eProtocol

Monitoring

Unlike institution based HRECs Bellberry does not have the benefit of Investigators being located on site. Bellberry is very aware of its responsibility to ensure that site monitoring and review occurs and conducts an ongoing site monitoring program.  To assist in this process, Bellberry conducts site monitoring.

Individual sites are contacted initially by Bellberry. The site monitor then liaises with individual sites to establish mutually acceptable visit dates and times. The site monitor reports as per the National Statement and includes information on the site facilities. Following review of the reports any required action is referred back to the Principal Investigator with time frames for resolution. The reviews also provide Bellberry’s customers the opportunity to provide feedback.

Bellberry HREC monitors approved trials in the following ways as per the National Statement Chapter 5.5.

  • Please click here to access the Policy PI009a – Site Monitoring
  • Please click here to access Policy PI019 – Protocol Violations
  • Please click here to access the Policy PI009 – Monitoring Serious Adverse Events Reports
  • Please click here to access Policy PI004 – Adverse Event and Safety Reports (including Flowchart)
  • Please click here to access Policy PI0010 – Progress Reports

Site visits

Individual sites are contacted by Bellberry to establish mutually acceptable visit dates and times.  Reports as per the National Statement include information on the site facilities and the conduct of selected studies in relation to the approved Protocol.  Following review by the relevant Committee, any required action is referred back to the Principal Investigator with time frames for resolution. The site monitoring visits also provide Bellberry’s customers the opportunity to provide feedback.