Research Roadmap

If a study is terminated as defined in the research protocol, the end date (in most cases the date when the last participant underwent the last study procedure) must be reported to the review committee(s) and other parties involved. The procedure and timelines depend on the type of study.

Termination of clinical trials involving medicinal products

The CTR defines the end of a clinical trial as the last visit of the last participant in de last member state concerned (MSc), or a later time point specified in the research protocol.

According to article 37 of the CTR, the end date of the clinical trial in a MSc must be reported in CTIS within 15 days of the trial's completion in that MSc.
Additionally, the global end date of the clinical trial (across all MScs in the EU and all third countries) must be reported in CTIS within 15 days of the trial's completion in the last MSc and the last third country where the trial was conducted.

For more information, consult the CMC website.

Termination of investigations involving medical devices

The sponsor must report the end of the study to the review committee (MREC or CCMO) and the competent authority (CCMO) via the Research Portal.

• For MDR article 62/74.1/74.2 studies: within 15 calendar days of the study's completion;
• For MDR article 82 studies or studies approved before May 26, 2021: within 56 calendar days of the study's completion.

These timelines apply to the end date in the Netherlands, the end date across all EU member states, and the global end date of the study.

For more information, consult the CCMO website or the MREC website for local procedures.

Termination of other studies subject to the WMO

The sponsor must report the end of the study to the review committee (MREC or CCMO) via the Research Portal within 56 calendar days of the study's completion. This concerns the end date in the Netherlands. For multinational studies, the (start and) end date of the study outside the Netherlands may differ.

Consult the CCMO website for more information, or the MREC website for local procedures.

Premature termination

Premature termination occurs when a study ends earlier than foreseen in the research protocol.

At Amsterdam UMC, standard procedures for reporting premature termination in research are outlined in GCT SOP 02 Reporting deviations & escalations in research involving human subjects.

Clinical trials involving medicinal products

Premature termination of the clinical trial for reasons that do not affect the risk-benefit ratio must be reported in CTIS within 15 days of the end date of the trial.
If premature termination is due to safety or quality concerns, it should be reported in CTIS without undue delay, but no later than 15 days.
The report should state the reasons for the decision and the follow-up measures for the participants.

Clinical investigations involving medical devices
(All MDR studies and studies with a positive decision before May 26, 2021)

The sponsor must report the premature termination to the review committee (MREC or CCMO) and the competent authority (CCMO) via the Research Portal within 15 calendar days of the end date of the study. This deadline applies to the end date in the Netherlands, the end date across all EU member states, and the global end date of the study.

If premature termination is due to safety concerns, the sponsor must notify the review committee, the competent authority, and all EU member states in which the study was conducted within 24 hours.

Other studies subject to the WMO

Premature termination of the study must be reported to the review committee (MREC or CCMO) via the Research Portal within 15 calendar days of the end date of the study.
If premature termination is due to safety concerns, also inform the department head, Quality Assurance Clinical Research, the portfolio holder of the Executive Board, and the Director of Medical Affairs.

Who else to inform?

After reporting the study termination, notify all other relevant parties involved in the study, including:

• Monitoring entity: a close-out visit must be performed if at least one participant was enrolled in the study. Ensure that all adverse events have been reported, informed consent forms are present, and source documentation is complete for all participants. If no participants were enrolled, no close-out visit is required, but study termination must still be reported and all study documentation must be archived properly;
• Pharmacy: any remaining or returned investigational medicinal products must be inventoried and recorded in the Investigational Product Accountability Log. Following the agreements made, any unissued or returned medicinal product must be either destroyed or returned to the supplier or pharmacy. Contact the pharmacy to ensure compliance with the correct process;
• adviesmedischehulpmiddelen@amsterdamumc.nl to settle any remaining medical devices. Unused packaging should either be returned to the supplier or properly destroyed in-house;
• The independent expert involved in the study;
• Multicenter studies: notify all participating centres via their local principal investigators;
• The Data and Safety Monitoring Board (DSMB), if applicable;
• Ensure that the applicable trial registry is updated to reflect the study's completion;
• In relation to local approval of the Executive Board (Lokale Uitvoerbaarheid), ensure that the study is closed in local registries such as Research Manager and/or Epic. Consult the website of the MREC office for more information on what and how to report for Research Manager;
• All other local facilitating departments, such as the laboratory and radiology;
• Finance officer of the relevant division: for example to verify that all invoices have been paid and any subsidies or funding have been received in full.