is embedded in the NHS

•

Demonstrate awareness of studies in own team / department and wider specialty area / network

•

Discuss your contribution to delivering research in the NHS

•

Aware of research network in which you work and their role in supporting research in your Trust / Organisation

•

Demonstrate knowledge of understanding of the historical and political context in which clinical research is being undertaken

• Demonstrates leadership by: - Providing comprehensive

information to support understanding of the political content and strategic developments which influence research in the NHS

- Championing the role of clinical research in the development of health and social care

-

Supporting and influencing the embedding of clinical research in local NHS infrastructure / practice

Level 2

• Attend Introduction to GCP course (certificate of attendance)

• Identify how the principles of GCP are implemented using an everyday example

Theme 1 – Background to Clinical Research

Competence 1B: Research in the NHS

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 1 – Background to Clinical Research

Competence 1C: Study Design

1C: Demonstrate an understanding of the design and development of different types of clinical research studies, especially

clinical trials

Knowledge

Skills & Behaviours

• Clinical research process

• Common acronyms used in clinical research

• Phases of clinical research – Preclinical, Phase I, II, III, IV

• Research study design including: protocol design & development, sample size & power, inclusion & exclusion criteria, randomisation, blinding and unblinding • CTIMP studies; pharmaceutical industry sponsored clinical trials – drug

discovery process & licensing of medicines in the UK and beyond • Multi-centre studies

• Qualititative & quantitative research

• Role and relevance of patient and public involvement in all stages of research process

• Identifies the research design and methodology used for trials / studies within the research team

• Seeks opportunities to understand the relevance of the design / methodology to their role and the wider research team

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Explain what a trial / study you are working on is about

• Identify the type and phase of a study which you work (e.g. CTIMP / non CTIMP / Phase I or II or III etc) how you know this & why it is relevant to know

• Discuss the design of a study on which you work (e.g. ‘double-blind’; ‘randomised’; ‘placebo controlled’ – what do these terms mean?)

• Discuss different research designs and methodologies and their relevance to / implications for members of the research team

• Has a comprehensive understanding of the research designs and

methodologies used in clinical research

• Demonstrates leadership by: - Providing comprehensive advice

& guidance for staff, researchers, patient & participants

- Contributing to protocol design and review

Theme 1 – Background to Clinical Research

Competence 1C: Study Design

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 1 – Background to Clinical Research

Assessment Summary

Satisfactory evidence has been collected and presented to demonstrate achievement of the following performance criteria:

Competence statement Date Achieved Post Holder

Signature

Date Achieved Assessor (PRINT & Initial)

T H E M E 1 : B A C K G R O U N D T O C L IN IC A L R E S E A R C

H

1A. Work within the regulatory frameworks

governing clinical research

Level 1 Level 2 Level 3 Level 4 Level 5

1B. Demonstrate an awareness of the background,

political influence and strategy regarding clinical

research in the NHS

Level 1 Level 2 Level 3 Level 4 Level 5

1C. Demonstrate an understanding of the design

and development of different types of clinical

research studies, especially clinical trials

Level 1 Level 2 Level 3 Level 4 Level 5

Theme 2 – Study Set-up

Competency 2A: Study Feasibility & Set-up

2A: Demonstrate an understanding of how studies and sites are assessed for feasibility and contribute to site set up

Knowledge

Skills & Behaviours

• Identification of sites to conduct research – requirements (staff / facilities / subjects)

• Costing & funding research

• Site preparation including site initiation visits • Processes for participant recruitment • Pathway planning

• Risk assessment & feasibility

• Recognise the importance of planning prior to a study opening

• Identify opportunities to contribute to feasibility assessments – identification of patients for pre-screening / database searches; attend MDT / clinical meetings • Liaise with R & D dept / support services to arrange set-up meetings (e.g.

initiation visits)

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Obtain documents for study set-up • Assist in the organisation and attend

site initiation visits

• Assist in the set-up of site files compliant with research governance and GCP requirements

• Assist with the acquisition /

distribution / tracking of relevant trial documentation for study set-up • Establish trial site files compliant with

research governance and GCP requirements

• Participate in feasibility assessments

• Utilise patient pathway planning to assess study feasibility and identify study specific processes for recruitment / plan study schedule • Identify relevant training for members

of the research team in relation to the • Requirements of a new study

protocol

• Undertakes risk and feasibility assessments

• Demonstrates leadership by: - Acting as a knowledable resource

for staff and researchers involved in assessing feasibility & setting-up new studies

- Contributing to the supervision and educational needs of staff involved in site set-up

- Liaising with sponsor

representatives & responding to feedback regarding feasibility and / or set-up

Theme 2 – Study Set-up

Competency 2A: Study Feasibility & Set-up

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 2 – Study Set-up

Competency 2B: NHS Permissions

2B: Identify and discuss the permissions required to conduct research in the NHS

Knowledge

Skills & Behaviours

• Role and responsibilities of National Research Ethics Service (NRES); structure of Research Ethics Committees (RECs) & committee membership

• Role and responsibilities of R & D departments

• Processes for the submission of regulatory applications and their review (e.g. REC / R & D / MHRA)

• Key documentation required to support REC and R & D submissions • Local policies and procedures related to ethical review and research

governance

• Regulatory requirements for protocol amendments (substantial and non substantial), termination and/or closure of a trial

• Indemnity, financial and contractual agreements

• Regulatory reporting procedures when breaches of protocol are identified or when fraud / misconduct is suspected

• Recognises the need to ensure that appropriate ethical opinion and governance approvals are obtained before any research activities are undertaken

• Contributes to the preparation and submission of applications • Utilise systems to gain NHS permission (e.g. IRAS / CSP)

• Assist with the acquisition / distribution / tracking of relevant trial documentation for study set-up

• Recognises the importance of clear, complete and accurate submissions

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Identify the regulatory permissions that have been obtained for studies on which you currently work

• Explain local and national processes for gaining approval to conduct clinical research

• Identify the specific regulatory permissions required for a new study and discuss the processes by which these are obtained

• Identify relevant trial documentation required to support regulatory applications

• Familiar with regulatory requirements of CTIMP and non CTIMP studies and the processes by which these are obtained

• Contribute to the preparation & submission of ethics / local R & D applications

• Discuss the role and remit of

research ethics committees in the UK

• Prepares or makes significant contribution to the preparation & submission of ethics / local R & D applications

• Demonstrates leadership by: - Acting as a knowledgeable

resource for staff and researchers making applications for regulatory approvals

- Contributing to the supervision and educational needs of staff involved in the preparation of regulatory applications

Theme 2 – Study Set-up

Competency 2B: NHS Permissions

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 2 – Study Set-up

Competency 2B: NHS Permissions

Satisfactory evidence has been collected and presented to demonstrate achievement of the following performance criteria:

Competence statement Date Achieved Post Holder

Signature

Date Achieved Assessor (PRINT & Initial)

T H E M E 2 : S T U D Y S E T -U P

2A. Demonstrate an understanding of how studies

and sites are assessed for feasibility and

contribute to the initial stages of site set-up

Level 1 Level 2 Level 3 Level 4 Level 5

2B. Identify and discuss the permissions required

to conduct research in the NHS

Level 1 Level 2 Level 3 Level 4 Level 5

Theme 3 – Study Conduct

Competency 3A: Key Personnel

3A: Demonstrate an awareness of the roles and responsibilities of key personnel involved in clinical research

Knowledge

Skills & Behaviours

• Role & responsibilities of Sponsor and Chief Investigator (CI)

• Site staff and their responsibilities including Principle Investigator (PI), Research Nurse, Data Manager, Research Assistant, Other clinical staff, Research subjects

• Delegation of duties and documentation of this process

• The role and remit of sponsor delegates: Contract Research Organisations (CRO); Clinical Trials Units (CTU)

• Trial Management, Trial Steering Groups, Data Monitoring & Safety Committees

• Contributes to the deliver of clinical research protocols as a member of the research team

• Identifies & consistently works within scope of own role and delegates duties • Aware of limitations of own role and seeks help & support appropriately • Maintain up-to-date delegation or duties log, records and training and/or CVs • Establishes and maintains effective working relationships with relevant

individuals and organisations

• Contributes to research team meetings

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Completes delegation log for a new trial and demonstrates understand of delegated duties

• Consistently seeks help and support from members of the research team • Can identify key personnel within the

clinical research team

• Attend relevant training in relation to the requirements of the study protocol

• Able to differentiate between the roles and delegates duties of key personnel within the clinical research team

• Articulates own responsibilities and recognised the boundaries of their own role

• Consistent works within scope of own role and delegated duties; seeks help from appropriate members of the team

• Identify relevant training in relation to the requirements of the study

protocol

• Consistently work within scope of own role and delegated duties; consult appropriately

• Promotes team working

• Comprehensive understanding of the roles and responsibilities of key personnel within the clinical research environment

• Ensures comprehensive induction is provided for all new staff

• Demonstrates leadership by: - Contributing to the development

and training of colleagues - Efficient & effective networking

Theme 3 – Study Conduct

Competency 3A: Key Personnel

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 3 – Study Conduct

Competency 3B: Administration & Supplies

3B: Recognise the importance of efficient research administration & undertake administrative tasks including the management

of study supplies

Knowledge

Skills & Behaviours

• Ordering & maintaining study supplies (e.g. CRFs, questionnaires, sample kits) • Administrative skills: managing telephone enquiries / photocopying / facing /

filing

• Acquisition and return of clinical records (e.g. Medical records) • In-house documentation systems

• Sponsor documentation systems

• Maintain sufficient stocks of documentation and equipment

• Manage telephone enquiries including timely and appropriate referral and documentation

• Proficiency with Microsoft Office applications: Word, Outlook (email and diary), Excel

• Efficient communication through a variety of media (telephone / email / face to face etc)

• Manage day to day queries – liaise with team members as appropriate and document

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Consistently seeks appropriate support / referral to manage telephone enquiries

• Completes administrative tasks efficiently

• Organises research documentation in clinical records

• Completes accurate documentation associated with research study supplies

• Establish and/or maintain in-house documentation systems

• Orders supplies and ensures they are available when required • Ensures clear and accurate

documentation is maintained on the arrival, use and disposal of research study supplies

• Establish and/or maintain accurate contacts

• Contributes to the effective and efficient use of resources

• Proactively manages study supplies and ensures that necessary staff and facilities are available (e.g. clinic room) for the effective conduct of the study

• Consistently manage day to day queries and liaise appropriately to ensure their effective resolution • Involved in the management of staff

as a resource

• Demonstrates leadership by: - Managing a research team with

attention to skill mix

- Aware of financial constraints of the funding available for a clinical research study

Theme 3 – Study Conduct

Competency 3B: Administration & Supplies

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 3 – Study Conduct

Competency 3C: Consent

3C: Demonstrate an understanding of valid informed consent in clinical research and acknowledge their contribution to this

ongoing process

Knowledge

Skills & Behaviours

• Principles of informed consent for participation in research – legal and governance requirements

• Information and key components of patient information sheets (PIS) & consent forms

• Preparation of PIS & consent forms for local use (version control; headed paper etc)

• Study specific documentation – signatures required; copies – how many & to whom; documenting the process of content

• Storage of signed consent form

• Team roles & responsibilities in gaining and maintaining informed consent

• Recognises the need to ensure that informed consent has been obtained and maintained; proactively seeks information to support this before undertaking study-related activities

• Prepare / track patient information sheets (PIS) & consent forms with attention to version control

• Assures patient safety by recognising & raising any concerns with the consent process

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Acknowledge the need for consent in clinical research

• Identify evidence of the consent process in source data and CRFs

• Give a brief overview of the consent process for a specified study – who can be involved and how is it documented?

• Can describe their role in the process • Proactively seeks documentation to

confirm consent has been provided by the participant

• Identifies errors / cause for concern in consent documents

• Identifies errors / cause for concern in documents

• Clearly articulates their role and the roles of other team members in the informed consent process; fulfils but does not exceed their delegated duties

• Reports any concerns with consent processes in a timely and

appropriate manner; can cite examples from practice.

• Demonstrates leadership by: - Acting as a knowledgeable

resource and role model for staff and researchers regarding the contribution of non clinical staff to the consent process

Theme 3 – Study Conduct

Competency 3C: Consent

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 3 – Study Conduct

Competency 3D: Protocol Specific

3D: Demonstrate an understanding of study-specific protocol requirements and implement strategies to facilitate adherence to

the schedule of events

Knowledge

Skills & Behaviours

• Protocol – main sections; extracting information

• Protocol – study specific requirements inc. eligibility criteria and schedule of events

• Randomisation process • Patient pathway planning

• Screening & eligibility: including and exclusive criteria; screening logs • Safe handling of samples including storage (at various temperatures) and

management of spills

• Ordering Couriers; Packaging and shipment of samples (handling of dry ice if applicable)

• Processes for participant recruitment

• Understands the rationale behind adherence to ethically approved study protocols

• Verify inclusion / exclusion criteria of subjects recruited into trials and ensure all relevant baseline data base been recorded

• Randomises / registers patient to trials according to the protocol requirements • Assist in ensuring protocol required tests / procedures are done according to the

protocol schedule

• Liaise with support services to book tests / procedures • Plan study visit / follow-up schedules

• Identify protocol schedule of events

• Develop checklists / workbooks / flow-sheets • Arrange couriering of samples

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Explain what a trial / study you are working on is about

• Demonstrate an awareness of the eligibility criteria of a chose protocol(s)

• List content sections of chosen protocol(s)

• Demonstrates effective use of protocols by referring to appropriate sections as required

• Aware of how to raise concerns and report instances of suspected protocol deviation; can cite examples from practice of protocol deviations

• Consistently adheres to the study protocol

• Plans patient pathway for trial identifying service and resource challenges

• Contributes to the development of policies and SOPs to support adherence to protocols

• Demonstrates leadership by: - Providing comprehensive guidance

& contributing to the training and development of colleagues

- Effective networking across clinical departments

Theme 3 – Study Conduct

Competency 3D: Protocol Specific

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 3 – Study Conduct

Competency 3E: Managing Priorities

3E: Prioritise tasks within studies and is able to identify and manage priorities between studies

Knowledge

Skills & Behaviours

• Prioritising work • Planning workload • Time management

• Reviewing and reassessing priorities and workload • Implications of tasks on study timelines & workload

• Identify workload priorities • Plan workload

• Identifies & alerts team members to expected delays or competing priorities • Identifies skills required to compare a task successfully

• Appropriate delegate & follow-up

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Undertakes identified tasks / activities within pre-define time frames (requires assistance to define priorities & time frame)

• Plans work and identifies priorities • Seeks support and assistance

appropriately to meet deadlines • Anticipates workload (e.g. monthly /

recurring tasks)

• Able to respond flexibly to changes in workload / priorities

• Recognises changing demands and is able to respond efficiently • Delegates appropriately

• Demonstrates leadership by: - Providing comprehensive advice &

guidance

- Delegating tasks appropriately and providing constructive feedback

Theme 3 – Study Conduct

Competency 3E: Managing Priorities

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 3 – Study Conduct

Assessment Summary

Satisfactory evidence has been collected and presented to demonstrate achievement of the following performance criteria:

Competence statement Date Achieved Post Holder

Signature

Date Achieved Assessor (PRINT & Initial)

T H E M E 3 : S T U D Y C O N D U C T

3A. Demonstrate an awareness of the roles and

responsibilities of key personnel involves in

clinical research

Level 1 Level 2 Level 3 Level 4 Level 5

3B. Recognise the importance of efficient research

administration & undertake administration tasks

including the management of study supplies

Level 1 Level 2 Level 3 Level 4 Level 5

3C. Demonstrate an understanding of valid

informed consent in clinical research and

acknowledge their contribution to this ongoing

process

Level 1 Level 2 Level 3 Level 4 Level 5

Theme 3 – Study Conduct

Assessment Summary

Satisfactory evidence has been collected and presented to demonstrate achievement of the following performance criteria:

Competence statement Date Achieved Post Holder

Signature

Date Achieved Assessor (PRINT & Initial)

T H E M E 3 : S T U D Y C O N D U C T

3D. Demonstrate an understanding of

study-specific protocol requirements and implement

strategies to facilitate adherence to the schedule

of events

Level 1 Level 2 Level 3 Level 4 Level 5

3E. Prioritise tasks within study and is able to

identify and manage priorities between studies

Level 1 Level 2 Level 3 Level 4 Level 5

Theme 4 – Data Management

Competency 4A: Data Protection

4A: Apply the principles of data protection and secure handling of data

Knowledge

Skills & Behaviours

• Local and national policies and procedures relating to data collection, storing and secure transfer including:

- Data Protection Act 1998

- Confidentiality NHS Code of Practice - Caldicott report & local Caldicott guardian - Freedom of Information Act 2000

• Maintaining confidentiality for patients in clinical trials

• Actions required when data protection processes are not adhered to

• Respects patient and participant confidentiality • Ensures participant confidentiality is maintained

• Takes responsibility for the safe and secure storage of data • Raises concerns about poor data storage

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Identify own role in maintaining confidentiality and protecting data • Contributes to the safe and secure

storage of data by returning documents to their storage location after use

• Identify and describe measures taken in your own research area to maintain confidentiality of data

• Consistently adheres to requirements to protect confidentiality and data • Raises concerns when processes to

ensure confidentiality are not adhered to

• Demonstrates leadership by:

- Ensuring processes and procedures for ensuring participant

confidentiality are developed and adhered to by all members of the research team

Theme 4 – Data Management

Competency 4A: Data Protection

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 4 – Data Management

Competency 4B: Essential Documents

4B: Identify and appropriately utilise essential documents in the conduct of research studies

Knowledge

Skills & Behaviours

• Title, purpose and storage location of essential documents include: source documents, Protocol, Case Report Forms (CRF), Investigator Brochure, Regulatory approvals, information given to subjects, screening log, subject ID log, agreements, reports, communications (E6 section 8(

• Version Control & document tracking

• Establish trial site files compliant with research governance and GCP requirements

• Maintain and update essential documents in the site file

• Recognises the importance of accurate and comprehensive documentation and source data verification

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Can identify and discuss the purpose of key research documents (site files, CRFs, investigator brochure, source data)

• Assists in creating and maintaining research files according to local SOPs

• Describe the purpose and provide examples of essential documents • Raises concerns if incomplete,

inaccurate or misleading documentation is identified • Demonstrates the use of correct

versions of documentation and implements document tracking according to local SOPs

• Creates and maintains research files according to local SOPs

• Responds to concerns if inaccurate or incomplete documentation is identified

• Demonstrates leadership by: - Acting as a knowledgeable

resource for staff

- Meeting the supervision and educational needs of research staff utilising essential documents - Ensuring processes, policies and

SOPs are developed and reviewed to support compliance with

Theme 4 – Data Management

Competency 4B: Essential Documents

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 4 – Data Management

Competency 4C: Data & CRF Completion

4C: Demonstrate accurate data capture and Case Report Form completion including timely submission of data

Knowledge

Skills & Behaviours

• Data media (paper based / web-based / audio / images etc) • Accurate completion of CRFs (paper & electronic)

• Source document verification (SDV)

• IT systems: Trust & sponsor specific applications; Microsoft Office applications; database applications

• Submission of recruitment figures to relevant bodies including NIHR recruitment data

• Transcribe / export data from medical records (paper / electronic) to CRFs (paper / electronic)

• Liaise with trial coordinators, research nurses and clinicians to ensure accurate & complete data collection

• Identify and resolve missing data and/or discrepancies in data

• Proficiency in essential IT skills: store, save and manage electronic files; use Trust / Network based IT systems (e.g. patient records; NIHR portal) & sponsor specific applications (e.g. CRFs)

• Recognises the importance of accurate and comprehensive documentation and source data verification

• Shows attention to detail and accurate data recording

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Evidence of accurate data entry • Evidence of accurate and complete data entry demonstrating attention to detail

• Raises concerns and seeks to address incomplete, inaccurate or misleading data entry

• Contributes to the collection and reporting of local recruitment data

• Undertakes and manages the accurate and complete collection of data, and insertion of data into CRFs or other research storage formats • Responds to concerns if inaccurate

or incomplete data entry is identified • Manages the collection and reporting

of local recruitment data

• Demonstrates leadership by: - Undertaking, supervising and

manage the accurate and complete collection / transcription of data. - Disseminates recruitment data as

applicable and contributes to local recruitment strategies to promote effective recruitment in line with local targets

- Ensuring that local policies and SOPs are followed by all member of the research team

Theme 4 – Data Management

Competency 4C: Data & CRF Completion

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent with no

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 4 – Data Management

Competency 4D: Data Quality

4D: Manage data queries and demonstrate an understanding of the role of monitoring, audit and inspection in the maintenance

of data quality

Knowledge

Skills & Behaviours

• Monitoring visits and role of monitor • Audit and inspection

• Audit ready assessments

• Local processes for auditing & monitoring study data • Data queries

• Protocol deviation / violation

• Acknowledges the purpose of monitoring visits and responds to recommendations appropriately

• Organise and prepare visits by trials monitors (as per protocol)

• Liaise with Clinical Trials Units / Coordinating Centres regarding data queries • Check and resolve data queries

• Conduct quality assurance of documentation

• Recognises the importance of accurate and comprehensive documentation and source data verification

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Prepares documents and facilities for monitoring visits

• Contributes to the resolution of data queries

• Identifies errors and inconsistencies between CRFs and source data and seeks to resolve these

• Prepares documents and facilities for monitoring visits and works with study monitor during visit

• Can list the key components of the relevant local SOP

• Responds to data queries in a timely manner and seeks to resolve missing / inconsistent / incomplete data

• Proactively managers errors / inconsistencies between CRFs and source data to avoid data queries • Responds to data queries in a timely

manner and seeks to identify patterns / trends in missing data to prevent recurrence

• Responds to audit / monitoring recommendations

• Contributes to the auditing and monitoring of research studies and proposes recommendations • Demonstrates leadership by:

- Undertaking, supervising and managing the accurate and

complete collection / transcription of data

- Contributing to the development of, and ensuring that local policies and SOPs are followed by all members of the research team

- Proactively monitors the frequency and nature of data queries and seeks to reduce team data query rates

Theme 4 – Data Management

Competency 4D: Data Quality

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 4 – Data Management

Competency 4E: Safety Reporting

4E: Demonstrate an understanding of the principles and process of Adverse Event reporting (AEs, SAEs and SUSARs)

Knowledge

Skills & Behaviours

• Definition of AE / SAE / SUSAR; timelines for reporting to sponsor and host • Preparation of safety reports

• Disease sites; medical terminology and common acronyms • Toxicity assessments

• Recognise the importance of safety reporting in clinical research

• Prepare adverse event forms in liaisin with clinical staff and recognise the importance of ensuring the process continues through to completion

• Work with the research team to ensure safety reporting timelines are adhered to • Communicate an effective and appropriate manner with research staff, subjects

and wider clinical teams

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Is able to discuss the link between adverse event reporting and patient safety

• Define the terms AEs, SAEs, and SUSARs, and give an example of each

• Describes the difference between AEs, SAEs and SUSARs citing examples from practice

• Consistently takes appropriate action (within scope of delegated duties) when an adverse event occurs or is discovered including timely and appropriate referral

• Assists in the preparation of adverse event reports

• Identifies and consistently takes appropriate action (within scope of delegated duties) when an adverse event occurs

• Prepares initial and follow-up adverse event reports in liaison with clinical staff

• Discusses the principle of unblinding and explains local / study specific processes

• Comprehensive understanding of safety reporting requirements in clinical trials

• Demonstrates leadership by: - Providing comprehensive advice &

timely guidance

- Contributing to the supervision and educational needs of research staff involved in safety reporting

Theme 4 – Data Management

Competency 4E: Safety Reporting

Target & Date for Review Evidence of Achievement

Level 1

Aware of competency; understanding of

basic principles

Level 2

Is competent with assistance and

supervision

Level 3

Is competent with supervision

Level 4

Is competent without

assistance/supervision

Level 5

Is competent and is able to assist /

supervise others

Theme 4 – Data Management

Competency 4F: Storage & Archiving

4F: Apply the principles of secure storage and retention of data / study documentation

Knowledge

Skills & Behaviours

• Filing systems

• Site Master File / Essential Documents

• Storage of trial site file, CRFs and Investigator Brochure • Storage of completed consent forms

• Archiving of data following study closure

• Ensure secure filing and storage of study documentation in accordance with research governance requirements

• Recognises the importance of maintaining secure storage & retention of data

Examples of how competence may be demonstrated:

Level 2

Level 3

Level 4

Level 5

• Maintains in-house filing systems • Returns files / data to original storage

location after use

• Contributes to study closure and preparation of documents for archiving

• Plans for the secure storage of data at the end of study

• Demonstrates leadership by: - Providing comprehensive advice &

guidance

- Ensuring processes and SOPs are in place and adhered to