Landspitali - University Hospital
Clinical research center
Drug study
Clinical pharmacovigilance is a systematic study of a medicinal product with the purpose of gaining knowledge or confirming knowledge of efficacy, interactions, adverse reactions, pharmacokinetics or investigating therapeutic value.
It is important that the principal investigator has the facilities, time, staff, and a sufficient number of participants to carry out the study.
Attention must be given to the research protocol, including the SPIRIT guidelines for writing a study protocol.
Essential documents, such as participant information sheets and informed consent forms, must be prepared.
Measurement tools, such as questionnaires, must be translated and adapted.
Equipment used must be inspected and calibrated.
Requirements for monitoring and recording temperature during the storage of samples and investigational medicinal products must be met.
Regulation and guidance in Icelandic
Landspítali offers financial administration for research projects conducted by its employees. The project must be registered in the hospital’s accounting system.
The project’s principal investigator must send a completed form (pdf) to the financial manager at the Office of nursing and medicine at the following email address: eyrunst@landspitali.is.
The same rules apply to employee research funds as to public financial administration. If the researcher is also employed by the University of Iceland, another research institution, or a company, that institution may be entrusted with managing the funds.
Request for financial administration
Request for data storage space
Hiring staff
If staff are to be hired for a research project, it must be ensured that funds are available for the payment of wages and related salary costs, and that approval from the relevant department head/chief physician/unit manager or managing director at Landspítali has been obtained.
The employment must comply with Landspítali’s rules and salary classifications. The person with the authority to hire in the field where the employee will work must sign the employment contract.
The employment contract should be timed so that the employment is subject to the funding of the scientific research. These fixed-term positions can last for a maximum of two years, as set out in the rules on temporary employment for government employees in the Act on the Rights and Obligations of Public Servants.
In the case of contractor payments, the signatory/principal investigator of the research project must ensure that funds are available and approve the payments.
Hospital employees
A principal investigator or their colleagues/assistants working at Landspítali may receive payment for their contribution to research carried out at the hospital, provided it is outside their regular working hours there. The percentage of working time to be devoted to the research, both within and outside regular working hours, must be specified if payment is expected for the work. This must be done in consultation with the relevant supervisor.
All handling of funds must be in accordance with Landspítali’s rules on financial administration.
Other Permits
Before applying for a research permit, approval from the head of department for the execution of the research must be secured (.pdf).
Permits Required Before Research Begins:
Clinical Trial Authorization (CTIS Portal)
Instead of applying to the Icelandic Medicines Agency and the National Bioethics Committee, permission to conduct a clinical trial must be sought through the CTIS portal.
CTIS (Clinical Trial Information System) is a pan-European portal for the application, assessment, and supervision of clinical trials. This applies equally to clinical trials planned exclusively in Iceland as well as multinational studies in more than one EEA country. Only one application is submitted to the portal for all countries involved.
More detailed information can be found on the Icelandic Medicines Agency's website.
Other permits
As applicable, the Icelandic Cancer Registry
If ionizing radiation is used in the study, an application must be submitted to the Icelandic Radiation Safety Authority
If biological samples from a biobank are to be requested, an application must be submitted for this
In the case of partners outside Landspítali, a contract shall be concluded between Landspítali and the partners. Examples of partners are pharmaceutical companies, Primary Care Center (Heilsugæslan), various research institutions and foreign universities and hospitals.
If the services of other units of Landspítali are to be used, the investigator must contract with the relevant unit regarding service and payment.
Blood test. If the services of the National University Hospital's Research Department are to be used for a scientific study, the responsible party shall conclude an agreement with the department regarding services and payments. The Chief Medical Officer of the Research Core is Ísleifur Ólafsson.
Imaging. If the services of the imaging department are to be used in a scientific study, the responsible person shall conclude an agreement with the department regarding services and payments. The Chief Physician of the X-ray department is Pétur Hörður Hannesson.
A pharmacy. If the services of a hospital pharmacy are to be used for a scientific study, the investigator must make an agreement with the pharmacy regarding services and payments. The chief pharmacist of the hospital pharmacy is Tinna Rán Ægisdóttir.
The sponsor of the study is responsible for the participants' insurance. In the case of an academic study (without sponsor), the participant is insured against possible harm from a study drug with patient insurance no. 111/2000.
The relevant institution must issue a statement confirming that the study is a clinical drug trial without a sponsor.
If the study is academic, the Chief Medical Director at Landspítali will issue such a statement.
Halla Sigrún Arnardóttir (hallarn@landspitali.is), project manager at the Clinical Research Center (KRS), acts as an intermediary for obtaining the statement. .
The investigator is responsible for training the investigating staff.
All pharmaceutical research staff should be trained in GCP
The training is useful in all scientific research on humans.
Generally, GCP training is required to be updated every 2-3 years.