E6: Multicentre Trials

Question 1

Multicentre Trials
For multicentre trials, the sponsor should ensure that:

5.23.1

Answer 1

All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies), and given approval/favourable opinion by the IRB/IEC.

Question 2

Multicentre Trials

5.23.

Answer 2

The CRFs are designed to capture the required data at all multicentre trial sites. For those investigators who are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional data.

Question 3

Multicentre Trials

5.23.

Answer 3

The responsibilities of coordinating investigator(s) and the other participating investigators are documented prior to the start of the trial.

Question 4

Multicentre Trials

5.23.

Answer 4

All investigators are given instructions on following the protocol, on complying with a uniform set of standards for the assessment of clinical and laboratory findings, and on completing the CRFs.

Question 5

Multicentre Trials

5.23.

Answer 5

Communication between investigators is facilitated.