The Health Research Authority has recently introduced the UK Local Information Pack, a key component of which is the Organisation Information Document (OID), which replaces the Statement of Activities that were used in England and Wales for non-commercial studies, and the NHS/HSC Site Specific Information (SSI) Form that were used in Northern Ireland and Scotland. Please click here for more information.
Please carefully read the guidance below on how to complete the OID. Where specific guidance on a question is not given below, please refer to the OID guidance on the IRAS website.
Note: The OID guidance is very specific with respect to version control and file naming. Please read the guidance and ensure that you have used the correct file name and footer formatting.
Question 3: the legal name of the sponsor is Lancaster University
Question 4: Becky Gordon’s details should be entered: Becky Gordon, Head of Research Quality and Policy, Lancaster University, Tel: +44 (0)1524 592981 and e-mail address: firstname.lastname@example.org
Question 8: please carefully read the OID guidance when completing this question.
Question 10: please note that the OID guidance states that, for many studies, the detailed dates requested may not be applicable (N/A) and this may be stated in answer.
Question 12: Complete this question with advice from the site(s) you are working with regarding anything required to successfully set up and deliver the study.
Question 13: Please use the following text in answering this question “Lancaster University provides online research integrity training, available to all staff and research students, as well as mandatory information security training. Researchers can also access a range of relevant training programmes through the University’s Organisation and Educational Development division.”
Question 14: Please use the following text in answering this question:
If your research is NOT a clinical trial: “The Sponsor expects that researchers complete any training relevant to the proposed area of research (e.g. any relevant clinical training, or training relating to the use of specific equipment/devices/questionnaires including but not limited to the PANSS, SCI-PANSS, MINI and Y-BOCS) before research commences.”
If your research is a clinical trial: "Researchers undertaking a clinical trial, must renew their Good Clinical Practice (GCP) training every two years. The Sponsor also expects that researchers complete any training relevant to the proposed area of research (e.g. any relevant clinical training, or training relating to the use of specific equipment/devices/questionnaires including but not limited to the PANSS, SCI-PANSS, MINI and Y-BOCS) before research commences."
Please note if you are undertaking a clinical trial you will be asked to provide evidence of your most recent GCP training completion as part of university governance checks before approval.
Appendix 1 General Provisions: Please select Organisation Information Document.
Please delete clause 2.15 from the document.
Appendix 2 Finance provisions: please complete as appropriate to your study/project
Appendix 3 Material Transfer Provisions: please complete as appropriate to your study/project
Appendix 4 Data Processing Agreement: Please note in the OID guidance documents the comment on Clause 5.(b): “If the participating NHS / HSC organisation will not be receiving referrals from Participant Identification Centres (PICs) for the study, the yellow highlighted text at 5, b should be deleted prior to sharing with the participating NHS / HSC organisation (this may be removed before submitting the outline Organisation Information Document in IRAS, where no organisations to come under the document will use PICs). Similarly, where the participating NHS / HSC organisation will be sub-contracting data processing to PICs but each such PIC sub-contract must be agreed individually in advance by the Sponsor, the yellow highlighted text should be removed. The yellow highlighted text should be retained, and the highlight removed, only where the Sponsor is authorising the participating NHS / HSC organisation to sub-contract with PICs without the Sponsor approving each individual sub-contract in advance (albeit that the participating NHS / HSC organisation will notify the sponsor of new PICs in advance of activating their PIC activity).”
Appendix 5 Data Sharing Agreement: Please complete as appropriate to your study/project
Appendix 6 Intellectual Property Rights: Please complete as appropriate to your study/project, noting our definition of IP in Step 4 'Lancaster IRAS guidance'.
You will also need to complete either a Schedule of Events OR a Schedule of Events Cost Attribution Template (SoECAT). Please refer to the guidance on the IRAS website and complete one of these as appropriate to your project.