Pharmacy Assurance

IMPORTANT: Pharmacy Assurance is going through a phased roll-out and currently is only available to Clinical Trials of Investigational Medicinal Products (CTIMPs). The information below is only relevant to applications going through the combined review service. It is no longer possible for CTIMP applications to be made using this part of IRAS.

**As was already the case in Scotland, it is now expected that NHS sponsors in England and Wales submit their eligible studies through Pharmacy Assurance**

Pharmacy Assurance streamlines the pharmacy capacity and capability assessments carried out by participating NHS/HSC sites by providing a single technical pharmacy review, which is accepted by all participating NHS/HSC sites. This replaces the need to complete separate technical reviews at each participating NHS/HSC organisation. The single review therefore speeds up the site set-up process, enabling studies to commence research activities much quicker.

Pharmacy Assurance uses a standardised technical pharmacy review form and all pharmacy reviewers must have undergone Pharmacy Assurance training before they can conduct Pharmacy Assurance reviews. This ensures consistency in the process across different Trusts and Health Boards. The HRA holds a list of registered Pharmacy Assurance reviewers who can conduct the technical reviews for Pharmacy Assurance. You can download the latest list of registered reviewers from the HRA website.

Pharmacy Assurance has also introduced a standardised review fee per reviewer. This review fee may be applicable to your study. More information about this standardised fee can be found in the Payment Framework Guidance. Please note that some studies may need to be reviewed by more than one registered reviewer depending on the clinical specialisms involved in the trial, such as those involving radiopharmacy.

For further information about the benefits of Pharmacy Assurance please refer to the HRA website.

Pharmacy Assurance is UK-wide but the process varies depending on the location of the lead nation for the study. For details on how to apply for Pharmacy Assurance please select one of the following options:

• How to Apply - lead nation is England or Wales
• How to Apply - lead nation is Northern Ireland
• How to Apply - lead nation is Scotland

This page also provides guidance on:

• Contents of the application pack
• Tips for a successful application
• What to do after Pharmacy Assurance
• How to provide feedback on the process

Lead nation is England or Wales

Eligibility

Where the lead nation is England or Wales, Pharmacy Assurance is available for Phase I - III clinical trials involving investigational medicinal product(s) (CTIMPs) which are taking place in multiple secondary care sites in the NHS/HSC.

Review Routes

Where the lead nation is England or Wales, there are two Pharmacy Assurance review routes to choose from; HRA-managed or Self-managed. The table below outlines the key differences between these two review routes.

	HRA-managed	Self-managed
Overview	The entire process is managed by the HRA on behalf of the applicant. The HRA will liaise directly with both the applicant and with the reviewer. Any queries raised by the reviewer will be cascaded to the applicant by the HRA.	The applicant will manage the review process themselves. The applicant will liaise directly with both the reviewer and the HRA.
Sponsor eligibility	N/A	The study must be sponsored by the NHS, either as the main sponsor or as a co-sponsor.
Reviewer requirements	The HRA will select an appropriate reviewer from the list of registered reviewers. or The applicant can choose up to three trusts/health boards and the HRA will select a reviewer from these where possible. There may be instances where this request cannot be accommodated. In such instances, an alternative reviewer will be selected.	The applicant selects the reviewer themselves. The reviewer must be: on the HRA list of registered reviewers employed by the study sponsor (or co-sponsor) Trust or Health Board involved in the development of the study documents and set up of the study (in particular the sourcing, packaging, and labelling of any investigational medicinal products (IMPs)).
Fee requirements	The standard review fee is applicable per reviewer. Further information is available in the Payments Framework Guidance.	Any review fee charged is at the discretion of the organisation employing the reviewer(s). Further information is available in the Payments Framework Guidance.
When to apply	Pharmacy Assurance is a pre-submission review. You can apply for Pharmacy Assurance at any time point up to and including the date on which you e-submit your IRAS Form for HRA and HCRW Approval, however, where possible we recommend that studies are submitted as early as possible before e-submission for HRA and HCRW Approval
Confirmation of Pharmacy Assurance	The outcome of Pharmacy Assurance will be confirmed by the HRA via email, regardless of which review route is taken. The email confirmation provided by the HRA should be used as proof of Pharmacy Assurance.

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How to apply via HRA-managed route

For HRA-managed studies, the HRA works with the selected reviewer(s) to complete Pharmacy Assurance for your study. The sequence of events is as follows:

1. You (the applicant) should send the application pack and, if applicable, the HRA/Centrally-Managed Reviewer Request Form to pharmacy.assurance@hra.nhs.uk to initiate Pharmacy Assurance.
2. The HRA will check to ensure that all the appropriate documents have been submitted. You will receive an email from the HRA confirming when you have met the submission requirements.
3. The HRA will assign appropriate HRA-registered pharmacy reviewer(s) to complete the technical review. Note:
1. If an HRA/Centrally-Managed Reviewer Request Form was submitted, the HRA will assign requested reviewer(s) wherever possible. Where the requested reviewer(s) is/are not available the HRA will contact you. You can then choose to:
   1. wait for the requested reviewer(s) to become available and delay Pharmacy Assurance; or
   2. request the HRA choose the first available, appropriate reviewer(s).
2. If you have not requested specific reviewer(s) the HRA will select the first available, appropriate reviewer(s).
3. The HRA will share your contact details with the reviewer(s) so that payment arrangements can be made.
4. Where queries arise during the review, the HRA will liaise with you on behalf of the pharmacy reviewer(s) to resolve the query(ies).
5. The reviewer(s) send the completed review form to the HRA.
6. The HRA will send the completed review to you and confirm Pharmacy Assurance. The HRA aims to send this email within 30 calendar days of the initial application for Pharmacy Assurance (excluding any time taken to resolve queries during review).
7. You send the completed review and confirmation of the Pharmacy Assurance email to participating NHS sites. If the review and confirmation email are available before you send out the Local Information Pack to participating NHS sites in England and Wales, you can include them as part of the Local Information Pack. If you have participating NHS sites in Scotland the NHS Research Scotland Permissions Coordinating Centre (NRSPCC) will share this with R&D teams at participating sites. If you have HSC sites in Northern Ireland the Research Gateway will share this with participating HSC sites on your behalf.

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How to apply via self-managed route

For self-managed studies you will need to register the trial as self-managed with the HRA and then liaise with the selected reviewer(s) to complete Pharmacy Assurance for your trial. You should therefore identify the reviewer(s) who will complete the review before you make a submission. The sequence of events is as follows:

1. You (the applicant) should send the Self-Managed Registration Form and relevant information in the covering email from the application pack to pharmacy.assurance@hra.nhs.uk to initiate Pharmacy Assurance.
2. Within 7 calendar days of you submitting all the required documents to the HRA, they will:
   1. Ensure you plan to use HRA-registered reviewers with appropriate specialisms to review the study; and
   2. Email you to confirm that the study has been registered for a self-managed review. They will also provide you with a copy of the technical pharmacy review form for the reviewer(s) to complete.
3. You then request the review from the pharmacy reviewer(s) by forwarding the email from the HRA and the full Pharmacy Assurance application pack.
4. You and the pharmacy reviewer(s) liaise with one another to complete the review. Note: there are no timelines set by the HRA for this part of the process.
5. The reviewer(s) send the completed pharmacy review to you.
6. You send the completed pharmacy review to the HRA (pharmacy.assurance@hra.nhs.uk).
7. The HRA will issue confirmation of Pharmacy Assurance via email. You send the completed review and confirmation of the Pharmacy Assurance email to participating NHS sites. If the review and confirmation email are available before you send out the Local Information Pack to participating NHS sites in England and Wales, you can include them as part of the Local Information Pack. If you have participating NHS sites in Scotland the NHS Research Scotland Permissions Coordinating Centre (NRSPCC) will share this with R&D teams at participating sites. If you have HSC sites in Northern Ireland the Research Gateway will share this with participating HSC sites on your behalf.

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Lead nation is Northern Ireland

**It is now expected that NHS/HSC sponsors in Northern Ireland submit their eligible studies through Pharmacy Assurance**. All other non-NHS/non-HSC sponsors are also strongly encouraged to submit for Pharmacy Assurance.

Eligibility

Where the lead nation is Northern Ireland, Pharmacy Assurance is available for Phase I-III clinical trials involving investigational medicinal product(s) (CTIMPs) which are taking place in multiple secondary care sites in the NHS/HSC. 

Review Routes

Where the lead nation is Northern Ireland, there are two Pharmacy Assurance review routes to choose from; Centrally-managed or Self-managed. The table below outlines the key differences between these two review routes.

	Centrally-managed	Self-managed
Overview	The process is managed by the HSC R&D Application Gateway on behalf of the applicant. The Research Gateway will manage the application process, selection of reviewer and confirm completion of review. The reviewer and applicant will liaise directly to address queries raised during the review.	The applicant will manage the review process themselves, including the selection of reviewers. The applicant will liaise directly with both the reviewer and the Research Gateway.
Sponsor eligibility	N/A	The study must be sponsored by the HSC Trust, either as the main sponsor or as a co-sponsor.
Reviewer requirements	The Research Gateway will select an appropriate reviewer from the list of registered reviewers. or The applicant can choose up to three trusts and the Research Gateway will select a reviewer from these where possible. There may be instances where this request cannot be accommodated. In such instances, an alternative reviewer will be selected.	The applicant selects the reviewer themselves. The reviewer must be: on the HRA list of registered reviewers employed by the study sponsor (or co-sponsor) Trust involved in the development of the study documents and set up of the study (in particular the sourcing, packaging, and labelling of any investigational medicinal products (IMPs)).
Fee requirements	The standard review fee is applicable per reviewer. Further information is available in the Payments Framework Guidance.	Any review fee charged is at the discretion of the organisation employing the reviewer(s). Further information is available in the Payments Framework Guidance.
When to apply	Pharmacy Assurance is a pre-submission review. You can apply for Pharmacy Assurance at any time point up to and including the date on which you e-submit your IRAS Form for governance review, however, where possible we recommend that studies are submitted as early as possible before e-submission for governance review.
Confirmation of Pharmacy Assurance	The outcome of Pharmacy Assurance will be confirmed by the Research Gateway via email, regardless of which review route is taken. The email confirmation provided by the HSC should be used as proof of Pharmacy Assurance.

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How to apply via Centrally-managed route

For Centrally-managed studies, the Research Gateway works with the selected reviewer(s) to complete Pharmacy Assurance for your study. The sequence of events is as follows:

1. You (the applicant) should send the application pack and, if applicable, the HRA/Centrally-Managed Reviewer Request Form to pharmacytechnicalassurance@hscni.net to initiate Pharmacy Assurance.
2. The Research Gateway will check to ensure that all the appropriate documents have been submitted. You will receive an email from the Research Gateway confirming when you have met the submission requirements.
3. The Research Gateway will assign appropriate HRA-registered pharmacy reviewer(s) to complete the technical review. Note:
1. If an HRA/Centrally-Managed Reviewer Request Form was submitted, the Research Gateway will assign requested reviewer(s) wherever possible. Where the requested reviewer(s) is/are not available the Research Gateway will contact you. You can then choose to:
   1. wait for the requested reviewer(s) to become available and delay Pharmacy Assurance; or
   2. request the Research Gateway choose the first available, appropriate reviewer(s).
2. If you have not requested specific reviewer(s) the Research Gateway will select the first available, appropriate reviewer(s).
3. The Research Gateway will share your contact details with the reviewer(s) so that payment arrangements can be made.
4. Where queries arise during the review, the pharmacy reviewer(s) will liaise with you directly to resolve the query(ies).
5. The reviewer(s) send the completed review form to the Research Gateway.
6. The Research Gateway will send the completed review to you and confirm Pharmacy Assurance. The Research Gateway aims to send this email within 30 calendar days of the initial application for Pharmacy Assurance (excluding any time taken to resolve queries during review).
7. The Research Gateway will share the completed review and confirmation of Pharmacy Assurance with participating HSC sites in Northern Ireland, and will inform NHS Research Scotland Permissions Coordinating Centre (NRSPCC) to share with any participating sites in Scotland. You need to send the completed review and confirmation of Pharmacy Assurance email to participating NHS sites in England and Wales. If the review and confirmation email are available before you send out the Local Information Pack to participating NHS sites in England and Wales, you can include them as part of the Local Information Pack.

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How to apply via self-managed route

For self-managed studies you will need to register the trial as self-managed with the Gateway and then liaise with the selected reviewer(s) to complete Pharmacy Assurance for your trial. You should therefore identify the reviewer(s) who will complete the review before you make a submission. The sequence of events is as follows:

1. You (the applicant) should send the Self-Managed Registration Form and relevant information in the covering email from the application pack to pharmacytechnicalassurance@hscni.net to initiate Pharmacy Assurance.
2. Within 7 calendar days of you submitting all the required documents to the Research Gateway, they will:
   1. Ensure you plan to use HRA-registered reviewers with appropriate specialisms to review the study; and
   2. Email you to confirm that the study has been registered for a self-managed review. They will also provide you with a copy of the technical pharmacy review form for the reviewer(s) to complete.
3. You then request the review from the pharmacy reviewer(s) by forwarding the email from the Research Gateway and the full Pharmacy Assurance application pack.
4. You and the pharmacy reviewer(s) liaise with one another to complete the review. Note: there are no timelines yet set by the Research Gateway for this part of the process.
5. The reviewer(s) send the completed pharmacy review to you.
6. You send the completed pharmacy review to the Research Gateway (pharmacytechnicalassurance@hscni.net).
7. The Research Gateway will issue confirmation of Pharmacy Assurance to you via email and will share this with participating HSC sites in Northern Ireland and inform NHS Research Scotland Permissions Coordinating Centre (NRSPCC) to share with any participating sites in Scotland. You send the completed review and confirmation of the Pharmacy Assurance email to participating NHS sites in England and Wales. If the review and confirmation email are available before you send out the Local Information Pack to participating NHS sites in England and Wales, you can include them as part of the Local Information Pack.
   

 

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Lead nation is Scotland

Eligibility

Where the lead nation is Scotland, Pharmacy Assurance is available for all clinical trials involving investigational medicinal product(s) (CTIMPs) taking place in secondary care in NHS Scotland.

Review process

Pharmacy Assurance is processed in accordance with the Scottish Coordinated Pharmacy review process. This will include assigning registered reviewers and liaising with you (the applicant) in case of any queries. Note: you cannot request specific reviewers when using this route. The reviewer is usually the pharmacist setting up the study at the lead site in Scotland.

There is currently no fee for using this route.

When you e-submit your IRAS application for NHS Permission it will automatically be assigned to Pharmacy Assurance / Coordinated Review via the NRS Generic Review process. You do not need to submit any separate application.

How to Apply

The sequence of events is as follows:

1. When you electronically submit the IRAS application and associated documents, NHS Research Scotland Permissions Coordinating Centre (NRSPCC) will check your document set and allocate a study-wide reviewer for your project.
2. The study-wide reviewer will contact their associated pharmacy reviewer to undertake the Coordinated Pharmacy Review / Pharmacy Assurance for your project. You will receive an email if further documents are needed.
3. The pharmacy reviewer sends the completed review to the study-wide reviewer.
4. The study-wide reviewer will issue confirmation of Pharmacy Assurance via email.
5. You send the completed review and confirmation of the Pharmacy Assurance to participating NHS/HSC sites in other nations. If your study is taking place in England and/or Wales and the review and confirmation email are available before you send out the Local Information Pack to participating NHS sites in these nations, you can include them as part of the Local Information Pack. If you have participating HSC sites in Northern Ireland, NRSPCC will send the completed review to the Research Gateway team, who will share the review with the HSC sites.

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Application Pack

Protocol

Investigator's Brochure(s)

Summary of Product Characteristics (SmPC)

Investigational Medicinal Product (IMP) labels as sent to the MHRA

Where the lead nation is England, Northern Ireland or Wales: covering email (see below)

Pharmacy Manual. You are strongly advised to provide the pharmacy manual wherever possible as it will reduce the likelihood of queries during the review. If the pharmacy manual is not provided, Pharmacy Assurance may proceed but it is advised that selected information from the pharmacy manual should be included in a covering email instead. See ‘Tips for a successful application’ for further information.  

Material safety data sheet(s). Please note that Pharmacy Assurance may proceed without this document, however, you are strongly advised to provide it wherever possible as it will help the reviewer(s) and reduce the likelihood of queries.

Pharmacy Assurance - Covering email where the lead nation is England, Northern Ireland or Wales should include:

1. IRAS ID
   
2. Confirmation of the lead nation
3. Confirmation of which UK nations are planned to participate in the trial
4. Name of the lead NHS/HSC R&D office
5. Full study title
6. Short study title
7. The following information:
   

Question	Location in the new part of IRAS for studies applying through combined review
Phase of CTIMP	Medicines Information question E7
Total UK sample size	Medicines Information question F4-1
Sponsor organisation	Medicines Information question B1
Number of UK sites in the study	Medicines Information questions E8-3 (single site studies) or E8-4-1 (multi-site studies)
Confirmation of whether the study will involve primary care	This is not a question in the new part of IRAS. You should still confirm this within your covering email
Confirmation of whether any investigational medicinal products (IMPs) are advanced therapy medicinal products (ATMPs) or radiopharmaceuticals	Medicines Information questions D3-11-3 or D3-11-5

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Tips for a successful application

Errors or omissions in the application for Pharmacy Assurance may delay the progress of the review and in some instances may lead to the application being rejected. Below are some tips to avoid some of the common errors and to speed up the review process:

For studies with a non-commercial sponsor, involve an NHS/HSC trial pharmacist in the design of your study at the earliest possible stage to ensure that the trial can be conducted in the NHS/HSC.

Make sure that all your documents have been submitted in accordance with instructions in the section above.

We strongly recommend that a pharmacy manual is submitted with the application pack. This will reduce the number of queries during the review process. Where the pharmacy manual cannot be provided, we recommend that a covering email or letter is provided to include any information from the pharmacy manual that is not included in the pharmacy technical review form. You can view an exemplar pharmacy technical review form to help with this.

If your trial has multiple parts but the UK will only be participating in certain parts of it, please ensure that this is clear in your submission so that reviewers do not look at information which is not applicable to the UK. It is a good idea to highlight this in a covering email.

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After Pharmacy Assurance

It is important to note that any amendments to your trial will not be reviewed through Pharmacy Assurance. If the information contained within the technical pharmacy review form becomes outdated due to a change in the protocol or other supporting documents, please visit the guidance in the Maintaining your Approvals section of IRAS Help.

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Providing Feedback

We strive to ensure that the Pharmacy Assurance process is effective and efficient, and we welcome all feedback on the Pharmacy Assurance process, including from sites who have received a study, which has been through Pharmacy Assurance. Please email the Technical Assurance team via pharmacy.assurance@hra.nhs.uk to submit any feedback or comments on the service.


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Page last updated: 28 February 2022