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3.8 Trial Materials

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At the start of the trial the coordinating centre will provide the investigator with the trial materials.

Treatment drugs containing detailed guidance on storage, administration and expiry dates. Click to the button on the right for Section 6 guidelines regarding drug accountability.

Study file: Contact information; forms, guidance and procedures; training materials; copies of approvals and agreements; filing space for trial related documentation such as case report forms, consent forms and correspondence. As the trial progresses more sections or items may be added.

Maintenance of the study file

Generic index of documents - trial specific documents may be added

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