1

“Flash-Mob” Audit of Intravenous

Immunoglobulin Use in ITP

Protocol v1.6

3rd October 2018

Key Dates:

Initial Protocol release: 31st August 2018

Local Audit Registration Period: 1st Sept – 1st Dec 2018

Data Collection Period 1st Oct – 1st Dec 2018

2

Table of Contents

Title Page

Protocol Amendments 2

Management Committee 3

Key Contact 3

Acknowledgements 3

Project Timeline 4

About HaemSTAR 4

Introduction 5

Aim and Objectives 5

Audit Standards 7

Methods 7-13

References 13

Appendix 1: eCRF 14-27

Appendix 2: Proof that ethical review is not required 28

Appendix 3: Deadlines 29

Protocol Amendments

v1.6 03/10/2018

Updated data completeness required to gain co-authorship to reflect the minimum data set required

for completion of the audit part of this project. Added Protocol Amendment section. Point 4 of the

flowchart on page 10 has been amended to say that the password protected and encrypted

spreadsheet linking the REDCap identifiers to the patients’ hospital number should only be deleted

after data cleaning (at which point the hospital teams will be informed) rather than at the final data

submission point of the audit. Added explanation to the financial arrangements section to state that

REDCap is provided by BiSTC and hosted by the University of Birmingham. Updated CRFs to give

option to enter dose of IVIg in g and body weight in kg or simply to write the dose in g/kg as well as

the option to merely state the number of years ago previous treatments had ceased if this was > 2

years before the current IVIg treatment episode. Added secondary outcome measure to reflect

explorations of correlations between IVIg response and other data collected for use in future

hypothesis generation.

3

Management Committee

Name Role

Gemma Scott HaemSTAR Lead for Wales, Speciality Registrar in Clinical Haematology, University Hospital of Wales, Cardiff and Vale NHS Trust.

Amelia Fisher HaemSTAR Lead for Yorkshire, NIHR Academic Clinical Fellow, Speciality Registrar in Haematology, Leeds Teaching Hospitals NHS Trust, Leeds, Yorkshire

Pip Nicolson National HaemSTAR co-chair, BHF Clinical Research Training Fellow, Institute of Cardiovascular Sciences, University of Birmingham; Specialty Registrar in Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust

Quentin Hill Consultant Haematologist, Leeds Teaching Hospitals NHS Trust Gillian Lowe Consultant Haematologist, University Hospitals Birmingham NHS Foundation

Trust; Co-Clinical Specialty Research Lead, West Midlands Clinical Research Network

Key Contact

Pip Nicolson Office 129, IBR 1st Floor, Institute of Cardiovascular Sciences,

University of Birmingham, B15 2TT, 0121 415 8678, p.nicolson@bham.ac.uk

Acknowledgements

Name Institution

Thomas Pinkney West Midlands NIHR Local Clinical Research Network

Laura Magill Birmingham Surgical Trials Consortium (BiSTC) Rita Perry Birmingham Surgical Trials Consortium (BiSTC)

This project has been made possible by the Katie Bolam Award (2018) from the Scientific and

Academic Coagulation Consortium and support from the NIHR West Midlands LCRN

4

Project Timeline

Dates Project Target March – April 2018

Obtain data manager and trials unit support to assist with REDCap tool set up and data collection. Recruit Statistician to help with design of data collection fields.

May – August 2018 August – September 2018 October - December 2018 December 2018 – February 2019 April 2019

Pilot the protocol in Cardiff University Hospitals, Leeds Teaching Hospitals and University Hospitals Birmingham NHS Trusts. Promotion of the audit and recruiting centre leads via the HaemSTAR network and Consultant clinical experts in ITP. 2 months to run the audit. Data evaluation and presentation. Dissemination of results to involved parties and stakeholders Submission of final analysis for publication

About HaemSTAR

HaemSTAR is a UK-wide network of clinical haematology registrars that is supported by the National Institute of Health Research (NIHR) non-malignant clinical research network (CRN). It has a national steering group who decide on strategy and prioritise the network activity. It has lead members in each NIHR Local CRN who coordinate the local research activity and involvement of other haematology registrars as is needed. The overarching aim of HaemSTAR is to promote clinical research in non-malignant haematology. It does this in four ways: by increasing the number of participants to non-malignant haematology trials nationally; by enabling effective transition of worthy local audits to the national scale; by developing and rolling out its own national studies which align with NIHR research priorities; and by exposing clinical haematology registrars to NHS Trust Research and Development (R&D) departments and the NIHR in order to develop Principle Investigator (PI) skills which are not currently part of the haematology registrar training curriculum. For more information visit www.HaemSTAR.org

For this “Flash-Mob Audit” HeamSTAR will provide support for gaining audit department approval, provide the eCRF to and coordinate the activity of haematology registrars engaged in data collection such that any and all hospitals with haematology registrar presence are eligible and encouraged to take part in this audit.

Authorship: HaemSTAR authorship policy provides PubMed-citable co-authorship to all collaborators involved in a study. An example of this can be seen here: https://www.ncbi.nlm.nih.gov/pubmed/23842836 . Collaborators will be granted co-authorship if their site fills out ≥ 5 eCRF’s with ≥40% data inclusion.

5

Introduction

Background

Immune thrombocytopenia (ITP) is an autoimmune condition causing increased destruction, and often

the inadequate production of platelets. Together this results in low platelet counts and the risk of

bleeding. In adults the disease course is more commonly chronic requiring individualised treatment to

maintain platelet counts at a safe level.

The most common first line therapy in adult patients requiring treatment is corticosteroids with or

without intravenous immunoglobulin (IVIg). These agents are often required later in the disease

course for relapse or to raise the platelet count prior to a surgical procedure. The initial response rate

for IVIg is 80% (Godeau). The response is typically rapid with some patients responding in 24 hours,

although typically 2-4 days (Provan). When used alone the response is relatively short averaging

around 2-4 weeks. There are side effects associated with the use of IVIg, including headache, renal

failure and risk of thrombosis (Debes). IVIg is made from human plasma so there is a theoretical risk

of infectious disease transmission. The cost of IVIg is significant averaging £400 for 10g.(BNF)

The most common dosing regimens for IVIg are either 1g/kg/day for 1-2 days or 0.4g/kg/day for 5

days. There is data to suggest an increased likelihood of response with 1g/kg/day for 1-2 days than

0.4g/kg/day for 5 days (Bussel).

Guidelines

Recent guidance from NHS England recommends 1g/kg for 1 day with a second dose of 1g/kg at 7

days only if there is a failure to achieve a haemostatically adequate platelet count. This advice is

based on guidelines produced by the American Society of Haematology (ASH) in 2011 (Neunert).

However, other guidelines are more flexible suggesting 1g/kg for 1-2 days (Provan). It is important to

note that recommendations made on dosing are based on small data sets. Using the optimal dosing

regimen is important for maximum efficacy, the avoidance of side effects and prudent health care.

Aim

This project aims to obtain a snapshot of the IVIg prescribing practises for treatment of ITP in the UK.

In doing so it will also develop a generalisable methodology for performing mass participation audits

in non-malignant haematology.

Objectives

The objectives of this project are: 1) to evaluate the doses and duration of IVIg against the standard

1g/kg dose stated in the ASH Guidelines; 2) to examine the indications for which IVIg is used in the

UK and whether this adheres to the indications set out in the ASH guidelines (see Audit Standards);

3) to examine response rates and time to response for IVIg at this 1g/kg dose; 4) to gain insight into

factors influencing response such as concomitant and previous treatment. It is hoped that this will

enable hypothesis generation for future prospective studies.

Data will be obtained from a retrospective multi-centre audit of use of IVIg for patients with ITP in the

UK over last 5 years. Suitable centres will be identified by clinical experts in the field of ITP and

investigators recruited via HaemSTAR, a collaboration of Haematology registrars with a

representative in each region of the UK. Patients will be identified locally via the department

responsible for providing the IVIg supply; this is usually pharmacy or blood bank.

The REDCap data entry platform (Harris) will be used to host online audit data collection forms,

enabling mutli-centre data entry that is secure and consistent.

The audit protocol will focus around key the recommendations of the Neunert et al 2011 paper for IVIg

dosing and explore patient-specific variables that could highlight trends in patients who have been

given different dosing regimens. The data collected will include patient sex and weight; type of ITP i.e.

primary or secondary, first or subsequent use of, and indication for, IVIg; concomitant and previously

6

trialed therapies; dosing, duration of IVIg; and the patient’s platelet response to IVIg according to the

standardised criteria outlined in Neunert et al 2011 and reproduced in Table 1.

The large, real world data set data generated from this audit will be large and not before achieved in

the ITP setting. It will form an accurate and up to date demonstration of the current IVIg use in the UK.

It will identify the number of patients receiving an IVIg dosing regimen that is not consistent with

current guidance. Data will be analysed using statistical methods such as a multivariable logistic

regression model to identify the effects that patient factors and the dose received have on the

response to treatment. By integrating these results, we expect the data to lead to a series of

recommendations that can target the areas for improvement in IVIg prescription as well as identify

areas for future randomised prospective research. It may identify areas where lower amounts of IVIg

can be used and therefore we hope these recommendations can be associated with a projected cost

saving.

Complete response (CR) A platelet count ≥ 100 x 109/L measured on 2 occasions > 7 days apart and the absence of bleeding.

Response (R) A platelet count ≥ 30 x 109/L and a greater than 2-fold increase in platelet count from baseline measured on 2 occasions > 7 days apart and the absence of bleeding.

No response (NR) A platelet count < 30 x 109/L or a less than 2-fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on 2 occasions more than a day apart.

Loss of complete response A platelet count < 100 x 109/L measured on 2 occasions more than a day apart and/or the presence of bleeding.

Loss of response A platelet count < 30 x 109/L or a less than 2-fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on 2 occasions more than a day apart.

Table 1: Definitions of response to treatment by ITP (reproduced from Neunert et al. 2011)

7

Audit Standards

ASH Guidelines, Neunert et al 2011.

ITP In the Adult:

4.2.A:

• Treatment be administered for newly diagnosed patients with a platelet count <30 x 109/L

4.3.A:

• IVIg be used with corticosteroids when a more rapid increase in platelet count is required.

• Either IVIg or anti-D (in appropriate patients) be used as a first-line treatment if corticosteroids

are contraindicated.

• If IVIg is used, the dose should initially be 1 g/kg as a one-time dose. This dosage may be

repeated if necessary.

5.1.A:

• Against further treatment in asymptomatic patients after splenectomy who have platelet

counts > 30 x 109/L.

Methods

Summary

Pan-UK retrospective audit of all patients receiving IVIg for treatment of ITP over a 5 year period.

Collaborative Teams

Collection period: 1/10/18 – 1/12/18. All eligible patients who received IVIg between 1/6/13 and

31/5/18 should have their eCRFs filled in during this period. Each centre should have a centre-team to

collect data during this period.

All data collectors, local leads, supervising consultants, regional leads and management committee

members will be eligible for PubMed-citable collaborative co-authorship.

Management Committee: a core group of haematology trainees and consultants responsible for

protocol design, data handling, analysis and drafting of the paper. The Management Committee are

responsible for use of data resulting from the project.

Regional leads: a network of collaborators across the UK responsible for co-coordinating teams at

local hospitals. The regional leads act as a link between local teams and the management committee.

They are the first point of contact for local collaborators. Each regional lead should aim to recruit 4-5

centre-teams. To qualify for authorship, regional leads must recruit at least three centre-teams unless

otherwise agreed in advance with the management committee. In exceptional circumstances where a

region has very few hospitals with haematology trainee presence; those regions with fewer than three

centre-teams will still qualify for authorship.

Centre-teams: each local centre requires one supervising consultant and a centre-team consisting of

haematology and medical trainees. Each centre-team should be made up of up to 5 collaborators.

8

Collaborators are responsible for identifying eligible patients and collecting data. One collaborator

should be selected to act as the ‘local lead’.

A maximum of 5 collaborators per centre-team will be listed as ‘PubMed’ citable authors unless

otherwise agreed in advance by the management committee. In exceptional circumstances where

local teams anticipate a very high volume of patients being eligible for inclusion, they may contact the

management committee for permission to add an additional collaborator to their team.

Local leads: each centre will require 1 collaborator to act as the “local lead”. The lead is responsible

for: 1) ensuring the audit is registered locally; 2) contacting the supervising consultant; 3) sending the

management committee the contact details of the collaborators from their centre; 4) making sure all

deadlines are met (Appendix 3); 5) ensuring all data is submitted from their centre; and 6) helping with

data collection. These individuals will be listed in the final authorship as local leads, in recognition of

their contribution.

Supervising Consultant: one consultant per centre is eligible for collaborative PubMed citable co-

authorship if they meet the following criteria: 1) Supports local audit registration; 2) Circulates

information about the audit and the audit protocol to consultant colleagues; 3) Facilitates presentation

of local audit results at a departmental audit meeting; 4) Completes workplace-based assessments for

trainees (ePortfolio), if asked. Consultants should ensure collaborators act in accordance within

governance guidelines and should facilitate implementation of post-audit interventions, if required.

Dissemination and Publication of Results

We will audit the 2011 American Society of Hematology ITP treatment guidelines. The results of the

audit will be disseminated through:

• Local presentations – teams at all centres will need to provide the contact details of the local

consultant supervisor and the local audit officer.

• Publication in a major haematological journal.

• Presentation at regional and national meetings.

Publications and national presentations will not identify individual Trust performance.

Centres

• Any hospital that has a haematology trainee presence may participate.

• All participating centres are required to register the audit according to local regulations.

Confirmation of successful registration will be required prior to issue of REDCap logins.

• Two permanent contacts at each hospital are required (supervising consultant and audit

officer) to return hospital specific results.

9

▲

Providing feedback on the audit’s findings to your department’s clinicians is an essential step in the

audit loop. Presenting local results will help collaborators develop analytical and presentation skills

and will boost their CVs. ▲

Inclusion Criteria

• Patients aged 18 or above who have a confirmed diagnosis of ITP.

• Patients have received their first IVIg treatment on or after 1st June 2013 but before 31st May

2018.

Exclusion Criteria

• If unable to confirm that first documented episode was the first actual episode of IVIg use then

exclude patient.

• If platelet count assessments do not meet the following criteria then exclude that particular

IVIg treatment episode:

o Platelet count at baseline

o Platelet count 1 ≤ 14 days from the date of the 1st day of IVIg infusion

o Any subsequent platelet count ≥ 7 days after platelet count 1

It is essential that the first treatment of IVIg is included in the audit as response rates and durations

are likely to diminish with each subsequent treatment course. If the first IVIg treatment episode

identified cannot be confirmed as the first episode that the patient received, then the patient is

ineligible to be included in the audit.

Strategies to identify patients could include:

1. List of IVIg prescriptions approved by the IVIg Panel / Committee.

2. List of IVIg prescriptions obtained from hospital pharmacy or blood bank cross referenced with list of patients

coded as having immune thrombocytopenia in hospital computer system.

3. Centre-teams have permission to contact the ITP registry for a list of patients prescribed IVIg from their centre.

The ITP registry will provide the patient’s unique study entry code which can be cross-referenced with the site

screening log for the ITP registry.

4. Databases of patients with ITP given IVIg kept at individual centres.

Flowchart for patient identification and data collection

1. Approach IVIg Panel / Committee and request list of the prescriptions they have approved

since 1/6/2013. (DoH guidance states that an IVIg Panel / Committee must have been in

place in all hospitals in England who use IVIg since 1/1/2013. These prescriptions will have

diagnosis and indication written on them).

2. If (1) is unfeasibile then obtain a list of all IVIg prescriptions/administrations between 1/6/2013

and 31/5/2018 from pharmacy or blood bank (policy differs in different hospitals as to where

these records are stored). This will probably be in electronic format but with no information as

regards diagnosis or indication.

10

a. Password protect the file and ensure it is stored on encrypted device / hard drive.

b. Order data first by date and then by patient identifier.

c. Utilise the following strategies to identify ITP patients from this list:

i. Look at location of IVIg infusion. Those on inpatient neurology wards, for

instance, are unlikely to have a diagnosis of ITP. Those on a haematology

day unit are likely to include those patients with ITP. (though there will be

patients who receive IVIg infusions for ITP in other locations).

ii. Look at dose of IVIg. Those that are in the range of 1g/kg are likely to be

patients with ITP (though some ITP patients will be given lower doses than

this).

iii. For each individual patient, select the first IVIg episode and consult electronic

clinic letters / clinical coding documents to see if they have a diagnosis of ITP

and, if so, check to see if this was the first IVIg episode that that patient

received (If it was not the first IVIg episode then exclude this patient).

iv. Cross reference the list with individual databases of ITP patients that may be

kept in individual trusts.

3. If (1) and then (2) have been unsuccessful then contact the ITP registry

(abbas.zaidi@bartshealth.nhs.uk) and ask for a list of the unique study identifiers of patients

who have been registered with the ITP registry at your centre and have received IVIg along

with all the dates of infusions from 1/6/13 onwards.

a. Once you receive this list, If you are on the delegation log for the ITP registry then

use the IVIg registry study file to identify patients from their unique identifiers.

b. If you are not on the delegation log for the ITP registry, ask a friendly research nurse /

haematology trainee who is on the delegation log / PI for the study to do this for you.

4. If, by using (1), (2), or (3), you have identified a patient with ITP whose first IVIg treatment

episode was at your hospital and between the 1/6/13 and 31/5/18 then proceed to fill in eCRF

for this patient and add information detailing the REDCap generated identifier to the

encrypted and password protected spreadsheet (this spreadsheet is purely to be kept locally

to ensure that data entry is not duplicated, it should not be sent to the central study team and

should be deleted after data cleaning. You will be instructed when this is by email contact

from the central team).

Outcome Measures

Primary outcome measure

• The primary outcome measure is the proportion of IVIg treatment episodes that are dosed

according to the ASH guidelines. (The audit standard is provided by the American Society of

Haematology (Neunert et al, 2011) which states that “the dose should initially be 1 g/kg as a

one-time dose. This dosage may be repeated if necessary.”)

Secondary outcome measures

• The indication for IVIg treatment (IVIg should be reserved for patients who are bleeding or

who require a higher platelet count to facilitate surgery or delivery of pregnancy).

• The complete response rate and the response rate as well as response duration. (This has

previously been reported to be 60-80% partial platelet response rate for a duration of 2-4

weeks (Godeau, Bussel) but no response rates have been measured for the 1 g/kg one-time

dose.)

• To explore if there is a correlation between previous IVIg treatment, previous or concomitant

treatment with other medications, sex, pregnancy and type of ITP on IVIg response to

generate hypotheses for future studies.

11

Data Collation

Anonymised data will be collected and stored online through a secure server running the Research

Electronic Data Capture (REDCap) web application (https://bistc.redcap.bham.ac.uk/). Login

information for REDCap will be generated for each collaborator upon confirmation of audit

registration. REDCap allows collaborators to enter and store data in a secure system. Collaborators

will be given secure REDCap project server login details, allowing secure data storage on the

REDCap system. No patient identifiable information will be collected. Collaborators may wish to first

record data on a paper version of the data collection pro-forma. Paper copies of any data should be

destroyed as confidential waste within the centre once uploaded to REDCap. An example of the

REDCap eCRF is included in Appendix 1.

Follow Up

As this is a retrospective audit, no follow up of patients is required.

Local Project Registration

It is the responsibility of the local centre-team at each site to identify a local supervising consultant

haematologist and to ensure that the audit is registered appropriately.

Confirmation that ethical review is not required for the audit is available in Appendix 2. Examples of

audit registration forms answers can be found on the HaemSTAR website. When registering this as a

clinical audit you should emphasise that:

• The audit will measure current practice against established standards.

• It is a national audit.

REDCap accounts will not be issued until evidence is sent to the management committee showing the

successful registration with the audit department, including the email address of the local audit officer.

▲

You must have confirmation of successful audit registration prior to commencing data collection. If you

encounter difficulties with registering the study, seek advice from your supervising consultant, your

local lead, or the HaemSTAR management committee. ▲

Data Governance

Data will be recorded contemporaneously and collated on a dedicated, secure, web-based platform.

This will be password protected, and no personal data that can identify the individual patient (name,

date of birth, address…etc) will be recorded. Registered local investigators will have individual

password-protected access to all of their unit’s data entered during the audit. During this 2 month

period, units will use an identification number assigned by the secure platform to identify each

individual patient and allow re-accessing of an individual’s records to allow it to be amended and

updated, whilst also preventing duplication of patient entry to the audit. No linkable patient identifier

will be held on the database. As such it will not be possible for the central investigating team to

identify the patients. During the running of the audit, only local data will be visible to investigator and

other sites’ data will be compartmentalised elsewhere.

12

We are utilising the Research Electronic Data Capture (REDCap) system to design, host and support

the online tool (www.project-redcap.org). This system has been previously used extensively to

electronically capture and store sensitive health data in a secure and encrypted format for similar

projects within the NHS in the UK.

Data will be stored securely and on encrypted and certified servers for a minimum of five years at the

University of Birmingham. The data may be used for future research although it should be noted that

the anonymised nature of the database means individual patients will not be reverse-identifiable in the

future.

The only local data to be stored will be password protected spreadsheets linking IVIg prescriptions,

unique hospital identifiers and system assigned identifiers. This will be held in local centres on

encrypted servers. This information will not be shared with the central management committee and

will be deleted at the point of data lock.

Quality Assurance

Protocol

This protocol was produced with guidance from an expert advisory group comprising members of the

West Midlands NIHR LCRN and the Birmingham Surgical Trials Consortium (BiSTC). Audit standards

and audit methodology were developed in order to adhere to guidelines produced by the

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative (von Elm

et al 2007). The protocol was then refined further following extensive discussion at HaemSTAR

meetings.

Pilot

Participating centres may pilot patient identification and the initial stages of data collection, including

use of REDCap, for one day in the week leading up to their data collection start date. Any problems

identified should be addressed by discussion with the management committee. This data will not be

included in the final data analysis.

Data completeness

Following data collection, only data sets with >40% data completeness will be accepted for pooled

national analysis. Centres with >60% missing data points will be excluded and collaborators from

those centres withdrawn from the published list of citable collaborators.

Data Analysis

The statistical methodology for this national audit have been discussed with expert statisticians. The

data will be analysed using descriptive methods and multi-logistic regression models.

The sample size is projected to include over 50 centres within the UK. We estimate that each hospital

will treat 1 ITP patient per month with IVIg. Over the 5 year time frame for retrospective data collection

this equates to 60 episodes of IVIg use for each centre. Allowing for most patients receiving 5

treatments of IVIg during the course of their disease this indicates there will be about 12 recruited

patients per centre. This extrapolates to 400-600 patients being included. We will however, be happy

to exceed this number in terms of both number of centres and also number of patients.

13

Financial arrangements

This study is supported by the Academic and Scientific Coagulation Consortium as well as the NIHR

West Midlands LCRN. Support in the form of finance and expertise from these organisations have

been used to design and host the secure online data collection forms. The REDCap system used is

provided by the BiSTC and hosted by the University of Birmingham. No registration fee is payable by

units to join the project or to enter data online. Similarly, no financial reimbursement will be made to

units or investigators for their involvement in the project.

References

Bussel J. Intravenous immune serum globulin in immune thrombocytopenia: clinical results and

biochemical evaluation. Vox Sang. 1985;49(suppl 1):44-50.

Debes et al. Pharm Drug Safety 2007;16:1038–1047

Godeau B et al. “Intravenous immunoglobulin or high-dose methylprednisolone, with or without

oral prednisone, for adults with untreated severe autoimmune thrombocytopenic purpura: a

randomised, multicentre trial.” Lancet. 2002 Jan 5;359(9300

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG, Research electronic data

capture (REDCap) – A metadata-driven methodology and workflow process for providing

translational research informatics support, Journal of Biomedical Informatics, April 2009, 42(2),

pp. 377-81

Neunert C, Lim W, Crowther M et al. The American Society of Hematology 2011 evidence-based

practice guideline for immune thrombocytopenia. Blood 2011;117:4190-4207

Provan D, Stasi R, Newland AC, et al. International consensus report on the investigation and

management of primary immune thrombocytopenia. Blood 2010;115(2):168-186.

von Elm, E, Altman, DG, Egger, M, et al. The Strengthening the Reporting of Observational

Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies.

Ann Int Med 2007;147(8) 573-577.

14

Appendix 1: CRF

15

16

17

18

19

20

21

22

23

24

25

26

27

28

Appendix 2: Confirmation that Ethical Review is not required

09/06 /2018, 21 05Result - NOT Research

Page 1 of 2ht tp://www.hra- decisiontools.org.uk/research/result7.html

Go straight to content.

Is my study research?

To print your result with title and IRAS Project ID please enter

your details below:

Title of your research:

“Flash- Mob” Audit of Intravenous Immunoglobulin Use in ITP

IRAS Project ID (if available):

You selected:

'No' - Are the participants in your study randomised todifferent groups?'No' - Does your study protocol demand changingtreatment/ patient care from accepted standards for any ofthe patients involved? 'No' - Are your findings going to be generalisable?

Your study would NOT be considered Research by the NHS.

You may still need other approvals.

Researchers requiring further advice (e.g. those not confident withthe outcome of this tool) should contact their R&D office orsponsor in the first instance, or the HRA to discuss your study. Ifcontacting the HRA for advice, do this by sending an outline of theproject (maximum one page), summarising its purpose,methodology, type of participant and planned location as well as acopy of this results page and a summary of the aspects of thedecision(s) that you need further advice on to the HRA QueriesLine at HRA.Queries@nhs.net.

For more information please visit the Defining Research table.

Follow this link to start again.

Print This Page

NOTE: If using Internet Explorer please use browser print function.

29

Appendix 3: Deadlines

• 1/10/2018: Deadline for completion of local audit registration.

• 1/12/2018: Deadline for completion of data collection and submission of all eCRF’s to

REDCap.