Functions
- Establish a Work and Activities Plan, including objectives, assigned activities, organization, participating UICs, and the operating rules of the WG. This plan must be approved by the Steering Committee and the General Assembly.
- Plan and oversee activities in line with the project portfolio and ongoing initiatives, leveraging each Unit’s resources for the collective benefit and maximizing efficiency across the entire network.
- Define work procedures relevant to the group’s specific area.
- Provide guidance to the Units on activities related to their field of expertise.
Working Groups
SCReN currently has a total of 8 Working Groups (WGs), which may be revised or modified based on the Platform’s evolving needs and subject to evaluation and approval by the Steering Committee. Each WG is led by a coordinator and a deputy coordinator from different UICs. They are jointly responsible for developing the work plan and procedures, which include objectives, organizational structure, and operational guidelines.
The groups are composed of a variable number of members from different units, depending on the complexity and scope of their assigned tasks. These members contribute their expertise and knowledge to carry out the specific functions of each WG.
All WG activities are designed to leverage the strengths and resources of each Unit for the collective benefit of the entire network, thus maximizing operational efficiency. To ensure coordination and integration across all groups, the Platform Coordination team oversees their activities.
WG1. Research Methodology
This group is responsible for developing and providing expert advice on complex study designs and innovative methodologies in clinical research. Its work includes adaptive trial designs, studies embedded in routine clinical practice, and other advanced approaches.
The group brings together specialists from diverse areas such as regulatory affairs, bioethics, observational research, pharmacoeconomics, early-phase studies, advanced therapies, and pediatric research. Its objective is to ensure high methodological standards and provide transversal support across all areas of the Platform’s activity.
WG2. Internationalization
Although international clinical research has advanced significantly in recent years, expanding its reach remains a major challenge, particularly in the field of independent clinical research.
This working group focuses on promoting the active participation and leadership of Spanish research centers and units in international clinical projects. To achieve this, it collaborates closely with accredited Health Research Institutes (IIS), national research networks, and the Instituto de Salud Carlos III (ISCIII).
WG3. Clinical Research Monitoring and Quality
Clinical research must comply with strict regulations to ensure data quality and adherence to Good Clinical Practice (GCP) guidelines. These standards apply equally to industry-sponsored and independent studies.
This working group plays a key role in supporting investigators by helping them implement and maintain these regulatory requirements throughout the study. It ensures that independent clinical research is conducted under the highest standards of quality, reliability, and ethical compliance.
WG4. Pharmacovigilance
In line with GCP guidelines and current regulations, this working group is responsible for coordinating and managing all aspects related to the safety of research activities carried out within the Platform.
Its functions include overseeing pharmacovigilance procedures, ensuring proper collection, analysis, and reporting of adverse events, and supporting investigators in meeting regulatory safety requirements in all clinical studies.
WG5. Data Management and Statistics
Efficient and accurate clinical data management is critical to ensuring high-quality results and minimizing the time from study design to publication. This process includes the design of the Case Report Form (CRF) and database, data entry, validation, and database lock prior to statistical analysis.
Statisticians play a key role throughout the entire clinical research cycle, contributing from study design and methodological planning to the final analysis and interpretation of results.
WG6. Communication and Public Engagement
This group is responsible for developing a comprehensive communication strategy and implementing actions aimed at bringing science closer to society. Its objectives include promoting public understanding of clinical research, actively involving citizens in study development, and ensuring transparent dissemination of results and educational content.
WG7. Training
This group is responsible for designing and implementing training programs for healthcare professionals in the Clinical Research Units and the Coordination team. The training covers methodological, practical, logistical, ethical, and legal aspects of clinical research, aiming to strengthen the skills and competencies required to conduct high-quality studies.
WG8. Early-Phase Studies (Phase I, Proof-of-Concept Studies)
This group focuses on the implementation and support of early-phase clinical studies, including Phase I and proof-of-concept trials. These studies require highly specialized units with dedicated infrastructure, equipment, and trained personnel. They are especially relevant for research in advanced therapeutic areas such as oncology, vaccines, and gene or cell therapies.