Data collection checklist

Informing investigators checklist

Investigators should be informed of trial closure via a letter. The letter should:

thank the investigator for their participation
summarise patient status - number of withdrawals, deaths, SUSARs, SAEs etc.
remind the investigator of any continuing trial obligations e.g. archiving
availability for queries after trial closure
arrange for the return of trial supplies and/or drug supplies, if applicable
advise of the possibility Eof audit or inspection if applicable
outline the results of the trial or provide a copy of the trial report
inform the investigators, if possible, of the expected timing of the publication.

This has been contributed by Barbara Farrell who prepared it for the third version of the Trial Management Guide.