In order for Isis to prepare a copyright licence for the use of one of our PROs we require certain information from you and/or your organisation. We therefore ask that you complete the Licence Request Form so we can prepare a licence for your proposed use.

The information you provide will be relied on and used by Isis for any licence agreement that may subsequently be issued to you. Please therefore ensure that it is complete and accurate. The information will be received and held in confidence and used by Isis solely for the purposes of the prospective licence agreement and interactions with you. Isis’s privacy notice can be accessed here.

On submitting your licence request form you will receive an automated response confirming that your licence request has been received. A member of the Isis Outcomes team will endeavor to respond to your application within 1 working day. If a request is urgent then please do let us know and we will endeavor to respond as soon as we receive the completed Licence Request Form.

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Yes, you must acquire rights (licence) or permissions for any use of the PROs, whether it is commercial or academic research. The PROs are protected by copyright and are available for licensing from Isis Innovation Ltd. If your use involves reproducing the PRO in a research paper then you should still seek permissions from Isis.

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The payment (or not) of a licence fee depends on the proposed use. The fee will depend on factors such as:

• whether the use is a commercial study or an academic study;
• how many times the PRO will be used in the study;
• language requirements.

Strictly non-commercial academic licences are provided free of charge. Please complete an online Licence Request Form or contact one of the Isis Outcomes team who would be pleased to discuss your study requirements and provide a quote.

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No. The licenses we provide are study-specific. This means that any organisation wishing to use an Isis PRO must apply for a separate licence for each study. For clarity, you do not need to apply for a separate licence for each trial site that is part of the same study; the usage across all sites will be aggregated in the one licence agreement.

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We recognise that complex studies often involve a multitude of organisations each bearing responsibility for delivering different aspects of the study. Our standard licence accommodates this by permitting the licensee to sub-licence to their affiliates, principal investigators and their teams, study trial centres, CROs and CRAs in each case who are directly associated with the performance of the study.

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Isis provides licences to our portfolio of PROs in an efficient manner, so we can minimise the costs of providing licences to our users, keep prices down, and ensure that we return as much revenue as possible to the University of Oxford. Some of the money returned to the University goes directly into supporting further PRO research and development at Oxford. For these reasons we use a Standard Licensing program at Isis which we can only operate if there is consistency between licences. For this reason we will be happy to amend licences to correct errors and provide clarity, but will not accept other changes to our Standard Licence.

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Isis Outcomes is an activity within Technology Transfer, a part of Isis Innovation (the Licensor), the Technology Transfer company for the University of Oxford. We work with our academic authors to licence the copyrighted material they produced. With the academic authors support, Isis formally acquires rights in the PROs from University of Oxford. Therefore, as Isis is the copyright owner of the PRO the licence you enter into is with Isis Innovation as the Licensor.

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For all of the Oxford PROs, patients should be assessed at least twice using the PRO – once before surgery/treatment and at least once following surgery/treatment. The reason for this is that the absolute score is not necessarily the relevant information; it is the change in the patient's score from the pre-therapy to the post-therapy evaluation which is the critical factor in patient assessment. The Isis PROs have been designed, tested and shown to be responsive to change in health status. There is no limit to the number of post-operative assessments that can be made; the number of times patients should be assessed will largely depend on the nature and purpose of the study.

The developers of the PROs available from Isis are happy to consult with organisations who require support on study design including the optimal timing of pre-operative or post-operative patient assessment. Please contact one of the Isis Outcomes team if you would like to discuss consultancy support.

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All Isis PRO measures have undergone rigorous testing so we have confidence that the instrument can be used in particular specified contexts. It is the responsibility of the user to ensure the PRO measure adopted for their study is suitable and appropriate, but Isis can assist potential users with such assessments.

We provide information and results of the testing that has been undertaken on our PRO measures. We also guide potential users to journal publications (and our own user manuals) that provide further details on the testing that has been applied to our PRO measures.

If you would like to get further advice on this question of validity and suitability of a PRO measure to meet your specific study requirements, then please do enquire. This PRO review service is available for our own instruments and for third party PRO measures.

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In general the PROs may not be modified. All PROs are protected by copyright. Any change made without the prior written consent of Isis is a breach of copyright.

Also, modifying a PRO (for example by changing, deleting, or adding items) can damage the validity of the instrument so any results obtained using the modified PRO may not be reliable or statistically relevant.

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The conditions for which each PRO is validated are listed on the PRO-specific web pages.

If your organisation wishes to use the PRO to assess patients with a condition for which it is not validated, this is done entirely at your organisation's own risk. We highly recommend that a new validation study is conducted on the PRO in the target patient group prior to commencing the actual study. Please contact one of the Isis Outcomes team if you would like to use the instrument for any purpose for which it is not validated. Our developers may be able to assist you with the validation study.

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Any data generated in a study using an Isis PRO shall belong solely to the Licensee. Isis shall have no legal interest in the data and does not require access to the data generated under the study.

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Translations are available for many of the PROs. You can find complete lists of the translations available for each of the PROs on the relevant web pages.

If you require a language that is not available, then Isis will support you in obtaining the required translation. Isis’ standard licence does permit licensees to translate the PRO, subject to that translation following Isis' own Translation and Linguistic Validation Methodology, developed in association with PharmaQuest Ltd (external link). Any translations undertaken by licensees must follow our methodology which uses industry best-practice in line with ISPOR’s Good Outcomes Research Practices (external link). In this way, Isis can continue to provide PROs of the highest quality.

Any translations generated in connection with the licensee’s permitted use of the PRO shall be the property of Isis Innovation Limited and formal assignment of rights will be required.

If you have not previously worked with translation companies and you would like to commission a translation of an Isis PRO, we can manage this process for you. Isis works with industry-leading providers of PRO translation and linguistic validation services to ensure that the integrity of the instrument is maintained following translation of the PRO.

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Yes, Isis can assist in a number of ways depending on your requirements and the availability of suitable PROs:

i) Isis can, working with our researchers who are experts in the field of PROs, provide advice on suitable PROs for your study and how they may be best used.

ii) If a suitable condition-specific PRO does not exist for your study requirements, then Isis can advise on the development of a PRO for your study.

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Once you submit your completed Licence Request Form (LRF) you will receive an automated response from Isis acknowledging receipt of your request. This does not give you the rights to use the PRO measure yet; you require a formal countersigned licence agreement from Isis. Your licence request is forwarded to Isis who will then respond in a timely manner by either:

i) Emailing you a licence for your signature (or an authorised signatory) using the deails you have supplied in your LRF, or

ii) We may request further information and will contact you directly to discuss.

It is important that the LRF is completed as fully and accurately as possible as this makes the whole process faster. When we email you the licence (as an attached file) Isis will also send instructions for completing the licence.

The information you provide will be relied on and used by Isis for any licence agreement that may subsequently be issued to you. Please therefore ensure that it is complete and accurate. The information will be received and held in confidence and used by Isis solely for the purposes of the prospective licence agreement and interactions with you. Isis’s privacy notice can be accessed here.

Once the licence is executed (signed by both parties) Isis will send you a copy of the fully executed licence for your records, any copies of the questionnaire (including required language versions where available) for your study and the user manual (if available) for the PRO. The actual PRO measure is sent as a Microsoft Word file.

Please note you should not use the questionnaire until you have paid the fee (if applicable) for the licence. If you have any language version requirements for your PRO measure use that don’t currently exist, then Isis will contact you using any of the contact details you have provided.

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You can find more information about each of the PROs, including references to journal articles and other literature materials, on the PRO-specific web pages.

If you are unable to find the information you require on our website then please don’t hesitate to contact one of the Isis Outcomes team.

Isis can provide further information on our PROs in the form of PRO dossiers. These are available on request and can, for example, be used in support of regulatory submissions.

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