Treatment allocation and Returned to sponsor to X document any decoding that decoding documentation may have occurred Pre-trial Monitoring Report (may To document that the site is X suitable for the trial be combined with Trial Initiation Monitoring Report) Trial Initiation Monitoring Report X X To document that trial procedures were reviewed (may be combined with Pre-trial with the investigator and the Monitoring Report) investigator’s trial staff Monitoring Visit Reports To document site visits by, X and findings of, the monitor Final Trial Close-Out Monitoring To document that all activities X required for trial close-out are Report completed, and copies of essential documents are held in the appropriate files Certificate (if available) To document that was X performed Relevant communications other To document any agreements X X or significant discussions than site visits (where required) regarding trial administration, Letters protocol violations, trial Meeting notes conduct, adverse event (AE) Notes of telephone calls reporting. Note this may include communications amongst the Trial Management Group members, between Trial Management Group and Data Monitoring Committee
Treatment allocation and decoding documentation Returned to sponsor to document any decoding that may have occurred X Pre-trial Monitoring Report (may be combined with Trial Initiation Monitoring Report) To document that the site is suitable for the trial X Trial Initiation Monitoring Report (may be combined with Pre-trial Monitoring Report) To document that trial procedures were reviewed with the investigator and the investigator’s trial staff X X Monitoring Visit Reports To document site visits by, and findings of, the monitor X Final Trial Close-Out Monitoring Report To document that all activities required for trial close-out are completed, and copies of essential documents are held in the appropriate files X Certificate (if available) To document that was performed X Relevant communications other than site visits Letters Meeting notes Notes of telephone calls To document any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event (AE) reporting. Note this may include communications amongst the Trial Management Group members, between Trial Management Group and Data Monitoring Committee X (where required) X