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What should be facilitated in Multicentre Trials according to ICH GCP?
ICH GCP states that in Multicentre Trials all investigators are given instructions on which of the following:
1. following the protocol
2. complying with a uniform set of standards for the assessment of clinical and laboratory findings
3. completing the CRFs
According to ICH GCP the sponsor should ensure that for mulitcentre trials the responsibilities of who are documented prior to the start of the trial?
According to the Multicentre Trials section of ICH GCP when should supplemental CRFs be provided?
According to the Multicentre Trials section of ICH GCP what should all investigators do?
1. conduct the trial in strict compliance with the protocol agreed to by the sponsor
2. conduct the trial in strict compliance with the protocol agreed to by the regulatory authority(ies) if required
3. conduct the trial in strict compliance with the protocol given apporval/favourable opinion by the IRB/IEC