Reports after approval
with an approval comes obligations under the law
Duties of the primary investigator
The regional committee, that has approved the initiation of the health research project, shall supervise the approved project. Therefore, an approval obliges the primary investigator to make reports and notifications to the committee.
What to do
- Annual safety report
Yearly throughout the trial period a list of all presumed serious unexpected adverse reactions that have occurred during the trial period and information on the safety of the trial subjects shall be send to the committee.
It is important that the report states the time period for which it is valid.
- Adverse reactions and events
The committe shall immediately be informed if there is any assumption of serious unexpected adverse reactions as a consequence of the project during the implementation.
Both reports must by submitted by e-mail: komite@rsyd.dk
When to report side effects (adverse reactions) >>
- Termination of health research projects
No later than 90 days after the termination of an approved health research project the committee must be informed of the termination.
We refer to The Committe Act (section 28-31) here:
We refer to The Committe Act (section 28: Supervision) here: https://en.nvk.dk/rules-and-guidelines/act-on-research-ethics-review-of-health-research-projects
(1) The regional committee that has approved the carrying out of a research project shall supervise that an approved health research project which does not involve clinical trial of medicines, is carried out in accordance with this act. If the approval has been given by the national committee, supervision is taken care of by the regional committee in the area where the investigator is active unless because of the complexity of the project the regional committee in question requests the national committee to supervise a given project. Supervision of approved health research projects that involve clinical trial of medicines is taken care of by the Medicines Agency according the medicines act.
(2) The supervising committee may follow the course of a research project and demand that the final research report or publication is sent to the committee.
(3) As part of its supervision of a project that does not involve clinical trial of medicines covered by the medicines act, the supervising committee may require that the project is amended or is temporarily suspended, and in special cases the committee may prohibit a project. These powers also cover notifiable research projects that have been commenced without due permission.
(4) The Minister for the Interior and Health may lay down further rules on the supervision by and the powers of the committees according to (1) to (3) above
We refer to The Committe Act (section 30: Obligation to notify adverse reactions and adverse events) here: https://en.nvk.dk/rules-and-guidelines/act-on-research-ethics-review-of-health-research-projects
(1) The sponsor or the investigator shall immediately inform the supervising committee if during the implementation of a health research project there is any assumption of serious unexpected adverse reactions as a consequence of the project. Unless the research project concerns clinical trial of medicines covered by the supervision of the Medicines Agency according to the medicines act, the notification obligation furthermore covers serious adverse events. When serious adverse events are reported, the supervising committee may require any information from the investigator that the committee finds is relevant for its supervision.
(2) Once a year throughout the trial period the sponsor or the investigator shall send to the supervising committee a list of all presumed serious unexpected adverse reactions that have occurred during the trial period and provide information on the safety of the trial subjects. Unless the research project concerns clinical trial of medicines covered by the supervision of the Medicines Agency according to the Medicines Act, the notification obligation furthermore covers serious adverse events.
We refer to The Committe Act (section 31: Notification on the termination of health research projects) here: https://en.nvk.dk/rules-and-guidelines/act-on-research-ethics-review-of-health-research-projects
(1) No later than 90 days after the termination of a notifiable health research project the investigator and the sponsor shall jointly inform the supervising committee that the project has been terminated.
(2) If a research project is discontinued before its planned termination, the investigator and the sponsor shall jointly inform the supervising committee about the project’s discontinuation no later than 15 days following the decision to discontinue the project. The reasons for discontinuation of the project must be stated. If necessary the supervising committee may require that the investigator and the sponsor submit an explanatory report.