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Study Coordination

The core area of GAIC is Study Coordination. The team comprises a group of specialized Study Coordinators (SC), highly qualified and well trained with an extensive experience in clinical research. 

Study Coordination activity aim to facilitate and coordinate the day-to-day activities of cardiovascular research projects. SC are able to support screening, enrollment, retention and follow-up activities, ensuring, together with researchers, the compliance with study protocol, Good Clinical Practice (GCP) and local legislation. They also manage study visits and procedures according to study timelines, ensuring data collection and its insertion on the Case Report Forms (CRF) in a timely manner, according to quality standards and Sponsor procedure. An important part of the work of this team is to make sure that recruitment targets are met and if needed, strategies can be adapted to maximize the number of participants recruited. SC also assists safety reporting and all monitoring activities. Overall, SC manage all aspects of conducting clinical research and they act as liaison between the sponsor, the principal  investigator and research team and well as the local Research Ethics Committee (REC) at the Academic Medical Centre of Lisbon (CAML). 

Additionally, SC also gives support to feasibility processes, and assists Principal Investigators (PI) in regulatory submission processes and follow-up, whenever requested.

In summary, GAIC assists research teams in the following tasks:

  • Research center feasibility and site qualification visits;
  • Study submission to CAML Research Ethics Committee;
  • Site activation (e.g., Site Initiation Visit, worksheets and study forms creation, site resources management, etc.);
  • Participants screening and enrollment;
  • Follow-up visits and patient´s procedures;
  • Source documents and electronic Case Report Forms (eCRF) management, including query resolution;
  • Assisting in Medication dispensation/return at Pharmacy;
  • Safety reporting;
  • Support in the monitoring activities.

Please contact ous if you need this service.

Team reference contacts

                             

Raquel Pires, PhD                                    Andreia Rocha, MSc.                          Susana Silva, MSc.

raquelpires@medicina.ulisboa.pt           asrocha@medicina.ulisboa.pt           susanaftsilva@medicina.ulisboa.pt

 

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