Trial start-up

For each new trial proposal the Principal Investigator fills out a trial proposal form. A feasibility meeting will take place to look at the possibilities of conducting this study and determine the timelines.

HOVON uses its own templates to ensure uniformity within HOVON trials, which makes setting up a trial and rolling it out efficient. All start up documents (like the trial proposal form, HOVON protocol template and ICF template) can be found after log in in trial start-up document section (you need to log in to find this information).

HOVON will submit the general trial documents to the authorities. At the trial section you can view per trial the expected vs. real timelines for the different phases (development / submission / activation).

As soon as we receive approval from both the Competent Authority and Ethical Committee, an Investigator Trial File (ITF) is set up and send out to the sites.

ECTR (European Clinical Trial Regulation)

As a sponsor of clinical trials, HOVON is committed to conducting research of the highest quality to advance medical knowledge and improve patient care. The European Clinical Trial Regulation (ECTR) has brought significant changes to the regulatory landscape, and we want to ensure that you are well-informed about its implications for our collaborative efforts.

The ECTR, which came into effect on the 26th of May 2021, replaces the previous Clinical Trials Directive and introduces a harmonized framework for conducting clinical trials within the European Union (EU) member states. Its primary objectives are to enhance patient safety, improve the reliability of trial data, and streamline the authorization and oversight processes.

As investigators working with HOVON, you play a pivotal role in the successful execution of our clinical trials. Therefore, we want to provide you with a clear understanding of the key elements of the ECTR and how they impact your role.

One of the most significant changes introduced by the ECTR is the centralized portal and database known as the EU Clinical Trials Information System (CTIS). This system serves as a centralized platform for submitting trial applications and managing trial data. As investigators, you will be required to submit applications and updates through the CTIS, ensuring a streamlined and efficient process for regulatory authorities and ethics committees.

The ECTR also emphasizes the importance of transparency in clinical research. As a sponsor, HOVON is responsible for ensuring that information about our trials is readily accessible to the public. This includes providing detailed summaries of trial protocols and results through the CTIS and public databases. We encourage you to collaborate with us in fulfilling these transparency requirements, as it promotes trust, scientific integrity, and the dissemination of knowledge.

Another significant aspect of the ECTR is the establishment of clear timelines for the review and decision-making processes by competent authorities and ethics committees. This aims to expedite the approval process for clinical trials, allowing us to initiate studies more efficiently and minimize unnecessary delays. As investigators, your timely submission of documentation and responses to requests for information will be crucial in meeting these timelines.

Furthermore, the ECTR introduces enhanced standards for data protection and privacy. We must ensure that personal data collected during clinical trials is processed in compliance with applicable data protection regulations, such as the General Data Protection Regulation (GDPR). Protecting the rights and privacy of trial participants is of utmost importance, and we rely on your adherence to good clinical practice (GCP) guidelines to achieve this goal.

As participating investigators, we value your expertise and dedication to conducting clinical research. We recognize that the ECTR brings new challenges and responsibilities, but it also presents opportunities for greater collaboration, standardization, and efficiency in our trials. HOVON is committed to supporting you throughout this transition to ensure compliance with the ECTR requirements.

Together, we can navigate the regulatory landscape, uphold the ethical standards, and contribute to the development of safe and effective treatments for patients.

If you have any questions or need further clarification on the ECTR or any related matters, please do not hesitate to reach out to our dedicated team at HOVON.
HOVONECTR@erasmusmc.nl

HOVON Guideline CTIS trial submission

Site start-up

As soon as the trial is approved by the authorities, the participating sites that were selected to participate receive the Investigator Trial File (ITF) together with a Site Document Checklist that indicates which (filled out / signed) forms we need back to be able to activate your site. These are also available (after log in) at the trial section > Downloads.

When we receive all required documents (like a signed signature page of the protocol and Clinical Trial Agreement), we will start up the process of the IMP delivery to your site (if applicable). If you (or your pharmacy department) indicates that the medication has been received in good order and released, we shall activate your site in our system (both the Trial Management System and in ALEA (if applicable)). We also send out messages to the local trial team with information that the activation took place.

Once you have received the message that your site has been activated, you can start screening and enrolling patients in the trial.

Insurance

The HOVON takes out insurance for every trial, to cover claims arising from participation in a trial, and which are not covered by the general liability of the hospitals. If you participate in a trial within HOVON, you therefore need not take out this insurance yourself.

For more information about insurance, we refer you to the CCMO website.