Table 1.

CRC activities, divided in different areas, modified from Rico-Villademoros F et al. 2004.

Administrative activities
Feasibility questionnaire completion Management of IRB submission (protocol and amendments), periodical trial reports (AE/SAE communication, first patient enrollment, close-out visit) Collaborate with Sponsors and CRO for study documents Management of Hospital Director submission Scheduled protocol specified tests Scheduled patient's CT appointments Contract and budget revision
Monitoring activities Patient registration/randomization procedures (IVRS/IWRS) To deal with Hospital Pharmacy and drug accountability IP dispensation (IVRS/IWRS) To deal with central lab and facilities (temperature log, calibration certificate …) Prepare and process lab kits for central lab Recruitment follow-up CRF completion To collaborate with the CRA during the study and site monitoring visits Queries resolution Reporting serious adverse events To handle the investigator file and source documents To prepare and/or attend audits Identification and revision of SOPs (if applicable)
Data management and statistics Database set-up Data entry Statistical analysis
Researcher-related activities Participation in protocol/CRF design Participation in protocol/CRF review Attending investigators meeting Participation in Final Report Participation in CT publication
Clinical activities (if applicable) To identify potential eligible patients Assessment of inclusion/exclusion criteria Participation in informing of patients Participation in obtaining informed consent To assess response to therapy To assess toxicities Scales/questionnaires completion