Clinical
Training Company Vietnam (CTCVN) provides all SMO activities:
- Support in establishing and
managing Clinical office;
- Support in writing SOPs;
- Support in screening and
enrollment subject
- Support in consulting Inform
Consent Form
- Support PI in entering CRF / eCRF;
- Support in archiving and managing
all sources of data, as well as all of records and related documents;
- Support in conducting the trials
in compliance with protocols, SOPs and GCP (supervising and instructing all
procedures to ensure the proper implementation);
- Support in following up patients
(setting and reminding patients of visit schedule…);
- Check and prepare essential
testing kits;
- Support in checking and updating
information for required documents/ files (such as updating investigator file,
patient binder…);
- Support in managing
investigational products;
- Support in reporting AEs/ SAEs and
medical reports;
- Support for login, activation and
updating study web-based systems (if applicable);
- Prepare essential documents/files
to meet the monitoring and inspection from Sponsor
- Prepare essential documents/files
to meet the auditing from HA
- Support in activities related to
IRB operation;
- Support in Training
of research protocol, SOP and MOP
- Other supports requested by PI.
Each research site will have a CRC/CRA as the primary
contact point
