The clinical research associates´ (CRAs) main goal is to ensure the rapid generation of reliable and high quality clinical data.
Clirophtha'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 follow a specific training concerning the Investigational Medicinal Product (IMP), the pathology, the goals of the study, the study protocol, the CRF, and the monitoring guidelines in order to make them familiar with the study.
Several times per year, our CRAs attend training courses
on Good Clinical Practice (GCP), on Clirophtha'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 of the subject information and informed consent signature.
100% source data verification
Checking consistency of the Case Report Form (CRF) data.
Monitoring of the patient eligibility criteria, examination of adherence to protocol and amendments.
Up date of the adverse events and the serious adverse event status.
Record of the patient status.
Keeping the study files up to date.
Investigational Medicinal Product (IMP) accountability and checking.
In-House Monitoring
Regular contacts with investigators.
Secondary monitoring of the CRFs.
Data query edition and management.
Monitoring visit reports.
Follow-up of the supply of IMPs, CRFs, etc.
