PRE-TRIAL Tasks

Create a clinical trial operation flow; prepare materials for case management; perform training based on the protocol; communicate/coordinate with study related departments

Tasks during informed consent / case registration

Verify subject eligibility; assist in creation of written informed consent; support case registration process

Support for trial subjects

Inquiry counter for trial subjects; confirmation/coordination of subject's hospital visit; drug administration guidance; verification of dosage intake (collection and return of surplus drugs); support to relieve burden of subject's expenses

Tasks duringtrial

Verify check items; communicate with Chief Investigators and investigators

Support for CRA (monitoring)

Inquiry and liaise with trial monitor, reporting and communication

Case Report Form (CRF)

Help prepare case report forms, confirm that required entry items are completely and properly filled out

Tasks regarding adverse events

Verification of detailed data; report to investigators; report to trial sponsor; support staff prepare reports

Coordination for monitoring/auditing

Prepare clinical records and other data; Source Data Verification support

Site support

Support, communication and coodination for trial related procedures; support for each department of an site to cope with the impact of trial initiation; management of trial progress status; preparation and management of trial related documents; support for monitoring and auditing

Site initiation

Preparation and distribution of site SOP (standard operating procedure); instruction on GCP to Chief Investigator/investigators; maintain trial system support; set-up and support site office

IRB (Institutional Review Board) support Management

Prepare and provide IRB's SOP; train IRB members and IRB staff; support IRB office