FEASIBILITY:

– evaluation of patient population and recruitment prospects based on the assumptions of the Study Protocol
 and the inclusion/exclusion criteria provided.

 

START UP:

– prompt contract signing process (financial agreement with the site only)

– prompt collection and delivery of required documents (CVs, lists of publications, overview of the site and personnel qualifications,
   Protocol signature pages, etc.)

 

INITIATION:

– excellent knowledge of the Study Protocol, adverse reactions specified in the Investigator Brochure, Lab Manual,
   CRF completion rules, adverse events reporting rules

– completion of project specific courses and active participation in the Meeting of Investigators

 

RECRUITMENT:

– large patient base (according to ICD-10) ensuring effective and prompt recruitment

 

INTERIM MONITORING:

– ensuring patient safety

– patient visits planned in accordance with the Study Protocol

– careful execution of the study procedures, timely completion and dispatch of CRFs/e-CRFs

– immediate evaluation of laboratory tests results

– immediate resolution of QUERIES

– diligent following of all procedures regarding the investigational drug storage,
   distribution and receipt as well as keeping detailed records thereof

 

CLOSE OUT:

– prompt resolution of all QUERIES

– return or destruction of the investigational drug in accordance with Sponsor's instructions

– archiving the study records in compliance with the applicable laws