Clinical Trials Office
The Clinical Trials Office is the department within IKNL that offers professional support to researchers, physicians, and medical specialists who are involved in clinical trials for cancer patients. The Clinical Trials Office has a nationwide network, is fully independent, and operates on a non-profit basis. Quality is of paramount importance.
Our Clinical Trials Office has a staff of 100. The Office offers support in the form of central data management, local data management, monitoring, project management clinical trials, and quality-of-life questionnaires. These services can be purchased separately or as an ‘all-in’ package. The Clinical Trials Office only offers these services within the Netherlands and/or when the Netherlands participates in international trials conducted by foreign agencies, or in international multicentre studies.
In providing these services, the Clinical Trials Office acts as an external, independent party. The activities involved are carried out in the participating centres and/or at one of IKNL’s facilities.
The services are subsidised by various funding bodies, such as the Dutch Cancer Society.
Clinical Trials Office services
The Clinical Trials Office provides support through central data management, local data management, monitoring, and project management clinical trials. A brief explanation of the various services is given below.
Central data management, including:
- Translating clinical trial protocols into CRFs (case report forms), and designing databases.
- Creating an online registration system and/or a randomisation program (if required, registration and randomisation can be carried out by the Clinical Trials Office secretariat).
- Support with the SAE (serious adverse event) process.
- Collecting, processing, and verifying data (data flow, cleaning, and queries).
Local data management, including:
- Verifying informed consent and selection criteria.
- Collecting and coding the requisite data, and incorporating them into the CRF, using registered data managers, in accordance with the applicable legislation and regulations.
- Identifying any discrepancies/irregularities and take action in relation to key parties involved.
- Verifying that the rights and wellbeing of clinical trials patients are protected.
- Verifying that the reported research data is complete and verifiable in source documents.
- Verifying that the study is conducted in accordance with protocol/amendment (or amendments), GCP (Good Clinical Practice), the Declaration of Helsinki, and other relevant legal requirements.
- Monitoring the TMF/ISF (Trial Master File/Investigator Site File), pharmacy, laboratory, and biobanking.
Project management clinical trials, including:
- Consultation and support with the development of the clinical trial protocol and other essential documents.
- Managing the clinical trial and monitoring its progress.
- Supervising the submission of documentation to the central METC (Medical Ethics Review Committee) and to the competent authority.
- Supervising the submission of documentation to the participating centres’ boards of directors.
Safeguarding quality and ensuring compliance with legislation and regulations
IKNL is certified to NEN 7510 and ISO 27001. IKNL is also compliant with the standards laid down in NEN 7512 and NEN 7513.
All central and local data managers, monitors, and project managers clinical trials are BROK-certified (Basic course on Regulations and Organisation for clinical investigators) and/or GCP-certified (Good Clinical Practice). In addition, all data managers are registered in the Dutch Association of Oncology Data Managers’ (NVvOD) quality register.
The staff of IKNL’s Clinical Trials Office operate in accordance with the applicable legislation and regulations. These include the GDPR (General Data Protection Regulation), the WMO (Medical Research (Human Subjects) Act), the WGBO (Medical Treatment Contracts Act), two European directives (Directive 2001/20/EC and Directive 2005/28/EC), and an EU Regulation (Regulation EU No 536/2014).
IKNL’s Clinical Trials Office has concluded an agreement with all hospitals and radiotherapy centres in the Netherlands, plus a few research groups. One of the stipulations of this agreement is that the support provided will be in accordance with these quality requirements, items of legislation, and regulations.