Informing reviewing committees & parties Research Roadmap Amsterdam UMC

Informing review committee(s) & parties involved

If a study is terminated as defined in the study 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). The procedure and required timeframe may vary depending on the type of study.

Termination of clinical trials involving medicinal products

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 study 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 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

MDR article 62/74.1/74.2 studies

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 within 15 calendar days of the study's completion. 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.

MDR article 82 studies or studies approved before May 26, 2021

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 within 56 calendar days of the study's completion. 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.

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.

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

Premature termination

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

At Amsterdam UMC, standard procedures for reporting premature termination in medical scientific 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 clinical trials' end date. 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.

MDR article 62/74.1/74.2 studies

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 (MREC or CCMO), the competent authority (CCMO), and all EU member states in which the study was conducted within 24 hours.

MDR article 82 studies or studies with a positive decision dated before May 26, 2021

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 monitoring visit is required, but study termination must still be reported and all study documentation must be archived properly;
Pharmacy (for drug trials): 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;
Multi-centre 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;
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.