In the period of clinical trial preparation
1. Feasibility research for the institutions
2. Management for expense budget
3. Contacting with IEC, assisting the investigators to submit the ethical
documents and manage related documents.
4. Preparing and management of the initiation meeting.
5. Training and coordination for the personnel in institution, pharmacy department in hospitals, clinical laboratory and investigators.
6. Keeping touch with the CRO and sponsor.
In the period of clinical trial conduction
1. Recruitment and screening, contacting and consultation of the subjects
2. Education, contacting and consultation of patients and their families
3. Management for the visit, coordinating to arrange the time for treatment
4. Check the report
5. Management of origin documents
6. Tracking and management of the adverse effect, assisting to report the SAE
7. Collating the CRF and origin documents, transcription and inputing the EDC data.
8. Management of documents and supplies in the investigation center.
9. Coordinating the monitoring, quality control and visit.
10. Management and transport of the samples in laboratories.
In the period of clinical trial termination
1. Assisting to collect the documents.
2. Finishing the data query.
3. Checking and collection of drugs and supplies used in the trial.
4. Collection and management of bills and notes.
5. Collation and collection of the programme documents.