Guidance Information. A Learner Agreement is an agreement between Humberside Fire and Rescue Service and an employee undertaking a course or period of development. The agreement between the two parties will be applied in the following circumstances. • Any training course or development programme where the fee for the study period is £1,000 or more in which HFRS outlay the initial costs. The training requirement for the individual will be agreed by the Service, the Individual and Training provider prior to commencement of the course with agreed timescales and expectations for completion. • Programmes of study of 5 days or more. • Study periods which involve release from daily work activity relating to 5 sessions or more. • Fire Service College courses (and other providers for the same course) will be included within the rules of agreement as decided by the Service. Course costs include initial fees, examination fees relating to the training and materials necessary to fulfil the programme. Travel, accommodation and expenses will be paid as per the current Service Guidance. A Learner Agreement is NOT required for the following: • Internal training courses. • Individual study days of less than 5 days. • Courses for which the fee is less than £1000 or less than 5 days study release from work activity. • Conferences and Meetings relating to individual role or references. HFRS will reclaim costs from the individual which may be repaid in full if without valid reason: • The employee fails to attend the course dates as agreed. • The employee fails to complete coursework requirements and/or assignments/portfolio as expected from the study programme, without reasons considered to be satisfactory by HFRS. Or additionally: • The employee is excluded from the course for misconduct. • The employee leaves the service whilst undertaking the course. Costs will also be reclaimed as follows: • If an individual resigns from their employment either prior to completion of the course or within 12 months after the end of the course, except that in the latter case, the amount which would have otherwise be due to the service shall be reduced by 1/12th part for each complete calendar month after the end of the course during which the individual remains employed by the Service. OR • Where there has been considerable individual investment by the Service, for example, Business Safety or Occupational Health positions. These individuals will be required to sign an addendum to contract of employment of between ...
Guidance Information. 5. Appendix 1 – Learner/Training Costs Agreement and Addendum to Contract of Employment
Guidance Information. Budget negotiations will be based on a budget proposal from the SPONSOR/CRO, provided to the INSTITUTION in editable Microsoft excel format. With the exception of participant reimbursement arrangements, the budget must contain all relevant cost items (including the archiving fee and pharmacy budget), along with any conditions and modalities. The pharmacy table must be implemented and integrated in the Agreement as is, (incl. all rows, columns and footnotes), without making any adjustments or changes. As stated in the footnotes of the pharmacy table, the INSTITUTION shall only perform and charge those procedures that are directly or indirectly requested by the scope of the study (e.g. the approved protocol, study-specific manuals, SPONSOR/CRO instructions or other guidance provided). The mutually agreed budget sheet will reference which column of the UZ Leuven “Pharmacy pricing table for commercial clinical research” is applicable under this Agreement. The UZ Leuven pharmacy pricing, as integrated in this Agreement will be valid for the entire duration of the Study. The final mutually agreed upon budget sheet will be converted from excel format to a pdf document and will as such be incorporated in the final pdf-version of the Agreement. SCHEDULE A ANNEX 2: STUDY PARTICIPANT REIMBURSEMENT (CR FIN-TMP-004-2.0_16May2024) Guidance information: Given that it is the SPONSOR’s/CRO’s responsibility to organize appropriate study participant reimbursement (as applicable), the INSTITUTION does not wish to process participant reimbursements on behalf of the SPONSOR/CRO, with exception of bank transfers for foreign study participants (and only in absence of an alternative payment modality). Given the process flow implemented by the Clinical Trial Regulation (and Medical Device Regulation), the INSTITUTION, as participating site in the study, does not have access to the latest information at the time of budget negotiations. As such, and considering that the amount of the participant reimbursement should not, from an ethical viewpoint, be site-specific, there is no need to explicate said amount in the site-specific budget. With regards to the “appropriateness” of study participant reimbursements and the modality/system used to process the payments: please refer to the website of the Belgian Association of Research Ethics Committees (BAREC) for further guidance. Note that: The payment modality/system must be appropriate for the target study population. In observance of GDP...
Guidance Information. We refer to the budget in Microsoft Excel as proposed by the Sponsor/CRO. The final budget excel that was used during the negotiations is converted into a pdf document once this budget can be considered as final for both parties. This pdf-format of the budget is attached to the final pdf contract. Within this Microsoft Excel all budget related items and conditions and modalities (if any) are included, like maximum numbers for eg. screen failures, unscheduled visits,…. Also the archiving fee is included within the budget excel instead of adding an extra narrative payment term in the contract. The pharmacy budget is also part of the Microsoft budget Excel and not part of the main body of the contract. The pharmacy table is to be implemented as is, incl. all rows, columns and footnotes. The fees are fixed and considered non-negotiable. The table is implemented in the exact same way without revisions for all studies and all sponsors without exception in order to promote consistency and transparency for our site's pharmacy costs. Only the procedures that are directly or indirectly requested to be performed for the study (in accordance with the protocol, manual, Sponsor instructions or other guidance) shall be performed and charged, as also confirmed by one of the footnotes.
Guidance Information. Appendix A: Learner/Training Costs Agreement and Addendum to Contract of Employment Appendix A: Section 2: Addendum to Contract of Employment Appendix B: Learner Declaration Appendix C: Reimbursement Costs
