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Table 1 Clinical Operation Services offered by ISG CTU

From: How a Clinical Trial Unit can improve independent clinical research in rare tumors: the Italian Sarcoma Group experience

Scientific support

Protocol development

 Support to the coordinator physician within the study board, for the implementation of the ethical aspects and safety requirements of research

Study report, publication and result dissemination

 Support to the final study report, publication submission and dissemination of the study results

Study project management

Study budget plan and budget negotiation

 Evaluation of study costs, budget plan development and budget negotiation with pharma companies supporters of the independent research or with partners within consortium projects

Study feasibility

 Support to sites selection through site feasibility development within the study board

Regulatory documentation

 Preparation of the regulatory documents, preparation and maintenance of the study binders in accordance with Good Clinical Practices and ISG Clinical Trial Standard Operating Procedure (SOP)

Regulatory submission

 Submission to the Competent Authorities and Independent Review Boards (IRB) of the regulatory (protocols, patient’s information sheet and informed consents, Investigational Product information, safety information and all the others applicable documents)

 Support activity in the preparation of the submission package for extra-Italian submission within international studies coordinated by ISG

Investigational Product (IP) activities

 Management of the IP from labeling (if required) to supply and resupply activities

Database development

 Support to the Case Report Form design

Investigators meetings

 Support in the organization of the Investigators Meetings and logistics

Monitoring activities

 Management and conduction, either remote and onsite, of the site activation, monitoring and close-out visits

Coordination of centralized activities

 Development of procedures for centralized activities (samples management in case of centralized biological material analysis, centralized imaging review management)

Communication with the sites

Study state of art continuous monitoring

Regulatory and safety management

 Safety regulatory activities conducted by the Pharmacovigilance Office

 Communication of safety information (SUSAR, SAE line listing) to Competent Authorities and sites

 Eudravigilance reporting activities

Educational

 Protocol training activities

 Training on GCP, regulatory and clinical operation

Administrative

 Protocol budget plan

 Site contract negotiation

 External services contract negotiation