Content
Introduction
1. Creating a minimal dataset
2. Setting up new sites
2.1. To create SSI Forms
2.2. To create ARSAC Forms
3. Submitting Amendments
3.1. To create an Amendment Form
3.2. Amendments to Clinical Trials of investigational medicinal products (CTIMPs)
Introduction
The minimal dataset functionality was introduced in August 2009 to allow those who had applied in systems that pre-dated IRAS to create site specific information forms and manage amendments to their projects.
The implementation of IRAS v5.3.2 in September 2016 removed the option to create new minimal datasets. This change was made because:
- The restricted role of minimal dataset projects meant that the functionality provided within them is also very limited when compared with full projects, which may limit usefulness to ongoing projects e.g. where an updated application form is be needed.
- It has been several years since IRAS became the preferred system for applying to the review bodies whose applications are included in the system and the minimal dataset functionality was introduced. Therefore it is expected that minimal datasets have now been created in all cases where they are needed (i.e. for projects that pre-date IRAS).
Any minimal dataset projects created prior to the IRAS v5.3.2 release will remain available in IRAS accounts and may be identified by text in the header area of the Navigation Page for the project which states "created as a minimal dataset". Please note that if responsibility for the project has changed since the minimal dataset was created then ownership of the project may be permanently transferred to another IRAS account holder - please refer to the IRAS e-learning module for instructions.
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1. Creating a minimal dataset
As set out in the introduction above, it is no longer possible to create new minimal datasets. If you have an existing minimal dataset project please refer to the relevant section(s) below for more information on how to use this type of project in IRAS to prepare applications.
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2. Setting up new sites
You may need to create SSI Forms if you wish to set up any new NHS site, or a new non-NHS site that requires Site-Specific Assessment. Please refer to IRAS guidance on site-specific information.
2.1. To create SSI Forms
- Select the minimal dataset in the main Navigation page
- Complete Part A of the minimal dataset only
- If you will also need to create an ARSAC form for the new site, complete Part B Section 3 of the minimal dataset as well
- Select the Add SSI tab, visible on the right side of the screen
- Create the required number of forms
- Select the SSI Form in the main Navigation page and make sure the Navigate tab is selected in order to complete the form
Guidance on requirements for Site-Specific Assessment for non-NHS sites is available within the question-specific guidance on the SSI Form for non-NHS sites, and on the Health Research Authority (HRA) website resource page .
2.2. To create ARSAC Forms
- Follow the guidance above for creating an SSI Form, ensuring you also complete Part B Section 3
- Select the SSI Form in the main Navigation page
- Complete the SSI Form
- Select the Add ARSAC tab, visible on the right side of the screen
- Create the ARSAC Form
- Select the ARSAC Form in the main Navigation page and make sure the Navigate tab is selected
- Complete the open fields in the form
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3. Submitting Amendments
3.1. To create an Amendment Form
- Complete the project filter only
- Select the minimal dataset in the main Navigation page
- Do not complete any sections of the minimal dataset
- Select the Amendments tab
- Click on Create Notice of Substantial Amendment
- Select the Amendment Form in the main Navigation page and make sure the Navigate tab is selected in order to complete the form
- Complete all sections of the amendment form that are enabled
Answers to the first question in Parts B and C will determine whether further questions in those sections need to be completed. Complete all the questions in the amendment form that have been enabled. Where questions in Part B or C are enabled in the minimal dataset, these are incorporated into the amendment form since it is not possible to amend the original REC form to provide these details.
There are specific arrangements for amendments for clinical trials of investigational medicinal products when using the minimal dataset. Please see below.
3.2. Amendments to Clinical Trials of investigational medicinal products (CTIMPs)
For all CTIMPs, substantial amendments must be notified to the main REC and the MHRA using the European Commission form, available on the EudraCT website (refer bullet point labelled "Substantial Amendment Notification Form" in second sub-bullet point of Chapter 1 section on webpage). For CTIMPs only, addition of new research sites or changes to the local Principal Investigators listed in Part C of IRAS qualify as substantial amendments.
For studies originally submitted for review by the REC using an application form prepared in the NRES form system please also submit the additional amendment form generated by IRAS in the following circumstances only, and submit this to the REC along with the EudraCT Notice of Substantial Amendment Form. The additional form replaces the need for an amended REC Form in these circumstances. It is not necessary to submit this additional form to the MHRA.
Please use the additional Notice of Substantial Amendment form:
- Where the amendment involves new types of exposure to ionising radiation or increased exposure
- Where the amendment involves inclusion of adults lacking capacity for the first time or a change to the arrangements relating to adults lacking capacity
- Where the amendment involves addition of new site(s) or a change to local Principal Investigator(s)
Please submit a single hard copy of the relevant forms to the main REC, together with all relevant enclosures.
More information about amendments is provided on the Amendment tab.
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Minimal Dataset Guidance
Version - 2.0 Updated September 2016.