40
Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411 Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager This document is reviewed and updated in line with emerging evidence or local requirements at least every three years ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 1 of 40 Training matrix checklist Part 1 - Core training for ACRC|CCRC NURSING & ASSISTANT PRACTITIONER staff Part 2 - ACRC/CCRC unit specific training Name of staff: …………………………………… Job Title: ……………………………………………. Start date on ACRC|CCRC: ………………….. Name of unit: ……………………………………… ACRC|CCRC Registered Nurses and Assistant Practitioners (AP) are granted four working weeks supernumerary time when they start in post. This is to allow not only for orientation and introduction to staff roles and core working processes, but also to provide time for mandatory training that needs to be achieved within the first month. Instructions This training matrix should be personalised for each individual according to their job role and in which unit they are working. In addition to the core training section please use appropriate ward specific appendix. The direct line manager (or if not available, the Education & Training Manager) will use the Matrix to carry out a training gap analysis for a new starter and to set up an action plan for the individual to achieve their required training. The Training matrix checklist is also designed to give staff the necessary information for them to arrange their ongoing mandatory training. It is the responsibility of each individual staff that the relevant training (listed below) is carried out. This matrix is to be used in conjunction with: 1. ACRC|CCRC/SOP078 Recording of ACRC Staff Training Records 2. ACRC|CCRC/SOP099 Training for ACRC staff (incorporating study specific training) Please ensure that training/competencies achieved have been added onto your training record in Q-Pulse (place a in the QP box when done). Your line manager will make sure that relevant items of your training are entered on the CUH MAPS database.

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

  • Upload
    others

  • View
    4

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 1 of 40

Training matrix checklist Part 1 - Core training for ACRC|CCRC NURSING & ASSISTANT PRACTITIONER staff Part 2 - ACRC/CCRC unit specific training

Name of staff: …………………………………… Job Title: …………………………………………….

Start date on ACRC|CCRC: ………………….. Name of unit: ………………………………………

ACRC|CCRC Registered Nurses and Assistant Practitioners (AP) are granted four working weeks supernumerary time when they start in post.

This is to allow not only for orientation and introduction to staff roles and core working processes, but also to provide time for mandatory

training that needs to be achieved within the first month.

Instructions

This training matrix should be personalised for each individual according to their job role and in which unit they are working.

In addition to the core training section please use appropriate ward specific appendix.

The direct line manager (or if not available, the Education & Training Manager) will use the Matrix to carry out a training gap analysis for a

new starter and to set up an action plan for the individual to achieve their required training. The Training matrix checklist is also designed to

give staff the necessary information for them to arrange their ongoing mandatory training.

It is the responsibility of each individual staff that the relevant training (listed below) is carried out.

This matrix is to be used in conjunction with:

1. ACRC|CCRC/SOP078 Recording of ACRC Staff Training Records 2. ACRC|CCRC/SOP099 Training for ACRC staff (incorporating study specific training)

Please ensure that training/competencies achieved have been added onto your training record in Q-Pulse (place a in the QP box

when done).

Your line manager will make sure that relevant items of your training are entered on the CUH MAPS database.

Page 2: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 2 of 40

Symbols and abbreviations used:

╫ = one off GCP = ICH Good Clinical Practice

AP = Assistant Practitioner MAR = Mandatory Annual Refresher programme for Clinical Staff

CIWP = Corporate Induction Welcome Programme QP = Q-Pulse

CSSIP = Clinical Support Staff Induction Programme QPO = Qualified Practitioner Orientation

CUH = Cambridge University Hospitals POC = Point of Care

DOT = Direct Online Training RN = Registered Nurse

Induction programs for staff new to the Trust only

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Corporate Induction

Welcome Programme

(CIWP)

Y Y Within 2 months* ╫

See Connect2 pages

*book before new staff start to avoid delay

Qualified Practitioners

Orientation (QPO) Y N Within 2 months* ╫

See Connect2 pages

*book before new staff start to avoid delay

Clinical Support Staff

Induction Programme

(CSSIP)

N Y Within 2 months* ╫ See Connect2 pages

*book before new staff start to avoid delay

General Core Mandatory Training (audited by Trust)

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Local Induction Checklist

(CUH ‘New to Trust’ or

‘Transfer within Trust’

form)

Y Y Within first 2 weeks ╫ See Connect2 pages

Page 3: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 3 of 40

General Core Mandatory Training (audited by Trust) continued

Blood Awareness Y N Within 1 month Annual QPO then annually via DOT

Conflict Resolution* Y Y Within 1 month Biennial

Initially at CIWP thereafter via

DOT *formerly part of Corporate Refresher Update via OLM

Equality, Diversity and

Inclusion* Y Y Within 1 month Biennial

Initially at CIWP then via DOT *formerly part of Corporate Refresher Update via OLM

Fire Safety Awareness*

- e-learning Y Y Within 1 month Biennial

Initially at CIWP then via DOT *formerly part of Corporate Refresher Update via OLM

Fire Evacuation - practical Y Y Within 1 month Annual

Initially at QPO or CSSIP;

thereafter it is part of MAR.

Book via HR Learning Central For more information on what MAR programme see “Further Guidance” on page 35

Health and Safety* Y Y Within 1 month Triennial

Initially at CIWP thereafter via

DOT

*formerly part of Corporate Refresher Update via OLM

Health and Safety

Awareness for Managers Y* N Within 1 month Triennial

DOT

*Line managers only

Infection Prevention and

Control* Y Y Within 1 month Biennial

QPO and CSSIP thereafter via

DOT *formerly part of Corporate Refresher Update via OLM)

Information Governance* Y Y Within 1 month Biennial

Initially at CIWP thereafter via

DOT

*formerly part of Corporate Refresher

Update via OLM

Page 4: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 4 of 40

General Core Mandatory Training (audited by Trust) continued

Looking after you* Y Y Within 1 month Biennial

Initially at CIWP thereafter via

DOT *formerly part of Corporate Refresher Update via OLM

Managers Good Practice

Guide to Appraisals Y* N Within 1 month Annual

DOT

*Line managers only

Moving and Handling –

Inanimate Loads* Y Y Within 1 month Biennial

QPO and CSSIP then annually

via DOT *formerly part of Corporate Refresher Update via OLM)

(Patient) Moving and

Handling – e-learning Y Y Within 1 month Annual DOT

(Patient) Moving and

Handling – practical Y Y Within 1 month Annual

Initially at QPO or CSSIP;

thereafter it is part of MAR.

Book via HR Learning Central For more information on what MAR programme see “Further Guidance” on page 35

NEWS (National Early

Warning Scoring System) Y Y Within 1 month Annual DOT

Safeguarding Children

Level 1 Y Y Within 1 month ╫ *

CIWP - please note:

*if Safeguarding Children level

2 should have lapsed, then level 1 needs to be completed again in addition to level 2

Safeguarding Children

Level 2 Y Y Within 1 month Triennial

Initially at QPO (or CSSIP) then

triennially via DOT

Page 5: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 5 of 40

General Core Mandatory Training (audited by Trust) continued

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Safeguarding Vulnerable

Adults Level 1 Y Y Within 1 month Triennial

Initially at CIWP then

triennially via DOT

Safeguarding Vulnerable

Adults Level 2 (incl. Prevent,

MCA & DoLS)

Y Y Within 1 month Triennial Initially at CIWP then via DOT

Security (and Fraud)

Awareness* Y Y Within 1 month Biennial

Initially at CIWP thereafter via

DOT

*formerly part of Corporate Refresher

Update via OLM

Tissue Viability Y Y Within 1 month Annual DOT

Unconscious Bias Y* N Within 1 month ╫ DOT *Line managers only

Page 6: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 6 of 40

Life Support (audited by Trust)

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments

QP

Resuscitation – e-learning Y Y within 1 month Annual DOT (part of MAR for clinical

staff)

Resuscitation - practical

(Adult Basic Life Support)

(BLS)

Y Y Within 1 month Annual

Initially at QPO or CSSIP;

thereafter it is part of MAR.

Book via HR Learning Central For more information on what MAR programme see “Further Guidance” on page 35

Immediate Life Support

(ILS) includes Adult Basic Life

Support Y* N Within 4 months Annual

Application to the CUH

Resuscitation Office

*Depending on role

Trust competencies

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments

QP

Blood Administration

competency Y N Within 3 months ╫

Contact

[email protected]

.uk to book face-to-face

training session

Infection Control No.1 PPE/Barrier Nursing No.3 Management of a PVC

No.4 Management of CVC/PICC No.6 Management of Urinary Catheters No.7 Aseptic Wound dressing

Y

Y*

Within 1 month ╫

QPO and CSSIP if new to the

Trust otherwise with an

infection control trainer

* Competency number 1, 6 and 7 only

Page 7: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 7 of 40

Medical Devices (audited by Trust)

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments

QP

Medical Devices Stop and

Think Y N Within 1 month Triennial DOT

Training Needs Analysis

for Medical Devices

(ward specific)

Y N Within 1 month ╫*

Find latest version on Connect2

or Education and Training

Team. Relevant equipment

only applies. Training for the high risk devices must be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are entered as one skills cluster on MAPS by team leader when completed. Medium and low risk devices are entered on Q-Pulse individually by team leader.

*needs to be re-completed if new version is issued

Non-device training provided by Point of Care Team (audited by Trust)

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments

QP

Urine Drug Testing Y Y Within 1 month ╫ Provided by POC team

Urine Pregnancy Testing Y Y Within 1 month ╫ Provided by POC team

Page 8: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 8 of 40

Venous Access Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Venepuncture incl.

competency declaration Y Y Within 3 months ╫

Nominated ACRC|CCRC staff

using CUH Competency

Package

http://connect/index.cfm?articl

eid=27347

Cannulation incl.

competency declaration

Y Y Within 5 months ╫

Nominated ACRC|CCRC staff

using

CUH Competency Package

http://connect/index.cfm?articl

eid=27347

Drug Administration

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Drug Administration –

Oral, incl. Competency

Declaration

Y N

Should be completed

during preceptorship

in prior CUH post. If

new to the Trust

please consult

Education & Training

Manager

╫ CUH Competency Package

http://connect/index.cfm?articl

eid=27347

Drug Administration – IV

incl. Competency

Declaration

Y N As above ╫ CUH Competency Package

http://connect/index.cfm?articl

eid=27347

Medical Gas Awareness Y N Within 1 month Annual DOT

Page 9: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 9 of 40

Drug Administration (continued)

Medicines Management –

Nurses and ODPs

Y N Within 1 month Annual QPO then annually via DOT

Trust IT Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

e-Hospital Y Y Within 6 weeks ╫

Course dependent on role.

For new starters course during

QPO and CSSIP,

for others via e-Hospital

training team

MUSE training Y* N Within 2 months ╫

By nominated ACRC|CCRC staff

or GE Healthcare trainer

*Team leaders and ECG trainers only

Rover training Y Y Within 6 weeks ╫ e-Hospital training team

Trust Based Appraisal Training (not mandatory by Trust, but stipulated by ACRC)

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Appraisee Awareness (for

staff being appraised) Y Y

Before first appraisal is

due ╫ Via CUH HR Learning Central

Page 10: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 10 of 40

Appraisal Training (for

appraisers) Y* Y*

Before appraising staff

for the first time ╫

Via CUH HR Learning Central

*Depending on role if formally appraising staff

Only mandatory for staff if they are on the “CUH live mentorship register” (audited by the Trust)

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Mentorship Update Y N Annual

CUH e-learning / 1 hour face-

to-face session provided by

ARU

Mentorship Triennial

Review Y N Triennial

CUH mentorship triennial

review package

Specific to working in clinical research: GCP & Consent Training etc.

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

GCP Training (Provided

by NIHR)

Y Y Within 4 week

supernumerary period Biennial

See ACRC|CCRC/SOP096 GCP

training for ACRC/CCRC staff

Consenting in clinical

research – NIHR training

day or in-house provider

Will be locally decided by nurse manager in conjunction with education manager depending

on requirements by the respective study protocol/team

╫ NIHR online consent training or

in-house provider

CV

(using HRA CV template)

Y Y Within 1 week of GCP

training Biennial

Print out form via Q-Pulse

(ACRC|CCRC/SOP078

Recording of ACRC|CCRC Staff

Training Records)

Page 11: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 11 of 40

ACRC|CCRC In-House Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Q-Pulse Training –

documents and own

training records

Y Y Within 1 month ╫ ACRC|CCRC QA Manager

ACRC|CCRC new staff

Formal Induction

Programme

Y Y Within 6 weeks ╫ Education & Training Team

Introduction to Using

Flowsheets Y Y Within 1 month ╫ Education & Training Team

Introduction to Writing

Flowsheets incl.

Competency

Y N Within 4 months ╫ Education & Training Team

Introduction to Flowsheet

Peer Reviewing incl.

Competency

Y* N Within 6 months ╫ Education & Training Team

*Depending on role

Study Set-Up Training –

attending presentation

session

Y Y Within 1 month ╫ Education & Training Team

Study Set-up Training –

hands-on Y N Within 3 months ╫ Education & Training Team

Page 12: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 12 of 40

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Competency Framework

for Clinical Research

Nurses

Y N Within 9 months ╫ Education & Training Team

Emergency Simulation

Training Y Y within 12 months Annual Education & Training Team

ACRC|CCRC Sample Handling Training / Laboratory Competencies

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Introduction to Health &

Safety in the ACRC|CCRC

sample handling rooms

Y Y Within 1 month ╫ Nominated ACRC|CCRC staff

Centrifuge Competency Y Y Within 6 weeks ╫ Nominated ACRC|CCRC staff

Dry Ice Training Y

Y Within 6 weeks ╫ Nominated ACRC|CCRC staff

Pipette Competency Y Y Within 6 weeks ╫ Nominated ACRC|CCRC staff

Tutella Y Y Within 3 months ╫ Nominated ACRC|CCRC staff

Blood slide training* Y Y

*provided there are

studies which require

this skill

within 8 weeks

╫ Sample handling coordinator or

Nominated ACRC|CCRC staff

Page 13: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 13 of 40

Unit specific appendix - CCRC Level 2

Medical Devices as stipulated by CUH

Name of Training RN AP RA Completion

Period

Renew

Period Provider (and clarification)

Date /

Comments QP

Completion of medical devices training as specified on Training Needs Analysis for Medical Devices on CCRC L2

Y Y N within 1 month ╫

Find latest version on Connect2 or via Education & Training Team. Relevant equipment only applies. Training for the high risk devices must be individually recorded in Q-Pulse by team leader and on MAPS by

device trainer. Medium and Low Risk devices are entered as one skills cluster on MAPS by team leader when completed. Medium and low risk devices are entered on Q-Pulse individually by team leader.

*needs to be re-completed if

new version is issued

Food / Kitchen Training

Reheating food safety awareness

Y Y Y within 2 months ╫

Nominated ACRC|CCRC person during induction programme

Additional Skill required for Sample Handling Room on CCRC level 2

Biomat® 2, Class II

Microbiological Safety

Cabinet

Y Y Y

to have completed before study starts that requires use of this equipment

In–house by nominated person.

Training is linked to ACRC|CCRC/SOP079 ‘Use of Class 2 safety cabinet’ and ‘ACRC/CCRC Form121’

Page 14: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 14 of 40

Endoscopy Training

Name of

Training Description RN AP RA

Completion

Period

Renew

Period Provider

Date /

Comments QP

Part 1: General

Introduction

1. Introduction to the endoscopy rooms

2. the generic pathway of an endoscopy patient

Y Y Y within 1 month ╫ in house by

nominated staff

Part 2: Safety in the endoscopy room – not

involving equipment

1. Completing CUH endoscopy pre assessment form Y Y N

within 1 month

╫ in house by nominated staff

2. Checking written consent for procedure and for research

Y Y N ╫ in house by nominated staff

3. WHO patient safety check

Y Y N ╫ in house by nominated staff

4. Airway management, e.g. head holding, suctioning

Y Y N ╫ in house by nominated staff

5. Endoscopy emergency algorithm Y N N ╫

in house by nominated staff

and at EST/ESD

6. Safe use of pericitic acid (e.g. spillage) Y Y Y ╫

in house by nominated staff and at EST/ESD

Part 3: Safe use of equipment used for

endoscopic

procedures on CCRC Level

1. Olympus Endoscopes training

includes: scope construction, function, reprocessing, cleaning, manual washing, tractability, handling

Y Y Y within 2 months ╫

company rep and reinforced by in-house named staff

2. Olympus Endoscopes setting-up for study

Y Y Y within 2 months ╫ in house

3. Endoscope Preprocessor ("washer")

Y Y Y within 2 months ╫ company rep

Page 15: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 15 of 40

Part 3 continued: Safe use of equipment used

for endoscopic procedures on CCRC Level 2

4. Endoscope Dryer ("endoscopy storage cabinet"):

- Safety and layout

- Use of tags

- Booking in/out - Loading/unloading of scopes

- Importance of traceability paper

- Maintenance

Y

Y

Y within 2 months ╫ in house by nominated staff

5. Endoscope stack for gastroscopy/colonoscopy: - Setting up - Calibration of scopes

a. white balancing b. trimodal calibration

Y Y N within 2 months ╫ company rep

6. Endoscope stack for Endoscopic Ultrasound (EUS) - by Pentax

- setting up and white balancing

Y Y N within 2 months ╫ company rep

7. ERBE Argon Plasma Coagulation (APC):

- setting up

- application of pads - changing programmes

- maintenance

- use of APC when assisting (CUH procedure number…)

Y N N within 2 months ╫ in house by

nominated staff

8. Reverse Osmosis System (ROS): - main panel function - on screen information - water spill (ACRC/SOP….) - weakly checks - servicing - changing internal filter

Y Y Y within 2 months ╫ company rep

9. Olympus Flushing Pump 2: - turning on - connecting tubing and water bottles - adjusting water flow

Y Y N within 2 months ╫ in house by nominated staff

Page 16: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 16 of 40

Name of

Training

Description RN AP RA

Completion

Period

Renew

Period Provider

Date /

Comments QP

Part 3 continued: Safe use of equipment used

for endoscopic procedures on CCRC Level 2

10. EndoFaster by NisoBiomed: - turning on and off - calibration of probes - changing solutions - maintenance

Y Y N within 2 months

╫ company rep

11. Radio Frequency Ablation (RFA) machine:

- safety - setting up - familiarization to probes numbers 360,

90, 60, Express, TTS, Ultra provided by CUH main endoscopy - additional accessories

Y N N within 2 months

╫ company rep

12. Endoscope Guide machine: - safety

- setting up Y Y N

within 2 months

╫ in house by nominated staff

13. Gases used in Endoscopy -

ENTONOX and OXYGEN and CO2 - safety

- setting up

- usage

Y

partly N

within 2 months

╫ in house by nominated staff

14. INR machine - CoagChek XS Plus

Y Y N within 2 months

╫ by Point of Care

15. Study specific Laptop: - storage of data in this device

- safety Y Y N

within 2 months

╫ by research study team

Page 17: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 17 of 40

Name of

Training

Description RN AP RA

Completion

Period

Renew

Period Provider

Date /

Comments QP

Part 4:

Assisting with endoscopic procedures/

interventions on CCRC L2

Taking biopsy samples Y N N

within 2 months

╫ by research study team

Assist with Fine Needle Aspiration in EUS

Y N N tbc ╫ by research study team

Assisting with dilatation

Y N N tbc ╫ by research study team

Assisting with Endoscopic Mucosal Resection (EMR) Y* N N

*depends on

availability of training

*requires

complex and lengthy training

Emergency haemostasis Y* N N

*depends on availability of training

*requires complex and lengthy training

Part 5:

Recovery knowledge and skills

In accordance with CUH procedures:

Post sedation recovery Post EMR recovery

Post RFA recovery

Y

Y N within 2 months

╫ in-house by nominated staff

Page 18: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 18 of 40

Study Specific Training

Name of Training RN AP RA Completion

Period

Renew

Period

Provider (and

clarification)

Date /

Comments QP

EMR Captivator study specific (disposable):

- safety

- setting up

Y Y N within 2 months ╫ by research study team

Confocal Stack and probes by Cellvizio:

- safety (e.g. laser)

- types of probes

- limitation of uses

- handling of probes - (re)processing of probes

- setting up

- maintenance

Y N N within 2 months ╫ in-house by nominated staff

Assist with Confocal probe imaging - oesophageal imaging

- pancreatic imaging

Y N N within 3 months ╫ by research study team of the relevant study/company

rep of probe used

Consent BioResource – adults Y* Y* N Not before third month, but within 5 months

BioResource team and ACRC|CCRC education team combined

*Only staff on delegation log

for relevant study

Page 19: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 19 of 40

Endoscopy Annual Refresher Training

Name of Training Description RN AP RA Completion Period

Renew Period

Provider Date /

Comments QP

Endoscopy Annual Refresher covering safe use of the following equipment

Part 1 - all members of the team

1.Endoscope Preprocessor ("washer")

2.Safe use and maintenance of Reverse Osmosis System (ROS)

Y Y Y at annual endoscopy team

update training

annually or when there is

an upgrade

to equipme

nt

in-house by team leader

Part 2 – RNs and AP only

3.Endoscope stack

4.Endoscopes (all types)

5.EUS machine

6.ERBE machine

7.RFA machine

8.ENDOFaster machine

9.INR machine

Y Y N at annual endoscopy team update training

annually or when there is

an upgrade

to equipme

nt

in-house by team leader

Endoscopy Annual Refresher

Safe use of pericitic acid (e.g.

spillage)

included in Emergency Skills Drill

(ESD) training

Y Y Y at ESD training

on CCRC level 2 annually

ACRC/CCRC education team and team leader

does not require separate recording on Q-Pulse

Page 20: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 20 of 40

Unit specific appendix - CCRC L3 IT training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

e-Hospital Beacon training Y N Within 2 months ╫ Nominated ACRC|CCRC person

Systemic Cancer Therapies

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Chemotherapy Collector

competency

Y Y Within 3 months Annual

Guidance on completion and

competency assessment

provided by ACRC|CCRC

Chemo assessors

Chemotherapy Checker

competency

Y N Within 6 months Annual

Guidance on completion and

competency assessment

provided by ACRC|CCRC

Chemo assessors

Chemotherapy Giver

competency

Y N Within 14 months Annual

Guidance on completion and

competency assessment

provided by ACRC|CCRC

Chemo assessors

Monoclonal Antibody

session Y N Within 3 months ╫

Part of Formal Induction

Program facilitated by the

Education Team

Page 21: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 21 of 40

Venous Access Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Portacath

access/maintenance Y N Within 14 months ╫ CUH venous access trainer

PICC line care Y N Within 14 months ╫ CUH vascular access team and

DOT training package

Medical Devices as stipulated by CUH

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Completion of medical

devices training as

specified on

Training Needs Analysis

for Medical Devices on

CCRC L3

Y N Within 1 month ╫*

Find latest version on Connect

or Education and Training

Team. Relevant equipment

only applies. Training for the

high risk devices must be

individually recorded in Q-Pulse

by team leader and on MAPS

by device trainer. Medium and

Low Risk devices are entered

as one skills cluster on MAPS

by team leader when

completed. Medium and low

risk devices are entered on Q-

Pulse individually by team

leader.

*needs to be re-completed if

new version is issued

Page 22: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 22 of 40

Additional Skill required for Sample Handling Room on CCRC level 3

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Biomat® 2, Class II

Microbiological Safety

Cabinet

Y Y

to have completed before study starts that

requires use of this equipment

In–house by nominated person.

Training is linked to

ACRC|CCRC/SOP079 ‘Use of Class 2 safety cabinet’ and ‘ACRC/CCRC Form121’

Food / Kitchen Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Reheating food safety

awareness

Y Y within 2 months ╫ Nominated ACRC|CCRC person

during induction programme

Page 23: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 23 of 40

Study Specific Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

ECG ELI 150 Rx Mortara

(CIW294)

Y Y Before study starts ╫

Member of study team or

Sponsor (e-learning with

certificate)

http://ehealthheducation.ert.co

m/knav/nav. Curriculum ID

Hm7745656

Mortara 24 Hour Holter

Monitor

(CIW294)

Y N Before study starts ╫ Member of study team and

DVD

Consent BioResource –

adults Y* Y*

Not before third month, but within 5 months

BioResource team and

ACRC|CCRC education team

combined

*Only staff on delegation log

for relevant study

Page 24: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 24 of 40

Unit specific appendix - CCRC L4 Medical Devices as stipulated by CUH

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Completion of medical

devices training as

specified on

Training Needs Analysis

for Medical Devices on

CCRC L4

Y N Within 1 month ╫*

Find latest version on Connect

or Education and Training

Team. Relevant equipment

only applies. Training for the

high risk devices must be

individually recorded in Q-Pulse

by team leader and on MAPS

by device trainer. Medium and

Low Risk devices are entered

as one skills cluster on MAPS

by team leader when

completed. Medium and low

risk devices are entered on Q-

Pulse individually by team

leader.

*needs to be re-completed if

new version is issued

Page 25: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 25 of 40

Food / Kitchen Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Food Safety Certificate –

(level 1 equivalent) Y Y Within 2 months Triennial

Arranged via the ACRC|CCRC

research technician (dietetics)

or online course

Kitchen Competency -

Diet Kitchen Y Y Within 2 months ╫

ACRC|CCRC dietetic research

technician

Study Specific Training

Name of Training CRN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

MRI Safety Certificate

(CRFS002, CRF179,

CRF187, CRF319,

CRF374)

Y N Before study starts ╫ Book with WBIC staff

GastroCH4ECK portable

Gastrolyzer

(CRF387)

Y N Before study starts ╫ Member of study team and

user manual

Skin Biopsy Training incl.

Competency

(CRF001)

Y N Before study starts ╫ Nominated ACRC|CCRC staff or

study team of the relevant

study

Page 26: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 26 of 40

Study Specific Training continued

Name of Training CRN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Actiheart Y N Before study starts ╫ Study team

Motionwatch Y N Before study starts ╫ Study team

SomnoScreen plus PSG Y N Before study starts ╫ Study team

Use of Class 2 Safety

Cabinet incl. Competency

(CRF267)

Y N Before study starts ╫ Nominated ACRC|CCRC staff

Linked to ACRC|CCRC/SOP079

Use of Class 2 safety cabinet

Page 27: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 27 of 40

Unit specific appendix - CCRC L5 Trust IT training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

e-Hospital Beacon training Y N Within 2 months ╫ Nominated ACRC|CCRC person

Systemic Cancer Therapies

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Complete part 1 and 2 of

the chemotherapy

workbook

Y N Within 3 months ╫ Guidance provided by

ACRC|CCRC chemotherapy

assessors

CUH Chemotherapy

Workshop Y N Within 12 months ╫

Guidance provided by

ACRC|CCRC chemotherapy

assessors.

Monoclonal Antibody

session Y N Within 3 months ╫

Part of Formal Induction

Program facilitated by the

Education Team

Page 28: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 28 of 40

Venous Access Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Portacath

access/maintenance Y N Within 14 months ╫ CUH venous access trainer

PICC line care Y N Within 14 months ╫ CUH vascular access team and

DOT training package

Medical Devices as stipulated by CUH

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Completion of medical

devices training as

specified on

Training Needs Analysis

for Medical Devices on

CCRC L5

Y N Within 1 month ╫*

Find latest version on Connect

or Education and Training

Team. Relevant equipment

only applies. Training for the

high risk devices must be

individually recorded in Q-Pulse

by team leader and on MAPS

by device trainer. Medium and

Low Risk devices are entered

as one skills cluster on MAPS

by team leader when

completed. Medium and low

risk devices are entered on Q-

Pulse individually by team

leader.

*needs to be re-completed if

new version is issued

Page 29: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 29 of 40

Study Specific Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

ECG ELI 150 Rx Mortara

(CRF402, CRF453 and

CRF448)

Y* Y* Before study starts ╫

Member of study team or study

link coordinator (e-learning

with certificate)

http://ehealthheducation.ert.co

m/knav/nav. Curriculum ID

Hm7745656

*Depending on study allocation

Mortara 24 Hour Holter

Monitor

(CRF402)

Y* N Before study starts ╫

Member of study team or study

link coordinator and DVD

*Depending on study allocation

Lifecard Holter Monitor

(CRF441)

Y* N Before study starts ╫ Member of study team

*Depending on study allocation

Telemetry Phillips

(CRF441)

Y* N Before study starts ╫

Member of study team or

Philips trainer and DVD. Linked

to ACRC|CCRC SOP077 Use of

telemetry equipment

*Depending on study allocation

Page 30: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 30 of 40

Study Specific Training (continued)

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

CareFusion Micro 1

Spirometer incl.

competency

(CRF471)

Y* N N Before study starts ╫

Practical session in Pulmonary

Lung Function Clinic and

competency assessment by

local trainer. Linked to

ACRC|CCRC/SOP115

CareFusion Micro I Spirometer

*Depending on study allocation

Nasogastric Tube incl.

Competency

(CRF025)

Y* N Before study starts ╫

Trust trainer or nominated

ACRC|CCRC staff

* Only required by staff who

work on wards that care for

patients with NG tubes.

Clarified in PDN meeting on

20 Jan 2016

Care of Tracheostomy

Patient incl. Competency

(CRF025)

Y* N Before study starts ╫

CUH Tracheostomy Nurse or

nominated ACRC|CCRC in-

house trainer

*Depending on study allocation

Flowcare Pump training

(CRF025) Y* N Before study starts ╫

Face to face training with link

trainer or Nutricia rep incl DVD

*Depending on study allocation

Page 31: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 31 of 40

Study Specific Training (continued)

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Glasgow Coma Scale

(CRF025) Y* N Before study starts Biannual

Nominated ACRC|CCRC staff

*Depending on study allocation

Volumetric IV pump -

Baxter Folly Fuser

(CRF441)

Y* N

Post completion of IV

Pack and before study

starts

╫ Nominated ACRC|CCRC staff

*Depending on study allocation

Skin Biopsy Training incl.

Competency

(CRF311)

Y* N Before study starts ╫

Nominated ACRC|CCRC staff or

study team of the relevant

study

*Depending on study allocation

MRI Safety Certificate

(CRF025 and CRF209) Y * N Before study starts ╫

Book with WBIC staff

*Depending on study allocation

Consent BioResource –

adults Y* Y*

Not before third month,

but within 5 months ╫

BioResource team and

ACRC|CCRC education team

combined

*Only staff on delegation log

for relevant study

Page 32: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 32 of 40

Food / Kitchen Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Reheating food safety

awareness Y Y within 2 months ╫

Nominated ACRC|CCRC person

during induction programme

Page 33: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 33 of 40

Unit specific appendix ACRC L3 (CIW) Trust IT training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

e-Hospital Beacon training Y N Within 2 months ╫ Nominated ACRC|CCRC person

Systemic Cancer Therapies

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Chemotherapy Collector

competency

Y Y Within 3 months Annual

Guidance on completion and

competency assessment

provided by ACRC|CCRC

Chemo assessors

Chemotherapy Checker

competency

Y N Within 6 months Annual

Guidance on completion and

competency assessment

provided by ACRC|CCRC

Chemo assessors

Chemotherapy Giver

competency

Y N Within 14 months Annual

Guidance on completion and

competency assessment

provided by ACRC|CCRC

Chemo assessors

Monoclonal Antibody

session Y N Within 3 months ╫

Part of Formal Induction

Program facilitated by the

Education Team

Page 34: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 34 of 40

Venous Access Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Portacath

access/maintenance

Y N Within 14 months ╫ CUH venous access trainer

PICC line care Y N Within 14 months ╫

CUH vascular access team and

DOT training package

Medical Devices as stipulated by CUH

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Completion of medical

devices training as

specified on

Training Needs Analysis

for Medical Devices on

ACRC level 3 - CIW

Training Needs

Y N Within 1 month ╫*

Find latest version on Connect

or Education and Training

Team. Relevant equipment

only applies. Training for the high risk devices must be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are entered as one skills cluster on MAPS by team leader when completed. Medium and low risk devices are entered on Q-Pulse individually by team leader. *needs to be re-completed if new version is issued

Page 35: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 35 of 40

Study specific training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Laptop Aliquot Scanner

incl e-document

(CRF313)

Y Y Before study start ╫ Nominated ACRC|CCRC person

or study team

Skinfold measurement

(CRF313) Y Y Before study starts ╫

Member of study team

Use of Class 2 Safety

Cabinet incl. Competency

(CRF267)

Y N Before study starts ╫ Nominated ACRC|CCRC staff

Linked to ACRC|CCRC/SOP079

Use of Class 2 safety cabinet

Consent BioResource –

adults Y* Y*

Not before third month, but within 5 months

BioResource team and

ACRC|CCRC education team

combined

*Only staff on delegation log

for relevant study

Food / Kitchen Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Reheating food safety

awareness Y Y within 2 months ╫

Nominated ACRC|CCRC person

during induction programme

Page 36: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 36 of 40

Unit specific appendix - ACRC L5 (CRF)

Paediatric skills

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Paediatric Competency Y Y Within 1 month ╫ Nominated ACRC|CCRC

paediatric nurse. Refreshers at

annual team day.

Paediatric Immediate Life

support

(PILS)

Y* N Within 4 months Annual CUH Resuscitation Team

*Paediatric nurses only

Paediatric Life support

(PBLS) Y Y Within 3 months Annual

Part of MAR

Tutor led learning via HR

Learning central combined with

online learning via DOT

For more information on what

MAR programme see “Further

Guidance” on page 35

Consenting issues in

paediatric research -

NIHR online course

Y Y Within 10 weeks ╫ NIHR CRN Learn – online

Specific to ACRC level 5

Freezerworks Training Y* Y* Within 10 weeks ╫ Nominated ACRC|CCRC staff

*Depending on role

Page 37: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 37 of 40

Medical devices as stipulated by CUH

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Completion of medical

devices training as

specified on

Training Needs Analysis

for Medical Devices on

ACRC L5 (CRF)

Y N Within 1 month ╫*

Find latest version on Connect

or Education and Training

Team. Relevant equipment

only applies. Training for the

high risk devices must be

individually recorded in Q-Pulse

by team leader and on MAPS

by device trainer. Medium and

Low Risk devices are entered

as one skills cluster on MAPS

by team leader when

completed. Medium and low

risk devices are entered on Q-

Pulse individually by team

leader.

*needs to be re-completed if

new version is issued

Study specific training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

MRI Safety Certificate

(CRF149, CRF308,

CRF356, CRF400,

CRF412, CRF462,

CRF472)

Y N Before study starts ╫ Book with WBIC staff

Page 38: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 38 of 40

Study specific training continued…

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

DexCom G4 Continuous

Blood Glucose Monitor

(CRF473)

Y N Before study starts ╫ Member of study team and

user manual thereafter study

link coordinator

Use of Class 2 Safety

Cabinet incl. Competency

(CRF473)

Y Y Before study starts ╫ Nominated ACRC|CCRC staff

Linked to ACRC|CCRC/SOP079

Use of Class 2 safety cabinet

Skin Biopsy Training incl.

Competency

(CRF447) Y N Before study starts ╫

Nominated ACRC|CCRC staff or

study team of the relevant

study

Consent BioResource –

adults Y* Y*

Not before third month,

but within 5 months ╫

BioResource team and

ACRC|CCRC education team

combined

*Only staff on delegation log

for relevant study

Page 39: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 39 of 40

Food / Kitchen Training

Name of Training RN AP Completion Period Renew

Period Provider (and clarification)

Date /

Comments QP

Food Safety Certificate –

(level 1 equivalent) Y Y Within 2 months Triennial

Arranged via the ACRC|CCRC

research technician (dietetics)

or online course

Kitchen Competency -

Diet Kitchen

Y Y Within 2 months ╫ ACRC|CCRC dietetic research

technician

Page 40: Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC ... · be individually recorded in Q-Pulse by team leader and on MAPS by device trainer. Medium and Low Risk devices are

Addenbrooke’s Clinical Research Centre (ACRC) Box 127 ACRC|CCRC/FRM085 Cambridge Clinical Research Centre (CCRC) Box 411

Ensure you are using the current version of this document. Notify any changes required to the relevant QA Manager

This document is reviewed and updated in line with emerging evidence or local requirements at least every three years

ACRC|CCRC/FRM085 version 4 Approved: 21/04/2017 Page 40 of 40

Further Guidance

Name of training Who? How often? Provider?

Mandatory Annual Refresher (MAR) for clinical staff - Option A

Part 1 - Clinical e-learning (Nurse) Fire Safety Awareness Resus (adult) Moving & Handling of patients

Nurses who only require basic life support training and who work with adult participants only

Annual - The e-leaning and tutor-led hands-on training should be done within 7 days of each other

Trust e-learning package via DOT

Part 2 - Tutor led training MAR Program A comprising: - Adult Basic Life Support - practical - Safe patient handling – practical - Fire training and evacuation – practical

Tutor-led hands on session to be booked well in advance with HR Learning Central Ask for: MAR Programme A

Mandatory Annual Refresher (MAR) for clinical staff - Option D

Part 1 - Clinical e-learning (Nurse) Fire Safety Awareness Resus (paeds and adult) Moving & Handling of patients

Nurses working with adults and children

Annual – The e-leaning and tutor-led hands-on training should be done within 7 days of

each other

Trust e-learning package via DOT

Part 2 - Tutor led training MAR Program D comprising: Adult Basic Life combined with Paeds Basic Life Support - hands on

- Safe patient handling – hands on - Fire training and evacuation – hands on

Tutor-led hands on session to be booked well in advance with HR Learning Central Ask for: MAR Programme D

Mandatory Annual Refresher (MAR) for clinical staff - Option E

Part 1 - Clinical e-learning (Nurse) Fire safety Awareness Resus (adult) Moving & Handling of patients

Nurses who undertake ILS training and who work with adult participants only

Annual - The e-leaning and tutor-led hands-on training should be done within 7 days of each other

Trust e-learning package via DOT

Part 2 - Tutor led training MAR Program E comprising: - Safe patient handling – hands on - Fire training and evacuation – hands on - (note: this programme does not contain resus)

Tutor-led hands on session to be booked well in advance with HR Learning Central Ask for: MAR Programme E