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CRA

The clinical research associates´ (CRAs) main goal is to ensure the rapid generation of reliable and high quality clinical data.

 

Iris Pharma's CRAs achieve this goal not only because they maintain a close cooperative relationship with the European investigators network, but also because they are thoroughly and regularly trained. Before a new study, they undertake a specific training concerning the Investigational Medicinal Product (IMP), the ocular pathology, the goals of the study, the study protocol, the CRF, and the monitoring guidelines to ensure they are familiar with the study.

 

Several times a year our CRAs attend training courses on Good Clinical Practice (GCP), on Iris Pharma's new Standard Operating Procedures (SOPs) and on pathologies in ophthalmology.

 

The main activities of the CRAs are on-site and in-house monitoring.

 

ON-SITE MONITORING

  • Pre-study visit (when required), site initiation, follow-up visits and site closure
  • Checking subject information and informed consent signatures
  • 100% source data verification
  • Checking consistency of Case Report Form (CRF) data
  • Monitoring patient eligibility criteria, and examination of adherence to protocols and their amendments
  • Updating the status of Adverse Events (AE)s and Serious Adverse Events (SAE)s
  • Recording patient status
  • Keeping the study files up to date
  • Investigational Medicinal Product (IMP) accountability and checking

 

IN-HOUSE MONITORING

  • Regular contact with investigators
  • Secondary monitoring of the CRFs
  • Data query editing and management
  • Monitoring visit reports
  • Follow-up of the supply of IMPs, CRFs, etc
  • European and International guidelines