Investigators should follow the regulations governing the conduct of clinical trials in their own country. If the trial is initiated within the European Union (EU) the Coordinating Centre should comply with the EU directive 2001/20/EC.

If you need information about the regulations in your country, please refer to the list of national regulatory bodies. The principal duties of an investigator are:

• Obtaining local ethics approval
• Recruiting and treating patients according to the protocol and applicable guidelines
• Recording all required trial data including adverse events and serious adverse events
• Informing the Coordinating Centre of any adverse events according to guidelines
• Discussing the trial with medical and nursing staff and ensure that they remain aware of the state of the current knowledge, the trial and its procedures (the Coordinating Centre will send you training materials to assist with this)
• Ensuring that suitable adults are considered promptly for the trial
• Ensuring that the case report forms are completed and submitted to the Coordinating Centre in a timely manner
• Ensuring the trial is conducted in accordance with ICH GCP and fulfils all national and local regulatory requirements
• Allowing access to source data for audit and verification

Investigator's responsibilities