Informing reviewing committees & parties Research Roadmap Amsterdam UMC

Informing Reviewing Committees & parties involved

If the study is terminated as provided in the protocol, the end date (in most cases, the date on which the last subject underwent the last action of the study) should be reported to the reviewing committee (or committees). The procedure and period in which this must be done can differ according to the type of study.

Termination of a trial involving medicinal products

Trials with medicinal product subject to the Dutch WMO Act (under previous legislation)

Send within 90 days:

The Final report form to the MREC Amsterdam UMC or the CCMO ‘Study termination form’ form if the CCMO has been the reviewing assessment committee.
The EudraCT end-of-trial form to the MREC and the competent authority (CCMO or VWS), stating the study’s NL number.

Within one year after the end of the study (worldwide) you must submit a summary of the study results of to the review committee (MREC or CCMO). This can be a scientific publication or upload a summary of a final report in ToetsingOnline.

Trials subject to the CTR

Within the CTR, the sponsor should enter the end of the study in CTIS within 15 days from the end of the clinical trial in relation to that MSc. The enddate of the clinical trial in all MSc in the EU as well as in all third countries should be reported in CTIS within 15 days from the end of the CT in the last of the MSc as well as in the last of the MSc and third countries in which the CT has been conducted. See the site of the CCMO or CMC for more information about reporting the end of your study.

Termination of a trial involving medical devices

MDR Article 62/74 studies

Send within 15 days:

The Final report form to the MREC Amsterdam UMC or the CCMO ‘Study termination form’ form if the CCMO has been the reviewing assessment committee.
Notify the CCMO as competent authority for clinical investigations with medical devices at devices@ccmo.nl

Note: In addition, the international end date (i.e. global end date) must be reported separately to the MREC at metc@amsterdamumc.nl and, if applicable, also to the CCMO as competent authority at devices@ccmo.nl.

MDR Article 82 or studies with a positive decision prior to May 26, 2021

Send within 56 days:

The Final report form to the MREC Amsterdam UMC or the CCMO ‘Study termination form’ form if the CCMO has been the reviewing assessment committee.

Termination of other studies subject to the Medical Research (Human Subjects) Act (WMO)

Within 56 days (8 weeks) after the end of the study, the review committee must be informed about the end date of the study, as defined in the protocol. This is usually the date on which the last studyprocedure was taken on the last subject. This concerns the end date in the Netherlands. In the case of multinational research, the start and end date of the research part outside the Netherlands may be different

Send the Final report form to the MREC Amsterdam UMC.

Premature termination:

Premature termination means that the study was terminated earlier than foreseen in the study protocol.

Studies subject to the Medical Research (Human Subjects) Act (WMO)

Premature termination of the investigation must be reported within 15 calendar days, stating the reason, to the portfolio holder of the Executive Board the Director of Medical Affairs and the rewiew committee. In the event of an early termination for safety reasons also inform Quality Assurance Clinical Research

Medical device MDR Article 62/74 studies

Article 77 of the MDR applies to Article 62/74 investigations. The review committee must be informed by the sponsor within 15 days after the premature termination of the study in the Netherlands. When there is an international investigation, the end of the investigation applies in all EU member states.

In the event of an early termination for safety reasons, the sponsor must notify within 24 hours:

all EU Member States in which the clinical investigation is carried out,
The Final report form to the MREC Amsterdam UMC or the CCMO ‘Study termination form’ form if the CCMO has been the reviewing assessment committee.
CCMO as competent authority for clinical investigations with medical devices at devices@ccmo.nl.

In the event of an early termination of clinical investigations in the Netherlands for reasons other than safety, the sponsor must notify within 15 calendar days:

The Final report form to the MREC Amsterdam UMC or the CCMO ‘Study termination form’ form if the CCMO has been the reviewing assessment committee.
CCMO as competent authority for clinical investigations with medical devices at devices@ccmo.nl.

Medical device MDR Article 82 or studies with a positive decision prior to May 26, 2021

The sponsor is required to report the early termination to the review committee concerned (accredited MREC or CCMO) within 15 calendar days.

Trials with medicinal product subject to the Dutch WMO Act (under previous legislation)

The Final report form to the MREC Amsterdam UMC or the CCMO ‘Study termination form’ form if the CCMO has been the reviewing assessment committee within 15 calender days after the decision.

Trials subject to the CTR

Early termination of a clinical trial for reasons not affecting the benefit-risk balance should be reported in CTIS within 15 days. Early termination for reasons of subject safety should be reported in CTIS without undue delay but not later than in 15 days.

In both cases the report shall include the reasons for such action and specify follow-up measures for the subjects.

Who else to inform?

Thereafter, inform all other parties who have been involved in the study, including:

The entity that performed the monitoring. Aspects to be examined/confirmed during this visit include whether all adverse events have been reported, whether all signed informed consent forms are present and whether the source documentation is present for all included patients. A monitoring close out visit must be performed if at least one subject has been included in the study. If no subjects have been included, no monitoring will take place. Termination of the study must be reported, and the study documentation must be archived properly.
Pharmacy: For a drug trial, any remaining or returned investigational medicinal products must be inventoried and registered in the log book that has been maintained throughout the study (Investigational Product Accountability Log). Depending on the agreements made, any unissued or returned medication must be destroyed or returned to the supplier or pharmacy. Contact the pharmacy in order to follow the correct procedures in this regard.
Adviesmedischehulpmiddelen@amsterdamumc.nl or the purposes of settling the remaining medical devices. In this case as well, any unused packaging must be returned to the supplier or properly destroyed in-house.
The independent expert who has been involved in the study
For multi-centre studies: the participating centres through the local principal investigators
The DSMB, if applicable
If the study is registered in a trial register, this must be updated with the information that the study has been concluded.
All other local facilitating departments (e.g. lab, radiology)
In addition, contact those responsible for the budget and the financial side of the study (in most cases, the finance officer of the relevant division). For example, verify that all bills have been paid and, if necessary, that subsidies have been received in full.