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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 extensive experience in clinical research. 

The activity of study coordination aims to facilitate and coordinate the activities of day-to-day research projects in progress. The SC are able to provide support to the activities of screening, inclusion and follow-up of participants, guaranteed, together with researchers, the compliance with the Study Protocol, Good Clinical Practices (GCP) and local legislation. They also manage the study visits and procedures, according to the deadlines of the study, guaranteeing the collection of data and its insertion in Case Report Forms (CRF) in a timely manner, according to quality standards and procedures of the Sponsor. An important part of the SC's work is the certification that the recruitment goals are successfully achieved and if necessary, the suggestion of adopting strategies aimed at maximizing the number of recruited participants. The SC al research and acts as a point of contact between the Sponsor, the Principal Investigator and the research team, as well as with the Ethics Committee on Health (CES) of the Centro Académico de Medicina de Lisboa (CAML).

In addition, the SC also provides support in the qualification process of the Centre (feasibility) and in the processes of regulatory submissions and follow-up, where necessary.

In summary, GAIC provides support in the following activities/tasks:

  • Site feasibility process and 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.);
  • Support in screening visits and inclusion of participants;
  • Support in follow-up visits and participant procedures;
  • Source documents and electronic Case Report Forms (eCRF) management, including query resolution;
  • Assisting in Medication dispensation/return at Pharmacy;
  • Support in the monitoring activities.

Please contact us if you need this service.

 

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