Description
The Clinical Research Unit (CRU) of ISABIAL is a support platform for clinical research, whose main function is to provide assistance to researchers in the development of projects, both in independent or non‑commercially sponsored clinical research and in commercially sponsored clinical trials. The unit offers scientific and administrative advice, and also supports regulatory and clinical management aspects, as well as the monitoring and pharmacovigilance of independent clinical trials.
Since 2024, the Clinical Research Unit (CRU) has been part of the Clinical Research and Clinical Trials Units Platform SCReN (Spanish Clinical Research Network) of the Carlos III Health Institute (ISCIII).
SCReN is a cooperative functional network that brings together Clinical Research Units (CRUs) from 34 different centres across 14 autonomous communities. Its overall objective is to facilitate the conduct of high‑quality, excellent clinical research by providing appropriate support to scientifically relevant proposals, ensuring their proper development, dissemination, and final translation into the Health System.
The Clinical Research Unit (CRU) specializes in the planning and development of clinical studies, providing this service to ISABIAL researchers, Contract Research Organizations (CROs), and sponsors at all stages of a clinical study. It has a team composed of Clinical Trial Managers (CTMs) or Project Managers (PMs), Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), Study Coordinators (SCs), and data entry specialists (DEs).
Services
The Clinical Research Unit (CRU) provides services to researchers who wish to carry out clinical research studies in their role as sponsors, ensuring compliance with legislation and Good Clinical Practice (GCP) guidelines.
These services are primarily tailored to clinical trials involving medicinal products, but the CRU adapts them to all types of research in accordance with the corresponding agencies and registries, including medical device investigations, observational studies, and research projects.
Services offered:
Project Manager//CTM
- Methodological advice on the design of research protocols for observational, experimental, and quasi‑experimental studies
- Statistical advice and analysis
- Design, development, and validation of CRFs
- Digitization of CRFs
- Drafting or adaptation of patient information sheets and informed consent forms
Project Manager//CTM
- Preparation and submission of general documentation and trial applications to Regulatory Agencies
- Payment of fees (EC/IRB and/or AEMPS)
- Clinical trial registration and registry maintenance
- Clarifications and amendments for regulatory agencies and/or ethics committees
- Preparation of the monitoring plan
- Collection of signatures and submission to the sponsor
- Request for civil liability insurance policy (selection and contracting, policy processing)
- Management of contracts with participating centers
Monitor
- Preparation and maintenance of the sponsor and investigator files
- Conducting on‑site and/or remote monitoring visits at each participating center
- Preparation of the monitoring visit report and follow‑up of outstanding issues
- Resolution of issues at the study site
- Maintenance of the sponsor’s trial master file
Project Manager // Clinical Trial Manager
- Study, material, medication, and biological sample management
- Notification of study/site initiation to AEMPS and EC/IRB
- Preparation of documentation for amendments (protocol, addition of sites, PI changes, etc.) and submission to EC/IRB and AEMPS
- Preparation of annual reports and submission to AEMPS and EC/IRB
- Review of monitoring visit reports
- Management of biological samples
- Financial management of the clinical trial or project
Monitor (CRA)
- Conducting on‑site and/or remote monitoring visits at each participating center
- Preparation of the monitoring visit report and follow-up of outstanding issues pending resolution
- Resolution of issues at the study site
PM // CTM
- Notification of study/site closure to EC/IRB and AEMPS
- Support and submission of the Final Results Report
- Update of study/site closure status in the relevant registries
- Supervision and preparation of the final study report
Monitor (CRA)
- Resolution of queries and database lock
- Conduct of the study close-out visit and preparation of the close-out visit report
- Close-out visits
Pharmacovigilance
- Training related to safety management and review of the protocol safety section
- Update of the available documentation on the reference safety information of the investigational medicinal products during the trial conduct
- Training for investigators and study personnel on pharmacovigilance
- Identification, quantification, assessment and prevention of risks associated with the study treatment
- Management of serious adverse events (SAEs)
- Notification to AEMPS of suspected Serious and Unexpected Adverse Reactions (SUSARs) (EudraVigilance)
- Preparation, approval and submission to the authorities of the annual clinical trial safety reports (DSUR)
- Preparation, approval and submission to the authorities of the annual clinical trial safety report
Study Coordinator
- Serve as a liaison between the research team, the involved services and their respective research teams, and the monitors and sponsors
- Active search for study participants, scheduling of visits and procedures in accordance with clinical study protocols, and follow‑up and support of participants throughout the entire study
- Dispensing, collection and accountability of investigational treatments
- Preparation for monitoring visits, audits and inspections, and support during their conduct
- Management of study‑provided materials, files, equipment, devices and laboratory kits, as well as handling of biological samples
- Financial management of clinical studies: review of invoices and patient‑related expenses
- Ensure compliance with the implemented quality programs, as well as with SOPs, GCP and applicable local clinical trial legislation
- Assistance to the monitor during monitoring visits
- Attend to the monitor during monitoring, initiation, close‑out and pre‑selection visits, as well as whenever required
Data Entry
- Collection of source documents
- Timely data entry in the CRFs, in coordination between the Phase I Unit and the Phase I coordinators
- Resolution of queries and follow‑up of AEs
- Notification of SAEs with in 24 hours
- Filing of study documentation
- Assistance to the monitor during monitoring visits
- Attend to the monitor during monitoring, initiation, close‑out and pre‑selection visits, as well as whenever required