WP02 Coordinating Centre


 

Work Package Lead: Prof. Rafael Gabriel

02. SERVICIO MADRILENO DE SALUD – SERMAS (ES)

 

Objectives:

  • Develop the RCT protocol and the Clinical part of the Operations Manual.
  • Prepare the clinical package training.
  • Distribute optional clinical packages to clinical centres according to their potential/willingness.
  • Follow up recruitment and support to clinical centres to solve barriers to Recruitment.
  • Centralise and coordinate request and suggestions from clinical centres for consideration at SC.

 

Main tasks:
1. Development of the study protocol and clinical part of the operation manuals in collaboration with WP 1, 3, 4, 5, 6, 7, 8 and 9:

  • Final study design and sample size calculation and adjustment for the trial (leaded by FIRCAVA (partner 1).
  • Definition of study population and eligibility (inclusion and exclusion) criteria for participants and development of the final study protocols. (leaded by FIRCAVA (partner 1).
  • Development of screening tools, strategies and recruitment procedures for clinical centre 
(The CT investigators guide).
  • Describe the contents of screening, baseline and follow-up visits, and trial procedures.
  • Development of patient materials (the CT patients guideline) to facilitate the participation, 
enhance adherence and support patients during the trial.

2. Training, standardization, and certification of clinical investigators:

  • Organize a training program and certification program for clinical investigators for all clinical procedures and specific techniques to be used in the CT (in cooperation with WP 3, 4, 5,6, 7 and 9).
  • Establish a quality control program for periodical assessment of key measurements and re-certification when necessary (in cooperation with WP9).
  • Describe and disseminate the contents (the screening and clinical procedures) of the CT investigators guide and the CT patients guide (in cooperation with WP 10).

3. Coordination and support of clinical centres during CT field works:

  • Distribution of patients numbers and adjustments by centre in cooperation with WP9
  • Surveillance of the overall CT calendar, patient recruitment rate by centre, and feed-back to 
clinical centres
  • Assessment of acceptability and adherence to the intervention program (drugs and lifestyle 
interventions) by participants and physicians in cooperation with WP3 and 9.
  • All clinical centres will work under this WP.
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