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

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

Note: Within the CTR, the sponsor should enter the end of the study in CTIS within 15 days. See the site of the CCMO or CMC for more information about reporting the end of your study.

Send within 90 days:

  1. The ‘final report’ form to the AMC MERC/‘termination form’ to the VUmc MERC or the CCMO ‘Study termination form’ form if the CCMO has been the reviewing assessment committee.
  2. The EudraCT end-of-trial form to the MERC and the competent authority (CCMO or VWS), stating the study’s NL number.

Termination of a device trial

    Send within 56 days:

    1. The ‘final report’ form to the AMC MERC/‘termination form’ to the VUmc MERC
    2. Notify the CCMO at devices@ccmo.nl

    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 AMC MERC/ termination form to the VUmc MERC.

    Notify also:

    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.

    Medical device

    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 end of the study in the Netherlands. When there is an international investigation, the end of the investigation applies in all EU member states.

    National legislation applies to Article 82 investigations. The reviewing committee must be informed by the sponsor within 56 days after the end of the study in the Netherlands.

    Medicinal product

    Send the documentation appropriate to the study, as described above, to the reviewing committees (research involving medicinal products, also to the competent authority) within 15 calendar days after the decision.

      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.