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’s representative must reply promptly to all correspondence and contacts concerning the project.
Starting a new research project:
The commissioning party should submit the following electronic documents concerning the planned research project:
- research protocol
- draft research agreement prepared by the sponsor and
- a draft research budget, if available, together with
- a laboratory manual, if required.
- In addition, the details of the contact person/HUS researcher, and
- the current status of project permit processing (ethical committee statement).
- Due to the new EU General Data Protection Regulation, it is also important to submit a patient briefing during the research preparation phase.
Appointing the responsible Study Management Coordinator:
Once the aforementioned written background material has been submitted to the Institute, the Head of Research Services appoints a Study Management Coordinator for the project from his/her team (based on the current workloads of the Research Service Team) and informs the responsible person and sponsor and the primary investigator.
Research project processing phases at Clinical Research Institute HUCH:
When project processing begins, the Study Management Coordinator agrees on a kick-off meeting with the research team, at which they discuss issues such as the roles and responsibilities of different parties (investigator/the Institute), the schedule and objectives of the study, the costs of the study, remuneration of the study team and the content of the study / trial agreement. At the same time, they review the contents of the study protocol and make additional clarifications 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. After that, the Study Management Coordinator prepares the study budget to be administered in the application on the basis of the study service requirements in line with the study protocol, the profit unit service fees and the remunerations/salaries agreed on with the research team. The Study Management Coordinator submits the draft budget to the primary investigator for approval, and then to the sponsor. The agreed study expenses and the terms and conditions of payment are entered in the draft research agreement by the Study Management Coordinator.
The Clinical Research Institute’s service margin is 18 %. A non-refundable start-up fee of 1000 Euros will be invoiced with every new research project and 150 Euros per each amendment to an Agreement.
Negotiating study agreements:
The Study Management Coordinator and the contract lawyer of the Institute review the draft study agreement submitted by the commissioning party. Any corrections and amendments required to the agreement by our contract lawyer in accordance with HUS and Finnish/EU acts and decrees are negotiated by the responsible Study Management Coordinator with the sponsor. Once all the details of the agreement have been completed and fine tuned, the contract lawyer of the Institute does a final review of the agreement before it is signed. The Study Management Coordinator obtains signatures from the parties to the study agreement and saves the agreement in the electronic Tutkijan Työpöytä application with the other documentation of the project.
HUS hospital/Research Services invoicing:
Different HUS profit units (HUSLAB, Medical Imaging Center, etc.) invoice Clinical Research Institute HUCH on a monthly basis for research services used and on the basis of internal HUS project entries made by the research team in question. The Financial Administration of the Institute allocates these project-specific HUS costs as expenditure on the project.
Invoicing the sponsor / CRO-company:
Agreed-on start-up costs are invoiced from the sponsor / CRO-company once the research project agreement has been signed. Payments received from the sponsor / CRO are allocated as income for the research project in question. During the research phase, the sponsor / CRO-company is most often invoiced on a quarterly basis on the basis of actual patient visits and additional costs incurred. The grounds for invoicing the sponsor / CRO-company are compiled in the electronic Tutkijan Työpöytä application and in accordance with the visits reported by the research team to Tutkijan Työpöytä.
HYKScoordinators (at) hus.fi
Clinical Research Institute HUCH’s Study Management Coordinators provide information on the administration of external study funding and prepare study agreements and budgets in cooperation with the researcher, the sponsot/financier and the Research Service Team lawyer.
Preparation of a research agreement is generally started when a sponsor or future lead researcher contacts Clinical Research Institute HUCH by email.
Further preparation of the research project is carried out by and under the firm supervision of the appointed Study Management Coordinator. The appointed Study Management Coordinator serves as the coordinator and contact person for the new research project on behalf of Clinical Research Institute HUCH during the entire duration of the research and also supervises the invoicing of the sponsor / CRO-company.
Termination of the research:
When the research project ends, the sponsor/lead researcher must submit a study termination notification to the Study Management Coordinator at Clinical Research Institute HUCH. The final invoice to the sponsor / CRO-company can be drafted on the basis of this notification. Agreed-upon archiving of research materials will also be invoiced at that time.