All externally funded research conducted at HUS that involves HUS patients and/or resources is administered at Clinical Research Institute HUCH.
All externally funded research conducted at HUS that involves HUS patients and/or resources is administered at Clinical Research Institute HUCH. The research agreement is concluded between the research sponsor and Clinical Research Institute HUCH, and the agreement is signed by the CEO of Clinical Research Institute HUCH and the representative of the research sponsor.
Research Agreement and Budget Preparation Process
The researcher and the contact person responsible for agreements at the company/other external organization must ensure that sufficient time is set aside for the drafting of the agreement (usually one to three months) before the planned date of submitting the hospital research permit and starting the planned research.
A research agreement and research budget often require lengthy negotiations with both the researcher and sponsor. These negotiations are generally held by email and over the telephone. To ensure rapid progress in research projects, the primary investigator and sponsor must reply promptly to all correspondence and contacts concerning the project.
Starting a New Research Project
Preparation of a research agreement is generally started when a sponsor or future principal investigator contacts Clinical Research Institute HUCH. The Head of Research Services compiles the relevant research background information and supporting documents required for the research agreement and budget and appoints a Study Management Coordinator for the research.
The sponsor should submit the following electronic documents concerning the planned research project:
- Research protocol
- Draft research agreement prepared by the sponsor
- Possible draft research budget together with a laboratory manual, if required
- Details of the contact person for the commissioning organization / HUS researcher
- Current status of the project permit processing (statement from the ethics committee)
- Due to the new EU General Data Protection Regulation, it is also important to submit a patient briefing during the research preparation phase
Research Project Processing Phases
When the project processing begins, the Study Management Coordinator schedules a kick-off meeting with the research team. In the kick-off meeting, a discussion will be held on the roles and responsibilities of the various parties (researcher / research nurse / Clinical Research Institute HUCH), research schedules, objectives, costs, remuneration of the research team, and the content of the research agreement. At the same time, the contents of the research protocol will be reviewed and additional clarifications made as necessary.
The Study Management Coordinator opens an internal project number at Clinical Research Institute HUCH for the new research project and creates the project in the electronic Tutkijan Työpöytä application (Researcher’s E-desk).
After this, the Study Management Coordinator prepares the research budget in the Tutkijan työpöytä application on the basis of the profit unit service fees and the remunerations/salaries agreed on with the research team in accordance with the research protocol.
The Study Management Coordinator submits the draft budget to the principal investigator for approval, and then to the commissioning party / sponsor. The agreed research expenses and the terms and conditions of payment are entered in the draft research agreement.
Negotiating Research Agreements
The Study Management Coordinator conducts the contract negotiations with the commissioning party in connection with the proposed research agreement, utilizing the help of the contract lawyer of Clinical Research Institute HUCH when necessary. As a result of the contract negotiations, a signed research agreement is created, which, in addition to the research protocol, includes the final research budget and the terms of invoicing the research sponsor.
In the research agreement, the actual contracting parties are always the sponsor commissioning the research and Clinical Research Institute HUCH. The project’s principal investigator (PI) also signs the research agreement. This will ensure the commitment of all parties to the responsibilities and obligations regarding the research.
The research agreement negotiated by Clinical Research Institute HUCH is also needed to apply for the final HUS research permit. When planning the start of a new study, the researcher is responsible for preliminary determination of the availability of HUS research nurse resources and HUS special services (such as pathology and imaging services) needed during the study. In the research permit application, the principal investigator informs of the use of the required HUS services.
Invoicing the Sponsor / Commissioning Party
Agreed-on start-up costs are invoiced from the sponsor once the research project agreement has been signed. During the research phase, the commissioning party is often invoiced on a quarterly basis on the basis of actual patient visits and any additional costs incurred. The grounds for invoicing the commissioning party are compiled in the electronic Tutkijan työpöytä application and in accordance with the study visits reported by the research team through Tutkijan työpöytä.
Termination of the Research
The principal investigator must inform the research project’s Study Management Coordinator without delay when the research is interrupted or terminated. After receiving a notification about the termination of the research project, the Study Management Coordinator starts preparations for generating the final invoice for the project. After the project’s final invoice is generated, an * symbol is placed in front of the project name. This indicates that the final invoices have been made for the research project, and that there are no more revenues coming for the project.
After receiving the study termination notification, the principal investigator is obliged to check without delay that all the final entries are in order in the Tutkijan työpöytä application so that final invoicing for the project can be carried out appropriately. The last entries should be made without delay, as sponsors often close the centers quickly in their own systems.
After the closure of the research center, the sponsors will no longer pay the costs incurred in the research project, even if the costs have been incurred during the project. At the end of the research project, all data transfer of research data to the sponsor also ceases. In Financial Administration, a project is terminated when the project balance is zero.
At the end of the research project, the research materials will be archived. Some of the commissioning parties take care of the archiving themselves, but some acquire it as part of the research project from Clinical Research Institute HUCH. In this case, the principal investigator is responsible for packaging the archived materials and ordering delivery from the archiving service company used by Clinical Research Institute HUCH.
A copy of the list of materials will be submitted to . Clinical Research Institute HUCH invoices the sponsor for the costs of archiving and takes care of the costs of archiving for the entire statutory retention period of the data (clinical trials 15 to 25 years and device studies 5 to 15 years). More detailed instructions on archiving at Archiving page.