LMI is regularly in contact with the hospitals about what guidelines the pharmaceutical industry’s employees must adhere to in connection with the implementation of their clinical studies, with associated monitoring visits and the like.
– It is gratifying that the conduct of clinical trials is approaching the norm to a greater extent, and we hope that the activity can remain close to normal even in the event of a pandemic. We have gathered general information from the hospitals in this case, but since different departments have different guidelines, it is important that the companies follow up the dialogue with the relevant departments they study in, so that they always follow current guidelines, says Hege Edvardsen, senior adviser at LMI.
Most hospitals state that they are now on green alert, and resume regular operations as far as possible, while taking a number of precautions and being prepared to receive COVID-19 patients. Most hospitals recommend remote monitoring as much as possible, but accept physical monitoring visits according to certain criteria. Everyone naturally expects that general infection control rules are followed, and some introduce requirements for face masks in certain situations. Here is an overview of information we have received from the various hospitals and research posts:
Oslo University Hospital
Oslo University Hospital (OUS) is on green alert. They want to facilitate that the research activity can be maintained as much as possible during the pandemic. OUS ‘e-handbook procedure contains a detailed overview of current guidelines.
It states, among other things, that monitoring, audits and other physical visits should be limited to a minimum, and with a maximum of three external participants. Monitoring visits must be arranged in advance and approved by the main examiner (PI) at OUS, and the nearest manager where the study is based. Visitors must meet on arrival and be escorted to a meeting / monitoring room, stay in a designated place during the entire visit, and to the extent possible carried out in premises that are not considered close to patients. Food and drink must be brought by a monitor, possibly procured by the person in charge at OUS if this has been agreed in advance. Any contact with personnel in OUS must follow infection control rules at a distance of at least 1 meter. If the contact lasts for more than 15 minutes, a distance of at least 2 meters is recommended to avoid triggering a quarantine obligation. Monitoring is limited to necessary review of documentation that is not possible to access in any other way. For drug studies, recommendations for monitoring by the Norwegian Medicines Agency apply. These allow in certain cases for source data verification via «remote SDV», e.g. via video conference or the like. When using such solutions, all parties involved must ensure that the study participants’ privacy is safeguarded. This solution must be agreed in advance with the study center.
See the entire chapter of the e-handbook procedure on Monitoring visits and other visits from the sponsor in connection with clinical assignment studies in the event of a visit ban / control.
Akershus University Hospital
Akershus University Hospital (Ahus) is no longer on green alert in connection with the outbreak of coronavirus. Developments are closely monitored. Visit control still applies, and monitor visits must be approved by the department head in advance. In addition, the monitor must provide a self-declaration. Monitoring visits from abroad are not recommended in principle. If the monitoring is absolutely necessary, the monitor can come visiting from a green or yellow country / region. Visits from red countries / regions with increased infection are not permitted. National travel regulations and quarantine requirements apply at all times. Monitors from abroad must use face masks in close contact with employees / study staff, in addition to other infection control measures. Ahus also has a dedicated room set aside for monitoring visits so that this can be carried out outside the clinical departments.
Haukeland University Hospital (Helse Bergen)
Haukeland University Hospital recommends remote monitoring as far as possible, but monitoring visits from partners from countries that do not trigger a quarantine obligation («yellow» countries) can be carried out if absolutely necessary. On-site monitoring visits may be permitted if the following criteria are met:
– Monitor only stays in rooms other than patient rooms
– Any keyboard / mouse used is sprayed off before and after the visit
– Follow normal infection control rules (distance, hand hygiene, etc.)
– Monitor uses face masks in meetings with employees and when it is difficult to keep a distance of 2 meters (cf. def. Close contact with infection detection)
– National infection control recommendations are complied with before, during and after the monitoring visit (cf. travel regulations and quarantine requirements etc.)
– Written confirmation is available that the visit (time / duration) has been cleared with the study center – Monitor relates to a contact person
– The visit is carried out within normal working hours Signed self-declaration of infection from monitor is available Furthermore, it is required that the monitor during the last 10 days has not been abroad, had close contact with people who are infected with corona or have signs of fever, respiratory problems or other symptoms associated with corona infection.
Stavanger University Hospital
Stavanger University Hospital is on green alert and opens up for assessment of new clinical studies. However, there may be less activity in some departments than in a normal situation. Studies that are considered important for patients who would not otherwise be able to receive similar treatment options, and studies where vital treatment is made available for seriously ill patients, will continue to be a priority.
Ongoing clinical trials will gradually be able to return to normal operation. Study visits with physical attendance can be performed after careful pre-screening for Covid infection in accordance with the hospital’s routines, and visits are carried out in accordance with the current infection control regime. For study patients in quarantine, treatment is postponed if this does not lead to a significant loss of prognosis or critical worsening of symptoms.
Monitors from Norway are given the opportunity to come, but it must be agreed with the manager, and one must follow the infection control rules updated at all times. National travel regulations and quarantine requirements apply at all times. Prior to arrival, the monitors must provide a self-declaration. Monitors are placed in premises without connection to patients. They cannot visit canteens or other places where they can meet patients.
University Hospital of Northern Norway
The University Hospital of Northern Norway is on green alert. Initiation of new clinical trials is delayed or limited, with the exception of COVID-19 studies. Recruitment of patients for ongoing clinical studies is assessed and prioritized by the study supervisor and management in each unit based on the capacity available, both at their own department and at collaborating departments. Monitoring will primarily be remote monitoring, but this is agreed between the study team and the sponsor / monitor. Those who are interested in status in relation to clinical commissioned studies, are welcome to contact kliniske.oppdragsstudier@unn.no.
St. Olavs hospital
At St. Olav’s hospital, the individual clinic manager assesses whether the clinic wants to start the specific project with a focus on infection control assessment. A prioritization will be made based on the scope of the study, whether the study involves a call for an examination / consultation with a physical attendance that otherwise would not have been made and any need for the use of infection control equipment. In the event of any additional consultations in the project, the participants are mapped in the same way as before ordinary outpatient consultations. The applications will then be assessed by a defined committee at management level. The committee runs across all clinics and disciplines, and FIU director Gunnar Morken is the contact person.
To facilitate the monitoring of drug studies, an office has been rented in Miljøbygget (Teknobyen), Prof. Brochs gate 2. The office is located in shared premises with the Center for Health Services Research, 2nd floor. The office is separated from the hospital’s central building stock. Read more about this in the hospital’s procedure for monitoring visits.
Arrangements for monitoring drug studies during the pandemic period
Feel free to contact LMI’s Hege Edvardsen (hege.edvardsen@lmi.no) if you have information that may be relevant in this case.