Services and fees

The CTU provides the following services: 

Scientific writing 

• Design and drafting of the protocol. 
• Support in the preparation for funding applications and preparation of budgets. 
• Drafting of the patient information sheet and informed consent, as well as any other material aimed at the participant or patient. 
• Support in the preparation of documentation related to the product under investigation in accordance with the requirements established by current regulations. 

Regulatory activities: 

• Preparation of all the documentation required by the regulatory authorities and CEIm (Medication Research Ethics Committee) in both national and international projects. 
• Application for online assessment through the corresponding portals (CTIS, SARA, etc.) and response to requests from the competent authorities. 
• Preparation of economic reports. 
• Registration and maintenance of study information through the clinicaltrials.gov and Spanish Clinical Trials Registry (REEC) platforms. 
• Preparation and submission of amendments. 
• Support for taking out insurance policies. 
• Support in the payment of evaluation fees. 
• Support in the management of national and international contracts. 
• Notification and preparation of reports required by the health authorities. 

Project management 

• Comprehensive coordination of the clinical trial, which includes activities such as coordination of the centres participating in the study, logistics in the shipment and reception of the research product, management and coordination of samples, preparation of meetings with researchers, etc. 
• Preparation of specific documentation for the study, such as the drafting of specific manuals, monitoring plans, risk management plan, DSMB Charter, etc. 
• Resolution of queries from the research team. 
• Design, preparation and maintenance of the study files (Investigator Site File and Trial Master File). 
• Control, management and notification of deviations from the protocol, Good Clinical Practices and current regulations. 
• Support in the preparation of the Electronic Data Collection Notebook (eCRD). 
• Support to the sponsor in the financial management of the trial. 
• Preparation of the final report. 
• Communication of results in public records according to regulatory requirements. 

Monitoring 

• Clinical trial initiation, monitoring and closure visits. 
• Online revision of the eCRD and reviewing and resolving of queries 
• Support for the research team during the clinical trial. 
• Coordination of monitors in the case of both national and international multi-centre studies. 

Pharmacovigilance 

• Preparation of the Master Pharmacovigilance File. 
• Registration of Investigational Medicinal Product (IMP) with EudraVigilance. 
• Preparation of the Safety Management Plan for the clinical trial. 
• Management of serious and non-serious adverse events. 
• Reconciliation of adverse events with the marketing authorisation holder. 
• Reports of Unexpected Serious Adverse Reactions to the competent authorities through EudraVigilance. 
• Preparation of the annual safety report.