Information regarding processing times for Clinical Trial and Substantial Amendment Applications

The Norwegian Medicines Agency is currently experiencing reduced staffing levels. This is due to the measures implemented by the government as a result of the covid-19 outbreak in Norway. Therefore, longer processing times for applications will need to be expected for both Clinical Trial and Substantial Amendment Applications (is not applicable for covid-19 applications). 

Information regarding changes to Clinical Trials as a result of the covid-19 outbreak

The below described changes are applicable to further notice is given.

Due to given measures implemented throughout all sectors in Norway including the Health Service, it is likely that many clinical trials will be affected and may not be able to be conducted as planned.

Firstly, NoMA would like to encourage all clinical trial investigators and their teams to take appropriate precautions regarding infection control. Secondly, we request that sponsors and their affected research units make the necessary priorities and measures as early as possible, so that the changes can be implemented in the safest possible way.

NoMA defines all changes that must be made in clinical trials as a result of covid-19 readiness as safety measures. This means that changes and safety measures can be implemented before they are sent for approval to NoMA. Once your team has implemented the change(s), please send an email to inform us. The submission of a substantial amendment application with any changes to e.g. the protocol, EudraCT application form, etc. can be submitted to NoMA at a later date.

Information regarding submission of applications and questions relating to Clinical Trials covid-19

We request that all submissions relating to covid-19 are clearly marked, preferably in the subject heading of your e-mail. All covid-19 submissions will be prioritised by NoMA.

Information relating to the implementing and conducting of clinical trials during the covid-19 outbreak can be found below, please check back regularly for updates. 

We will also try to answer all you questions sent by e-mail to klut@legemiddelverket.no. Please ensure that any questions relating to covid-19 are clearly marked covid-19 in the subject heading.

Questions and Answers relating to covid-19 and Clinical Trials

Is it possible to send study drugs to a patient’s home, for ongoing clinical trials?

Yes, the Norwegian Medicines Agency (NoMA) considers sending study drugs to the patient’s home acceptable under the current measures implemented by the government. 

Study drugs must be acquired using standard routines by the Principal Investigator or by the Study Physician who has been delegated this task. 

In the event that study drugs are sent directly to a patient, the following must be adhered to:
  • The study drugs must be delivered directly to the patient, at their place of residence. 
  • The study drugs cannot be sent by post or delivery package, nor put in the patient’s letterbox. 
  • Direct shipping of study drugs from the Sponsor to the patients address is not acceptable.
The following amendments must be made:
1) A general description of procedures regarding the delivery of study drugs are to be described in a supplement or in an appendix to the protocol
2) All individual deliveries of the study drug must be documented.

Will the current situation affect processing times for Clinical Trial and Substantial Amendment Applications? What if I need to send in an application as a result of the covid-19 outbreak?

NoMA is prioritising all clinical trial and substantial amendment applications that arise as a result of the covid-19 outbreak. We request that all submissions relating to covid-19 are clearly marked, preferably in the subject heading of your e-mail. All covid-19 submissions will be prioritised by NoMA.

Please note however, that NoMA is experiencing reduced staffing levels at present. Therefore, longer processing times for other types of applications will need to be expected.

Does NoMA have any plans to fast track the review process for clinical trial applications with covid-19 indication and are considered to be of relevant interest in Norway?

Yes, fast track processing times will be applicable for all clinical trial applications where the indication of the study is covid-19 prevention or treatment.

How does NoMA define changes made to ongoing clinical trials as a result of the covid-19 outbreak? Should we submit a substantial amendment application to NoMA?

NoMA defines all changes that must be made in clinical trials as a result of covid-19 readiness, as safety measures. This means that changes and safety measures can be implemented by the sponsor before they are sent for approval to NoMA. 

Once your team has implemented the change(s), please send an email to inform us. The submission of a substantial amendment application, together with any changes to e.g. the protocol, EudraCT application form, etc. will need be submitted to NoMA at a later date.

The sponsor must ensure that a risk assessment is carried out, and any changes that are introduced are well documented.

Is it possible to invite clinical trial participant to attend their appointments at different site? Can another physician/investigator examine the participant for study-related examinations or tests?

NoMA considers this to be necessary change for ongoing clinical trials, given the current measures implemented by the government.

If the changes relating to site or personnel are considered acceptable by all parties involved i.e. the principal investigator, the clinical trial team as well as the patient/participant, then it is acceptable to do so.

All extraordinary appointments must be documented at the original site and the temporary site, as well as in the patient’s records etc. An agreement must be made regarding how the transfer of study data will be communicated between the two (or more) sites.

Any significant medical decisions made during the appointment must be communicated immediately to the principal investigator at the site to which the patient belongs.

For further information, please see our answer in this Q&A regarding the submission of substantial amendments for clinical trials. 

Can we implement the use of telemedicine for ongoing clinical trials during this period?

NoMA considers this to be necessary change for ongoing clinical trials, given the current measures implemented by the government.

The sponsor must decide whether this will be medically justifiable with regard to further treatment of the patients. 

For further information, please see our answer in this Q&A regarding clinical trial participants attending other sites, as well as our answer regarding the submission of substantial amendments for clinical trials. 

Can remote/electronic information or forms for recruitment, patient information or patient consent be used during this period? 

Changes in procedures regarding the use of remote/electronic information or forms for recruitment, patient information, or patient consent will need to be reviewed by an Ethics Committee. 

We recommend that you get in touch with the Ethics Committee for Medical and Health Research (REK) in your region, for further advice regarding the application process. 

Is it possible to change the method for study-specific examinations during this period? Can a study nurse, for example, carry out examinations at the patient's home, or by other methods without physically visiting the patient?

NoMA considers this to be necessary change for ongoing clinical trials, given the current measures implemented by the government

The sponsor will need to decide whether this will be medically justifiable with regard to further treatment of the patients. Personnel carrying out study-related tasks must be trained in the examinations being carried out. This training must be documented. Changes to the procedures must also be documented. 

For further information, please see our answer in this Q&A regarding clinical trial participants invited to attend a different site/attended by another investigator for study-related tests or examinations.

Is it possible to perform Source Data Verification (SDV) remotely?

NoMA does not consider remote SDV acceptable as it jeopardizes the rights of the clinical trial participants. Sponsors can implement centralised monitoring based on data documented in electronic Case Report Forms (eCRFs) however, this does not replace SDV. 

The sponsor must document all changes that have been introduced, and the time period. SDV should resume once the situation normalises.

Are the any covid-19 studies that are currently underway and can be recommended by the NoMA?

Yes, there is a protocol called INSERM. 

NoMA recommends combining studies of covid-19 in the EU, and if possible, to avoid any individual studies where it can be difficult to use the data later on. In addition, it is likely to be easier to obtain medicines for larger/multi-centre studies. 

Please contact NoMA, the French Medicines Agency or the following persons regarding the INSERM-protocol: 

Contacts for the INSERM-protocol
Professor Yazdan YAZDANPANAH, yazdan.yazdanpanah@inserm.fr 
Professor Herman GOOSENS, Herman.Goossens@uza.be 

Our colleague at the French Medicines Agency
Nathalie MORGENSZTEJN, Nathalie.MORGENSZTEJN@ansm.sante.fr 






Oppdatert: 19.03.2020

Publisert: 16.03.2020

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