SITE MANAGEMENT ORGANIZATION (SMO)

Clinical Training Company Vietnam (CTCVN) provides all SMO activities:

1. Support in establishing and managing Clinical office;
2. Support in writing SOPs;
3. Support in screening and enrollment subject
4. Support in consulting Inform Consent Form
5. Support PI in entering CRF / eCRF;
6. Support in archiving and managing all sources of data, as well as all of records and related documents;
7. Support in conducting the trials in compliance with protocols, SOPs and GCP (supervising and instructing all procedures to ensure the proper implementation);
8. Support in following up patients (setting and reminding patients of visit schedule…);
9. Check and prepare essential testing kits;
10. Support in checking and updating information for required documents/ files (such as updating investigator file, patient binder…);
11. Support in managing investigational products;
12. Support in reporting AEs/ SAEs and medical reports;
13. Support for login, activation and updating study web-based systems (if applicable);
14. Prepare essential documents/files to meet the monitoring and inspection from Sponsor
15. Prepare essential documents/files to meet the auditing from HA
16. Support in activities related to IRB operation;
17. Support in Training of research protocol, SOP and MOP
18. Other supports requested by PI.

Each research site will have a CRC/CRA as the primary contact point