Planning
Good planning makes startup and conduct of clinical trials easier. Here we provide some good advice on what to keep in mind when starting a new industry sponsored trial.
As part of the process leading up to a company’s decision regarding which countries and hospitals should be offered the opportunity to participate in a clinical trial, it is common to carry out a so-called feasibility, i.e. the company sends requests via its local representative to potential investigators to find out if the trialmay be relevant for them.
Questions that need to be answered can be e.g.:
- Is the patient population available?
- Are there competing trials on the same population?
- Does the hospital have the necessary resources (personnel, equipment) to conduct the trial?
- Is the logistics of the trial feasible (are there e.g. lab samples to be taken outside of normal working hours)?
Feasibility inquiries often have a short response deadline. A timely response is important in order to be considered for participation
Participation in externally sponsored research must be authorized by the hospital.
The principal investigator (PI) is responsible for obtaining approval of the trial in his/her own department/division and research group. Routines may differ between departments. Often a research committee in the department or division reviews potential trials and put forward their recommendations. In addition to academic support, it is also necessary to clarify whether one has the necessary resources available to conduct the trial, e.g. study nurses and other staff. If the trial requires participation from service departments (laboratories, radiology, etc.) at the hospital, agreements must also be made with these.
Inven2 manages contractual and financial aspects of externally sponsored clinical trials in South-Eastern Norway Regional Health Authority.
When it has been decided that the study will be conducted by the site and a final protocol is available, the sponsor or sponsor's representative must report the study to Inven2 via an online form. Each study receives a unique project number (M-number). This will be used in all further correspondence with Inven2 as well as in contracts and invoicing.
It is important to contact the service departments early, in order for the sponsor to be able to find another supplier if the hospital does not have the capacity or opportunity to provide the required services. Requests must be detailed so that it is clear what needs to be done, how often, when the study starts, how long it lasts and how many patients will be included. Study protocol and other relevant documentation such as laboratory or procedure manuals should be attached to the request.
Contracts with the service departments must be in place before the study budget can be completed.
Below you find links to price and capacity request forms for service departments, price lists and contact list.
Overview of all analyses offered at Division for Laboratory Medicine can be found here (in Norwegian only): Analyseoversikten.
Accreditation certificates for e.g. the Department of Medical Biochemistry and Department of Pharmacology at OUS are available in English and Norwegian at the Norsk akkreditering website.
Price and capacity request forms:
Price and capacity request form generic (in Norwegian) - not used by Radiology and Nuclear Medicine, Medical Biochemistry or Pathology, see below
Division of Radiology and Nuclear Medicine
Request form for industry sponsored trials
Note: It is not possible to save information in the forms temporarily. If you want a "physical" form, please contact KRNforskning@ous-hf.no or CVL@ous-hf.no
Medical Biochemistry
Price and capacity request form Medical Biochemistry (MBK) - download from OUS eHåndbok (Norwegian)
Pathology
Request form for industry sponsored trials (Norwegian)
Price Lists
Microbiology (Norwegian, excel)
Division of Laboratory Medicine (KRN) Nuclear Medicine (Norwegian)
Division of Laboratory Medicine (KRN) Radiology
Medical Biochemistry - see the department's website (in Norwegian)
Oncology Day Unit (Norwegian)
Cardiology: Echocardiography, NOK 5600
List of contact persons in the service departments:
Contact List (Norwegian)
Once participation and prices are agreed, the trial budget can be prepared. Based on the flow chart in the study protocol, Inven2 sets up a customized budget template which is sent to the Principal Investigator (PI).
The PI is responsible for preparing the budget based on the submitted template from Inven2. The budget should include:
- Estimation of time spent by study personnel for each study visit, as well as for other study tasks such as startup activities
- If the sponsor has delegated tasks such as preparation of local documents for the CTIS application (e.g. subject information / informed consent form), estimated time should be included
- Prices of procedures to be performed by service departments (e.g. lab, radiology, pathology, etc.)
Pharmacy services should not be included in the hospital's budget template. The hospital pharmacies (Sykehusapotekene HF) is a separate health enterprise which requires an individual contract. This is also handled by Inven2.
Completed budget template should be sent to Inven2 with a copy to relevant persons in the hospital (department head, financial manager, etc.)
Inven2 uses the budget as basis for price negotiations with the sponsor.
Feel free to contact Inven2 or Regional Research Support if you need help filling out budget templates and estimating time spent.
Inven2 is responsible for the contracting process with the client on behalf of OUS, including quality assurance of the contract and negotiations with sponsor regarding payment and other conditions. Agreement templates can be found on Inven2's website, but companies can also use their own.
Inven2 coordinates signing of the contract from the responsible person at the hospital (usually the department head), as well as from the PI confirming that he/she has read and understood the agreement.
In the past, the national coordinating investigator (NCI) was responsible for applying to REK (the regional ethics committees). With the introduction of new regulations for clinical drug trials, the NCI role no longer exists. The sponsor submits an application with all associated documents to both the pharmaceutical authorities (DMP) and REK in the CTIS portal.
It is a great advantage if the sponsor enters into an agreement with one site to carry out tasks that were previously the responsibility of the NCI, such as quality assurance of informed consent forms and other relevant information for the trial participants, as well as registration of the study on the hospitals' websites/Helsenorge.
Please note that the quality of the sponsors' subject information/informed consent forms can vary widely. Companies that have operations in Norway and are well acquainted with national routines usually deliver texts of good quality. Other companies translate English-language consents directly, without considering adaptations to Norwegian regulations. It is strongly recommended to use the REK templates for informed consent forms.
NorTrials coordinating unit can help ensure the quality of the informed consent forms in industry sponsored trials.
It is a clear political goal that patients should have the opportunity to participate in new and experimental treatment (clinical trials). For that reason, it is also desirable to cooperate across national borders by arranging for patients to be given the opportunity to participate in trials carried out abroad. A prerequisite for this, however, is that the costs of such participation are agreed in advance and that the responsibility of the patients for any unforeseen events is handled and clarified in separate agreements.
In commissioned (industry sponsored) clinical trials, there are no formal barriers preventing sponsor from paying for the participation of patients with affiliation to another hospital/country. In such cases, the costs for trial participation shall be regulated in the trial agreement as usual, i.e. that the sponsor assumes responsibility for paying all costs in connection with the trial, including necessary travel and accommodation. In addition, it is important that a distinct agreement/declaration of responsibility, for handling unforeseen circumstances and unexpected expenses that are not directly related to the trial, is made between the submitting hospital (where the patient belongs) and the receiving hospital (where the study is conducted). Once this is established, the financial and legal framework for such inclusion and participation will be in place.
When including foreign patients in commissioned trials at OUS, the following applies:
- Hospital/trial unit must ensure that payment for foreign patients is included in the trial budget and the agreement with sponsor
- For the inclusion of a foreign patient, the hospital/trial unit must obtain an agreement/declaration from the submitting hospital that they will bear any extra/unexpected costs associated with transport and required treatment during the patient's stay at the trial unit
- The PI is responsible for emphasizing in the medical record that the stay for the foreign patient applies to a clinical trial. This is to ensure that the patient does not appear on the usual DRG overviews.
A template has been prepared for an agreement/declaration between the submitting hospital and OUS, which can be downloaded here:
The International Centre at OUS can provide assistance with entering into a guarantee agreement. They can also take on responsibility for invoicing any costs related to complications, however this is not mandatory if the division wants to handle invoicing by itself. The International Centre should be notified in advance of foreign clinical trial participants at OUS.
Study participants from abroad are covered by the same insurance schemes as Norwegian participants.
Contact information to the International Centre:
Phone: +47 22118111
Telephone hours: Normal office hours, weekdays
Mail address:
Oslo universitetssykehus HF
Utenlandskontoret
Direktørens stab
Postboks 4950 Nydalen
NO-0424 Oslo
Fill in the online form "Melding til Personvernombudet". You need to upload the study protocol, a copy of the REK/CTIS application and the subject information/informed consent form, as well as other relevant attachments. You will also be asked to provide login links to any electronic questionnaires/ eCRF solutions, if applicable, in order to test whether the web solutions meet information security requirements.
The following applies to data capture solutions and other technical solutions for the collection of health related and personal data:
- Sponsor is data controller for their studies in accordance with GDPR art. 24. This means that the sponsor is responsible for assessing data security in their own projects, cf. GDPR art. 32.
- According to GDPR, it is the responsibility of the sponsor to assess the need for a Data Protection Impact Assessment (DPIA), cf. GDPR art. 35.
- For trials that are to be conducted at OUS on behalf of the sponsor, the sponsor must be able to document the data security assessments that form basis for the choice of IT solutions (art. 32) and document DPIA when necessary (art. 35).
- PI must upload the above mentioned documentation to the online notification form, see eHåndboken. You can also find information about the notification process on our website concerning formalisation of health research projects.
To ensure a fast and efficient internal processing of the notification, it is recommended that the sponsor gives PI access to all relevant documentation that confirms that sponsor has fulfilled their responsibilities in accordance with the above provisions. In order to further contribute to efficient case processing - especially in complicated studies with considerable data collection or using several data capture solutions - it is recommended that a plan for data flow is prepared, where data and data capture tools are described in more detail. If a data management plan according to GCP has been prepared for the study, this can be used as a basis together with documentation of data security assessments carried out (GDPR art. 32 and/or art. 35).
The Data Protection Officer and Chief Information Security Officer have a responsibility to report back to PI and/or the sponsor if there is a need for further clarification/documentation.
All prospective clinical trials conducted at Oslo University Hospital HF (OUS) must be registered in a publicly available, approved database before the project can start, i.e. before the inclusion of the first patient in the trial.
All clinical drug trials subject to application within the EEA area must be registered in CTIS for trials that follow new regulations, and in the EU Clinical Trials Register (EU CTR) for those that follow old regulations. Other clinical intervention and observational studies should be registered in ClinicalTrials.gov. In industry-initiated trials, the sponsor takes care of this registration.
Clinical treatment and rehabilitation trials which may affect the treatment course of the trial participants and which are open for inclusion, or where REK approval is available and a start date has been set, must be published on the hospital's website. Trials registered here will be listed under the webpages for relevant treatments, as well as in an overview of all registered trials in all Norwegian hospitals. The content is also mirrored on Helsenorge.