Project Management and Clinical Trial Conduct
Ethic Medikal Araştırma Ltd. conducts project management and phase trials in line with ICH GCP and local regulations, with an experienced team.
The company manages all stages of local and international trials, including feasibility, site selection, trial conduct and site close-out.
The duties of our trial monitors are not limited to those listed below; they also carry out responsibilities specific to each trial protocol.
Responsibilities of the clinical trial monitor
- Carrying out site monitoring responsibilities at a minimum of one site as the responsible monitor
- Assisting in the development of trial protocols, protocol amendments and informed consent forms
- Assessing investigators and clinical trial sites
- Providing protocol, regulatory and protocol-specific training to site teams as required
- Monitoring sites in line with the protocol, ICH GCP and local regulations
- Submitting project documents and essential documents to the Ethics Committee and Ministry of Health
- Attending investigator meetings
- Maintaining and developing the trial master file
- Conducting initiation, monitoring and close-out visits in line with national and international regulations
- Reviewing case report forms and source documents for compliance with the protocol and regulations
- Resolving inconsistencies in case report forms and ensuring necessary clarifications are made
- Performing drug accountability at sites
- Ensuring adverse event and serious adverse event reporting is carried out
- Documenting pre-study, initiation, interim and close-out visits
- Performing all duties in line with ICH GCP and other local and international regulations
- Ensuring site files are current and complete
- Following up trial progress reports
- Conducting trial monitoring in line with agreed timelines
- Visiting different sites for monitoring purposes
- Attending training