Reporting study progress

  • WMO

During a study, several aspects must be monitored in addition to the study visits of participants. For example, once the study is approved by the review committee (MREC or CCMO), they require regular updates on its progress. They also expect to be notified of any adverse events within the specified timelines, and changes to the study protocol must be submitted as amendments.
Furthermore, the TMF/ISF must be maintained, all collected data must be entered into the (e)CRF, and a monitor will conduct regular visits to ensure compliance with GCP guidelines and the approved study protocol.

Annual progress and safety reports

Progress report

For clinical investigations involving medical devices, IVD performance studies and other research subject to the WMO, annual progress reports must be submitted to the review committee via the Research Portal. Depending on the type of study, the report form may also include safety-related questions. The reporting period is based on the date of approval of the study, with the first report due no later than 12 months after approval and continuing annually until the study's completion.
Consult the CCMO website for guidance on using the Research Portal.

Progress reports do not need to be submitted to the competent authority (CCMO or VWS).

For clinical trials involving medicinal products, an annual progress report is not required. However, consult the CCMO website for an overview of other mandatory notifications and their corresponding timelines.

For more information on local procedures, consult the MREC website.

Safety report

For clinical trials involving medicinal products an Annual Safety Report (ASR) on the investigational medicinal product must be submitted via CTIS each year. For further details, consult the CCMO website or the CMC website for local procedures.

IB / SPC evaluation

For clinical trials involving medicinal products, the Investigator’s Brochure (IB) must be reviewed at least annually to assess any revised and/or additional safety information (clinical or pre-clinical) or other relevant updates. Depending on the investigational product's development stage and the availability of new information, more frequent revisions may be necessary. If new information is of significant importance, it must be immediately provided to the review committee (via CTIS), the principal investigators at participating sites, and the study participants, before being incorporated into a revised IB and subject information letter.

For studies involving a registered medicinal product, an annual review must determine whether any changes to the Summary of Product Characteristics (SPC) require updates to the subject information letter.

If new data are included in the IB or SPC, the updated document must be submitted to the review committee as a substantial amendment. 

Protocol deviations / Serious breaches

A protocol deviation occurs when procedures or actions differ from those outlined in the study protocol. In Amsterdam UMC, the GCT SOP 02 reporting deviations and escalations in research involving human subjects describes the procedures to manage such deviations. A flowchart is available to determine how, when and to whom deviations should be reported.

Non-important (minor) deviations
Minor deviations are recorded in the (electronic) Case Report Form (eCRF) or on a study specific deviation log. These include administrative deviations that do not directly impact the safety of participants, such as a study visit or questionnaire completed 'out of window' or a participant unintentionally skipping a study procedure.

Important (major) deviations / Serious breaches
Major devations or serious breaches (in clinical trials involving medicinal products) are deviations from the study protocol or applicable laws and regulations that significantly impact the safety and/or well-being of participants or the integrity of collected study data. The impact assessment depends on various factors and is conducted by the reporter (the principal investigator in case of clinical trials involving medicinal products). Each deviation is evaluated individually based on its context.
Major deviations and/or serious breaches must be reported as soon as possible upon discovery, using the appropriate forms: GCT T38a Important deviation / serious breach form or GCT T38b Important deviation form – participating site .
Additionally, serious breaches must be reported to Quality Assurance Research and via CTIS within 7 days by the study-specific clinical trial administrator.

Note: Adverse events in medical scientific research may also meet the criteria for (near) incidents or calamities within Amsterdam UMC. Reporting such incidents is part of the institution's integral quality system. Incidents can be reported via the Safety Management System: I-Task. For definitions and instructions, refer to the manual in K2. 

Study suspension

If a study is (temporarily) suspended due to suspected safety reasons, the following actions must be taken:

  1. Notify the review committee and, if applicable, the competent authority of the reason for the temporary and unexpected suspension of participant inclusion and/or the study. This notification must be made via e-mail (for MREC Amsterdam UMC: metc@amsterdamumc.nl) and

    • For clinical trials involving medicinal products: within 15 days via CTIS
    • For other research subject to the WMO/MDR/IVDR: immediately/within 24 hours via the Research Portal
  2. Inform the department head, Quality Assurance Research, the portfolio holder of the Executive Board and the Director of Medical Affairs;
  3. Block the study's randomisation system (if applicable);
  4. For multi-centre research: notify al participating centres and researchers that inclusion has been suspended;
  5. Before resuming the study (if applicable): submit an amendment to the review committee if any study documents have been revised. The study/inclusion cannot be resumed until the review committee has approved the amendment.

If the suspension of the study is for reasons other than the safety of participants, different timeframes for reporting apply, depending on the type of study.

In Amsterdam UMC, the procedure for study suspension is outlined in GCT SOP 02 reporting deviations and escalations in research involving human subjects.

(Premature) termination of the study

A study is considered terminated when the last participant underwent the last study procedure (i.e. the end date). If a study ends earlier than foreseen in the study protocol, it is classified as a premature termination. Several entities must be informed of the study's (premature) termination; refer to Informing review committee(s) & parties involved for further details.