PCCIU data – Protocol Template and example specification



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|DOCUMENT NO.: V3.3 |

|EFFECTIVE DATE: 20.12.2018 |

Lothian Research Safe Haven (LRSH)

Project Protocol and Data Specification Form

Contents

1. Details of Applicant(s) 2

Project details 2

2. Project title: 2

3. Lay Summary: 2

4. What is the nature of the project 3

5. Nature and Timescale for Project 3

6. Consent 3

7. Approvals 3

8. Project reference numbers 4

9. Project Funding 4

Project Specification 5

10. Background/rational 5

11. Aim(s) and Objectives 5

12. Study design and methods 5

13. Study population 5

14. Outcomes of interest 5

15. Exposure of interest 6

16. Observational period 6

17. Proposed Analysis 6

18. Peer review 6

Datasets Specification 7

19. Researcher supplied dataset 7

20. LRSH supplied datasets 8

21. Data processing within LRSH 9

22. Which Safe Haven analytic platform is the data to be transferred to? 9

23. Individuals seeking access to linked data in analysis platform 9

Applicant - User Declaration: 11

Post-submission Assessments: 12

Post-review outcome: 12

Details of Applicant(s)

|Principle Applicant | |

|Title and full name: | |

|Email Address: | |

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|Organisation and | |

|Full address: | |

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|Telephone number: | |

|Position held: | |

Principal applicants who are not an NHS or University employee (e.g. student) require the support of an appropriate Proposer, e.g. Head of Department, Clinical Director or Educational Supervisor

|Proposer (if relevant) Title and full | |

|name: | |

|Email Address: | |

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|Organisation and | |

|Full address: | |

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|Telephone number: | |

|Position held: | |

Project details

Project title:

In not more than 25 words

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Lay Summary:

In not more than 150 words

(This may be included the ACCORD/NRS website under projects undertaken)

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What is the nature of the project

i.e. Research (hypothesis testing), service improvement, audit, education, etc.

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Timescale for Project

|Project Start Date: | |Project End Date: | |

|Time Constraints to Note: | |

Consent

Please clarify what consent has been, or will be, obtained from patients/ participants for access to and use of this data.

Please include any relevant text from the consent form/PIL.

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Approvals

Ethical Approval

|Are there any ethical issues associated with the use of the data in|If yes, please explain: |

|your proposed study? | |

|Is there a risk of disclosure of an individual’s identity given the|If yes, please explain: |

|nature of the data in this study (e.g. individuals with rare | |

|diseases)? | |

|Yes/ No /Unsure? | |

Which type of ethical approval is appropriate for your project?

|LRSH generic Research Database REC approval | |

|Project-specific REC approval | |

|Ethical approval not required | |Please explain why: |

|Not known | |Please speak to the LRSH team |

Caldicott or PBPP Approval:

Is Caldicott or PBPP approval being sought, obtained or is not required?

(Please speak to the LRSH team if you are not sure)

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Project reference numbers

Please provide where know or state pending

|R&D: | |

|Other: | |

Project Funding

There is a cost associated with sourcing and/or extracting data for all projects. Please bear this in mind when making your application.

Funding application

|Planned | |Funder / Intended Funder? |

|Applied for | | |

|Awarded | | |

|Existing Funding | | |

|N/A | | |

Nature of funding available for you project

|Commercial: | |Please provide details of the funding available for this activity: |

|Eligible organisation funding: | | |

|Non-Eligible Organisation funding: | | |

|Other, please specify: | | |

|Not funded: | | |

|Not known: | | |

Project Specification

Background/rational

In not more than 500 words - Explain reason for the study and include any other essential background information, e.g. related research. What is the background to the study? Why is the study needed? What are the envisaged benefits to patients or the wider public?

|Background: |

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|Benefits: |

Aim(s) and Objectives

|Aims: |

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|Objectives: |

Study design and methods

Describe type of study, e.g. case-control, cohort or cross-sectional study and the proposed methods

|Study Design: |

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|Methods: |

Study population

Define the data source and study population. Provide criteria on how the study population is going to be drawn from the databases, e.g. Give the exclusion, inclusion criteria and methods of selection of participants. Describe methods of follow-up.

For matched studies, give matching criteria and number of exposed and unexposed

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Outcomes of interest

Clinical outcome of interest

Define clinical outcome of interest. Comment on how the outcome of interest is going to be ascertained, e.g. ICD-10/OPCS codes, first presentation of disease

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Non-clinical outcomes of interest

e.g. prescription, blood pressure measurement. A list should be provided of all other terms or drug codes of interest

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Exposure of interest

Describe exposures e.g. Smoking, Female Gender, Age

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Observational period

Depending on the study design, provide information on the time period you are interested in and whether calendar or financial year/s e.g. all cases of angina in years 2009 to 2012 or 2009-10 to 2012-13

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Proposed Analysis

What are your proposed methods of analysis e.g. logistic regression with adjustment for confounding?

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Peer review

Has the project been independently peer reviewed?

|Yes: | |Please give details: |

|No: | |Why not? |

Datasets Specification

Researcher supplied dataset(s)

Datasets provided by the researcher e.g. audit data.

Please describe the purpose of the dataset, how information was collected, time period it pertains to, name of Data Controller and the variables needed in the linked dataset.

If more than one dataset is provided, please add another table below.

|Researchers’ dataset - 1 |

|What is the name of the dataset? | |

|The purpose for which it was collected | |

|Describe the content of the dataset | |

|The time period to which it pertains | |

|What is the name of the data controller | |

|Describe how patients have been informed of this use of their| |

|data. | |

|File type (e.g. Access, Excel, etc) | |

|The identifying variables which will be provided to the Safe |Forename | |

|Haven to enable linkage (please tick all that apply) | | |

| |Middle name | |

| |Surname | |

| |CHI Number | |

| |Postcode | |

| |Date of Birth | |

| |Gender | |

| |Other (please specify below): |

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|Variables needed from researchers’ dataset 1 in the linked dataset |

|Field name |Data type |Description |Coding of variable |

|e.g. gender |Integer |Patient’s gender |1= male, 2 =female, 3= not |

| | | |known |

|e.g. Trial arm | |Trial Arm for... |Code use.... |

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Please add addition tables to describe other datasets provided by the Researcher

LRSH supplied datasets

Datasets available or to be sought by LRSH.

( Please describe which of the Safe Haven datasets you require and which variables you require)

|If yes, please tick the dataset(s) involved below and indicate the relevant time period: |

| |Tick |Time period |

|SMR00 - Outpatients | | |

|TRAK Oracle - Inpatients and Day Cases | | |

|SMR01 - Inpatients and Day Cases | | |

|SMR02 - Maternity | | |

|SMR04 - Mental Health | | |

|SMR06 - Cancer Registration | | |

|SMR11/SBR - Neonatal/Scottish Birth Record (please specify which) | | |

|CHSP-PS/CHSP-S/SIRS - Child Health Surveillance and Immunisation (please specify which) | | |

|A&E - Accident and Emergency | | |

|PIS - Prescribing Information | | |

|National Audits and Disease Registries eg Surgical Mortality, Renal Registry (please | | |

|specify which) | | |

|Birth, Stillbirth or Death Records (NRS) (please specify which) | | |

|Other (please list below) | | |

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|Variables to be provided in the output file |

|Variable |Data Source |

|e.g. Names of medicines dispensed |PIS |

|e.g. Primary diagnosis (of asthma with ICD 10 code J45, J46) |TRAK |

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Data processing within LRSH

Please provide an outline of the data processing required to be undertaken by LRSH analysts in preparing the (linked) output dataset for analysis.

If updates of this dataset will be required, how frequently will these be required?

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PLEASE INCLUDE A DATA FLOW DIAGRAM AS AN APPENDIX TO THIS DOCUMENT

Which Safe Haven analytic platform is the data to be transferred to?

If a Safe Haven analytic platform is not being used, please explain why.

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Individuals seeking access to linked data in analysis platform

Individuals accessing the data must have completed information governance training and provide evidence of completion

|Named individuals to have access to data |Job Title, Organisation |Email |Name of information governance |

| | | |training, date completed |

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Relevant Expertise

|Please give details of the relevant expertise of the applicant(s) and how it applies to the fields(s) to be researched: |

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PLEASE COMPLETE THIS SECTION ONCE THIS APPLICATION HAS BEEN DISCUSSED WITH THE LRSH TEAM!

Applicant - User Declaration:

I declare that I understand and undertake to abide by the rules for confidentiality, security and access / release of data from LRSH.

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|Researcher/main contact’s name: |

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|Researcher/main contact’s signature: Date: |

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|Safe Haven staff name: |

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|Safe Haven staff signature: Date |

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Please send electronic copy to: ACCORD@nhslothian.scot.nhs.uk

For Office Use:

Post-submission Assessments:

Data assessment

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|Name |Role/affiliation |

|Date | |

Governance assessment

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|Name |Role/affiliation |

|Date | |

Scientific assessment or comment on peer review undertaken

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|Name |Role/affiliation |

|Date | |

Post-review outcome:

Outcome of review by the LRSH Project Review and Advisory Committee

|Approved | |

|Declined | |

|Pending | |

|Notes: |

|Conditions: |

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