Help - Preparing & submitting applications - Pharmacy Assurance
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Pharmacy Assurance

Pharmacy Assurance



Pharmacy Assurance is a process that 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 single review aims to speed up the site set-up process, enabling studies to commence research activities much quicker. For further information about the benefits of this process please refer to the Health Research Authority (HRA) website.

Currently, Pharmacy Assurance is available for all clinical trials involving investigational medicinal product(s) (CTIMPs) and combined CTIMP and clinical investigation of medical device trials taking place in secondary care in the NHS/HSC.

All studies meeting the above criteria with the lead nation in Scotland will be reviewed through Pharmacy Assurance / Scotland's Coordinated Pharmacy Review Process.

For Northern Ireland, those studies meeting the above criteria will be managed through the HSC permission process.

If the lead nation for the trial is in England or Wales, Pharmacy Assurance is only currently available if the trial is a Phase I - III clinical trial in oncology or a Phase III trial in non-oncology. Other study types will be accepted at a later date.

You can seek Pharmacy Assurance through different routes depending on:
  • Which of the UK nations the lead nation for your clinical trial is located in; and
  • Whether you take the 'self-managed' route or not.
Depending on the lead nation for the study, you may have to pay a fee to go through Pharmacy Assurance. In many cases, Pharmacy Assurance will be completed by a single reviewer, but some studies might need more than one reviewer.

More information about these routes and how to apply for Pharmacy Assurance are provided in the sections below:



Review routes and eligibility

In many cases the Pharmacy Assurance will be completed by a single registered pharmacy reviewer through one of the routes set out below. However, some trials 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.

The ways in which an application may be managed is dependent on the lead nation for the trial. The table below sets out which route(s) may be available to you by location of the lead nation for your study as well as providing more information about the route, any eligibility criteria and fees that apply. The next section of this guidance provides instructions for how to apply using your selected route.



Location of lead NHS/HSC


Information about route, including any eligibility criteria and fees

England


Northern Ireland


Scotland


Wales


'Self managed route'
Yes Yes Yes Yes
When using this route you will be expected to select reviewer(s) from the Registered Reviewer List and manage the review process. You will need to notify the HRA that you are using this route so that the trial can be registered as using the self-managed Pharmacy Assurance route. For more information refer to the flowchart of this review process on the HRA website.

Eligibility criteria:
This route is available when the:
  • Trial has a non-commercial sponsor; and
  • The selected reviewer(s):
    • is/are employed by the same Trust or Health Board as the sponsor (or co-sponsor) for the trial; and
    • has/have been 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)).

When to apply for Pharmacy Assurance:
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 approval(s) to undertake research in the NHS/HSC. Please refer to the next section of the guidance for information on how to apply.

Fees:
The standardised review fee does not apply. Any review fee charged is at the discretion of the organisation employing the reviewer(s). Please refer to the Payments Framework Guidance for further details.



Other routes available


'HRA managed' (Lead nation must be England or Wales)
Yes N/A N/A Yes
HRA will manage the Pharmacy Assurance for the trial. This includes ensuring all the required documents have been submitted, assigning registered reviewer(s), managing the review process and liaising with you when required. Note: when using this route you can request specific reviewer(s) through submission of an 'HRA-Managed Study Reviewing Trust/Health Board Request Form', however you should note that there may be instances where your request cannot be accommodated. In such instances, an alternative reviewer will be selected.

Eligibility criteria:
This route is available to any trial which:
  • has its lead NHS site in England or Wales; and
  • is not using the self-managed route (e.g. does not meet the criteria); and
  • has multiple participating sites; and
  • has the standard fee available for review; and
  • is in the current rollout phase.

When to apply for Pharmacy Assurance:
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. Please refer to the next section of the guidance for information on how to apply.

Fees:
Please be aware that there is a standard review fee applicable when using this route. Further information is available in the Payments Framework Guidance .


Northern Ireland
N/A Yes N/A N/A
Pharmacy review will be processed in accordance with local practices. This will include assigning registered reviewers and liaising with you in the case of any queries. Note: you cannot request specific reviewers when using this route.

Eligibility criteria:
This route is available to any trial which:
  • has its lead HSC site in Northern Ireland; and
  • is not using the self-managed route (e.g. does not meet the criteria).

When to apply:
You can apply for pharmacy review at any time point up to and including the date on which you e-submit your IRAS Form for HSC Permission. Please refer to the next section of the guidance for information on how to apply.

Fees:
The review fee will apply when Pharmacy Assurance is rolled out in Northern Ireland .


Scotland
N/A N/A Yes N/A
Pharmacy Assurance will be processed in accordance with the Scottish Coordinated Pharmacy review process for  studies that meet criteria for all specialities. This will include assigning registered reviewers and liaising with you in case of any queries. Note: you cannot request specific reviewers when using this route. In general the reviewer will be the pharmacist setting up the study at the lead site in Scotland.

Eligibility criteria:
This route is available to any trial which:
  • has its lead site in Scotland; and
  • is not using the self-managed route (e.g. does not meet the criteria).

When to apply for Pharmacy Assurance:
When you e-submit your IRAS Form for NHS Permission it will automatically be assigned to Pharmacy Assurance / Coordinated Review via the generic review process. You do not need to submit any separate application. Please refer to the next section of the guidance for information on how to apply.

Fees:
There is currently no fee for using this route.



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Applying for Pharmacy Assurance

If the lead nation is England or Wales
Pharmacy Assurance is a pre-submission review. We recommend that studies are submitted no later than three weeks before e-submission for HRA and HCRW Approval. Documents submitted should be the final version (with the exception of the IRAS Form) to be submitted to the regulators for review.

If the lead nation is Northern Ireland or Scotland
The study will be processed according to national processes when the e-submission is made to the coordinating function.

All studies
Whichever route is used, the application pack for Pharmacy Assurance consists of:
  • Protocol
  • Investigator's Brochure(s)
  • Summary of Product Characteristics (SmPC)
  • Investigational Medicinal Product (IMP) labels as sent to the MHRA
  • Draft IRAS Form, if available (Pharmacy Assurance review will use the e-submitted final or draft IRAS Form, if present). Please note if this is not present in the submission the study can still proceed, but selected information from the form will need to be provided in a covering email if this has not been completed (see below)
  • Pharmacy Manual. 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.
  • 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.
Submission of the IRAS Form is not a mandatory requirement. However, if you choose not to submit the form, we would require the following in a covering email:
  • IRAS ID
  • Study type selected at question 2 of the IRAS project filter page
  • Confirmation of the lead nation
  • Name of the lead NHS/HSC R&D office
  • Full study title
  • Short study title
  • Phase of CTIMP as per question A8 of the IRAS Form
  • Clinical specialism(s) listed in question A15 of the IRAS Form
  • Sponsor organisation as per question A64 of the IRAS Form
  • Confirmation of whether any investigational medicinal products (IMPs) are advanced therapy medicinal products (ATMPs) or radiopharmaceuticals as per Part B Section 1 question 15-3 of the IRAS Form


The particular Pharmacy Assurance route you are taking dictates how you submit these documents and whether you need to complete any other forms. Please refer to the table below for more information.


Review route


How to apply for Pharmacy Assurance (application method)


What to submit


Where to submit


'Self-managed route'
(information about this route is provided in the previous section)

To register your trial as self-managed you will need to submit:
Email document(s) to HRA (hra.pharmacyassurance@nhs.net)

To initiate the Pharmacy Assurance review with the reviewer you will need to send the application pack set out above together with the registration email you receive from the HRA.

Email to selected Pharmacy Assurance Reviewer(s).





'HRA-managed' (Lead nation must be England or Wales; information about this route is provided in the previous section)

To initiate Pharmacy Assurance review you will need to submit:

Email document(s) to HRA (hra.pharmacyassurance@nhs.net)


Northern Ireland
(information about this route is provided in the previous section)


In the first instance you will need to contact the HSC R&D Application Gateway to request Pharmacy review and seek further information.


Email the HSC R&D Application Gateway (research.gateway@hscni.net).


Scotland
(information about this route is provided in the previous section)


Not applicable - Pharmacy Assurance / Coordinated Review sought through this route is triggered by e-submission of the IRAS Form.


Your application will automatically be processed through Pharmacy Assurance / Coordinated Review upon e-submission of your IRAS Form and associated documents.

You will be contacted if any additional document(s) are needed.



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Tips for a successful application

Errors or omissions in the application for Pharmacy Assurance usually 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 of your documents have been submitted in accordance with instructions in the table above.
  • If you will produce a pharmacy manual for your trial and it is available at the point of submission, it is best practice to include a copy for review. We recommend this is done as many queries raised by reviewers are related to information usually contained in this document.
  • 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 you have submitted

Whichever review route you are using for Pharmacy Assurance the first step will be a check to ensure your application is complete.

It is also important to note that, in the event of any queries being raised in the course of the Pharmacy Assurance process, you should not make any changes to your study documents; you should only provide clarification in email responses.

The sections below set out the sequence of events when you submit an application for Pharmacy Assurance.



Self-managed studies.

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. The sequence of events is as follows:
  1. You (the applicant) register the trial as self-managed with the HRA (refer to the earlier section on 'How to apply for Pharmacy Assurance').
  2. Within 7 calendar days of you submitting all the required documents to the HRA, they will:
    • Ensure you plan to use HRA-registered reviewers with appropriate specialisms to review the study; and
    • Email you to confirm that the study has been registered for a self-managed review and to 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 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 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 (hra.pharmacyassurance@nhs.net).
  7. The HRA will issue confirmation of Pharmacy Assurance.
  8. You send the completed review and confirmation of the Pharmacy Assurance to participating NHS/HSC sites.




HRA-managed studies (Lead nation must be England or Wales)

For HRA-managed studies, the HRA works with the selected reviewer(s) to complete Pharmacy Assurance for your trial. The sequence of events is as follows:
  1. The HRA will check to ensure that all the appropriate documents have been submitted. You will receive an email confirming when you have met the submission requirements.
  2. The HRA will assign appropriate HRA-registered pharmacy reviewer(s) to complete the technical review. Note:
    • If you submitted the HRA-Managed Study Reviewing Trust / Health Board Request Form, 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 choose to:
      • wait for your requested reviewer(s) to become available and delay Pharmacy Assurance; or
      • request the HRA choose the first available, appropriate reviewer(s).
    • If you have not requested specific reviewer(s) the HRA will select the first available, appropriate reviewer(s).
    • Pharmacy reviewers have the option to refuse to conduct a review (e.g. because they are about to go on annual leave). Where this occurs the HRA will then select the next available reviewer with the appropriate specialism.
    • Where queries arise during the review, the HRA will liaise with you on behalf of the pharmacy reviewer(s) to resolve the query(ies).
    • The HRA will give the reviewer(s) your contact details so that they can contact you directly to arrange payment whilst the review is ongoing.
  3. The reviewer(s) send the completed review to the HRA.
  4. 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).
  5. You send the completed review and confirmation of Pharmacy Assurance to participating NHS/HSC sites.




Studies managed by Northern Ireland

Please contact the HSC R&D Application Gateway (email: research.gateway@hscni.net) for more information about what happens after you have submitted an application to them for pharmacy review.



Studies managed by Scotland

For studies managed by Scotland, the study-wide reviewer allocated by the NHS Research Scotland Permissions Coordinating Centre (NRS Permissions CC) works with selected reviewer(s) to complete Pharmacy Assurance for your trial. The sequence of events is as follows:
  1. When you electronically submit the IRAS Form and associated documents, NRS Permissions CC 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.


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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 hra.pharmacyassurance@nhs.net to submit any feedback or comments on the service.

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Page last updated: 30 September 2019




 
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