3.7 Site initiation
Before the trial treatment materials can be sent the coordinating centre must have in their possession the following documents:
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CV of Principal Investigator and sub-investigators
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Confidentiality Agreement signed (if applicable)
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Financial Disclosure form signed (if applicable)
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Principal Investigator Agreement signed
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Agreement of responsibilities signed (if applicable)
- Financial agreement (if applicable)
- Copy of national regulatory approval / import licence
- Copy of local research ethics committee approval
The principal investigator must ensure that all relevant staff members are aware of and in agreement with the trial. To this end the coordinating centre will provide training/presentation materials and full instructions on the trial procedures.
