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Study Documents

Below you will find relevant documentation for the Perioperative Quality Improvement Programme. This page will be updated as and when new documents become available. If you have any queries please do not hesitate to contact us at pqip@rcoa.ac.uk

NIHR Portfolio: 

CPMS ID 32256

 

 

 

 

How To Get Involved

How to make the most of PQIP - Introduction Pack for Local Teams
Engagement Certificate

Job Descriptions

Local PQIP Team Job Descriptions

PQIP Presentations

Introduction to PQIP for Local Teams 

PQIP Eligible Procedures

List of Procedures

Protocols

PQIP Database Protocol v1.2
PQIP Patient Study Protocol v2.1


PQIP Local Team Action Timeline

Data Collection Flowchart 

Data Collection Forms 

Case Report Form v2.6 (.docx for site localisation)
Case Report Form v2.6 (PDF) 

Scripts for Follow-Up Calls

6-month Follow-Up Script
12-month Follow-Up Script 


Standard Operating Procedures

Standard Operating Procedures (.docx for site localisation)
Standard Operating Procedures (PDF)


Patient Invitation Letter

PQIP Patient Participation Invitation Letter v4 03.07.2020

Patient Forms

Consent Form v1.8 (PDF)
Consent Form v1.8 (.docx for site localisation)

Patient Questionnaire Booklet

Patient Information Sheet v1.5 (PDF)
Patient Information Sheet v1.5 (.docx for site localisation)

PQIP Patient Study Poster


Health Research Authority: Ethics Approval

PQIP Research Database Ethics Approval Letter
PQIP Patient Research Study REC Approval Letter
PQIP Patient Study HRA Approval Letter
PQIP Patient Study IRAS Form
PQIP Patient Study Organisation Information Document (OID)
PQIP Patient Study Schedule of Events 

Caldicott Guardian Agreement Form

Insurance Information

UCL Insurance Policy 2025-26
UCL Insurance Letter of Confirmation 


Amendments to the Study

Substantial Amendments

1.0
Notice of Substantial Amendment 1.0
Categorisation of Substantial Amendment 1.0 
REC Approval of Substantial Amendment 1.0 26.10.2016
HRA Approval of Substantial Amendment 1.0  27.10.2016

2.0
Notice of a Substantial Amendment 2.0  01.12.2016
Categorisation of Substantial Amendment 2.0  23.12.2016
Acknowledgement of Substantial Amendment 2.0  19.12.2016
REC Approval of Substantial Amendment 2.0 05.01.2017
HRA Approval of Substantial Amendment 2.0 30.01.2017

3.0 
Notice of Substantial Amendment 3.0 28.03.2017
REC Approval of Substantial Amendment 3.0 28.06.2017
HRA Approval of Substantial Amendment 3.0 19.07.2017

4.0
Notice of Substantial Amendment 4.0 20.10.2017
REC Approval of Substantial Amendment 4.0 26.12.2017
HRA Approval of Substantial Amendment 4.0 

5
.0
Notice of Substantial Amendment 5.0 13.02.2019
Categorisation of Substantial Amendment 5.0 17.03.2019
Acknowledgement of Substantial Amendment 5.0 17.03.2019
REC Approval of Substantial Amendment 5.0 20.03.2019
HRA Approval of Substantial Amendment 5.0 27.03.2019

6.0

Amendment Tool for Substantial Amendment 6.0 17.08.2020 (includes Categorisation)

REC Approval of Substantial Amendment 6.0 14.09.2020

HRA Approval of Substantial Amendment 6.0 14.09.2020

7.0
Amendment Tool for Substantial Amendment 7.0 18.08.2023 
REC Approval of Substantial Amendment 7.0 18.08.2023
HRA Approval of Substantial Amendment 7.0 18.08.2023 

8.0

This planned amendment (Substantial Amendment 8.0 24.11.2024) pertained to the sickness leave of the study CI. The amendment did not progress past the JRO's approval as our CI had already returned from leave by the time of it's approval. No REC or HRA validation was pursued. This was not submitted via IRAS. 

No impact to the running of the study by PQIP sites was identified and so publication of administrative process was nixed. We apologise for any confusion caused by the numbering of the subsequent SA.

9.0
Amendment Tool for Substantial Amendment 9.0 23.07.2025
REC Approval of Substantial Amendment 9.0 23.07.2025
HRA Approval of Substantial Amendment 9.0 23.07.2025

Non-Substantial Amendments

NSA1

 Notice of Minor Amendment 1.0 27.10.2016

Categorisation Confirmation for Minor Amendment 1.0 15.11.2016

NSA2

 Notice of Minor Amendment 2.0 01.12.2016

Categorisation of Minor Amendment 2.0 09.01.2017

NSA3

Notice of Minor Amendment 3.0 02.02.2017
Categorisation of Minor Amendment 3.0 16.02.2017

NSA4

Notice of Minor Amendment 4.0 02.03.2017
Categorisation Confirmation of Minor Amendment 4.0 02.03.2017

NSA5

Notice of Minor Amendment 5.0 19.06.2017
Categorisation of Minor Amendment 5.0 30.06.2017

NSA6

Notice of Minor Amendment 6.0 17.07.2017
Categorisation of Minor Amendment 6.0 04.08.2017

NSA7

Notice of Minor Amendment 7.0 11.08.2017
Categorisation of Minor Amendment 7.0 25.08.2017

NSA8

Notice of Minor Amendment 8.0 08.12.2017
Categorisation of Minor Amendment 8.0 15.12.2017 

NSA9

Notice of Minor Amendment 9.0 16.02.2018
Categorisation of Minor Amendment 9.0 28.02.2018

NSA10

Notice of Minor Amendment 10.0 10.08.2018
Categorisation of Minor Amendment 10.0 31.08.2018

NSA11

Notice of Minor Amendment 11.0 29.10.2018
Categorisation of Minor Amendment 11.0 03.12.2018

NSA12

Notice of Minor Amendment 12.0 21.01.2019
Categorisation of Minor Amendment 12.0 08.03.2019

NSA13

Notice of Minor Amendment 13.0 24.05.2019
Categorisation of Minor Amendment 13.0 21.06.2019

NSA14

Notice of Minor Amendment 14.0 14.10.2019
Categorisation of Minor Amendment 14.0 25.10.2019

NSA15

Notice of Minor Amendment 15.0 17.01.2020
Categorisation of Minor Amendment 15.0 24.03.2020

NSA16

Notice of Minor Amendment 16.0 24.09.2020

 Categorisation of Minor Amendment 16.0 25.09.2020

NSA17

Notice of Minor Amendment 17.0 05.11.2020

Categorisation of Minor Amendment 17.0 05.11.2020 

NSA18

Notice of Minor Amendment 18.0 16.02.2021

Categorisation of Minor Amendment 18.0 16.02.2021

NSA19

Notice of Minor Amendment 19.0 19.07.2021

Categorisation of Minor Amendment 19.0 19.07.2021

NSA20

Notice of Minor Amendment 20.0 06.10.2021

Categorisation of Minor Amendment 20.0 06.10.2021

NSA21

Notice of Minor Amendment 21.0 05.05.2022

Categorisation of Minor Amendment 21.0 05.05.2022

NSA22

Notice of Minor Amendment 22.0 12.07.2022

Categorisation of Minor Amendment 22.0 12.07.2022

NSA23

Notice of Minor Amendment 23.0 01.10.2022

Categorisation of Minor Amendment 23.0 01.10.2022

NSA24

Notice of Minor Amendment 24.0 15.02.2023

 Categorisation of Minor Amendment 24.0 15.02.2023

NSA25

Notice of Minor Amendment 25.0 08.08.2023
Categorisation of Minor Amendment 25.0 08.08.2023

NSA26

Notice of Minor Amendment 26.10.10.2023
Categorisation of Minor Amendment 26.0 10.10.2023

NSA27

Notice of Minor Amendment 27. 28.11.2023
Categorisation of Minor Amendment 27.0 28.11.2023

NSA28

Notice of Minor Amendment 28.0 16.01.2024
Categorisation of Minor Amendment 28.0 16.01.2024

NSA29

Notice of Minor Amendment 29.0 02.09.2024
Categorisation of Minor Amendment 29.0 02.09.2024

NSA30

Notice of Non Substantial Amendment 30.0 13.11.2025
Categorisation of Non Substantial Amendment 30.0 13.11.2025


Information Governance Documents

Information Governance Policy: PQIP v1.2
Information Governance Procedures for PQIP v1.2