SZTE

University of Szeged webpage Faculty of Medicine webpage Albert Szent-Gyorgyi Health Center webpage

university of szeged

clinical research coordination office

13. dugonics tér, szeged, Hungary H-6720
+36 62/54-68-95
clin.trial@rekt.szte.hu

Quality assurance and on-site monitoring

Clinical Research Coordination Office takes part in quality assurance in the following tasks:

- Our colleagues assess the infrastructural and human resource status of trial sites, on the basis of which we develop the quality assurance system for clinical trials at the University of Szeged.

- We develop and provide Standard Operating Procedures (SOPs) of clinical trials for the sites at the University of Szeged. These SOPs are reviewed every two years.

- Evaluation and monitoring of the GCP compliance of sites.

Our Office currently has the following Standard Operation Procedures:

1. Standard operating procedures for archiving
• Archive policy

2. Standard operating procedures for organizing of clinical trials
• Site selection visit procedure
• Site initiation visit procedure
• Patient Information Sheet and Informed Consent Form
• Preparation and management of study source documents and patient data sheets
• Handling and supervision of shipments during clinical trials
• Management of Investigational Products
• Handling and reporting of Serious Adverse Events
• Close-out visit procedure
• Internal monitoring

3. General Standard operating procedures:
• Writing and handling Standard operating procedures
• Duties and responsibilities of investigator staff

4. Standard operating procedures related to technical activities and instruments/equipment
• Instruments and equipment used in clinical trials

5. Standard operating procedures for moving of the site
• Site moving policy

On-site monitoring

On-site monitoring means that a delegated colleague monitors the initiation and progression of trials by on-site visits and by follow-up letters of periodic monitoring visits sent by Sponsors/CROs. Based on these, our monitor records the development of the number of patients involved in the studies and any issues and findings that are highlighted by Sponsor/CRO.

However, the quality assurance tasks of our on-site monitor do not replace the regular in-house assessments and self-evaluations of the sites, for which evaluations the leaders of the sites are responsible.

Contacts:

Judit REKECKI MAJOR – Quality assurance manager
Phone: +36 62/54-68-41
E-mail: rekecki.major.judit@rekt.szte.hu

Sándor RÁTKAI Pharm.D. – On-site monitor
Phone: +36 62/54-55-45
E-mail: ratkai.sandor@rekt.szte.hu