During an audit we were asked to provide evidence of medical monitor involvement. Initially we provided a log showing MM reivew (assessment, signature and date); however we were asked for additional evidence such as meeting invites and meeting minutes. These were filed in general correspondence and it took time to locate. Would you suggest filing these with the plan?
01.01.09 Medical Monitoring Plan
To describe how medical surveillance of trial subjects will be assured during the trial. Artifact can include any evidence of plan execution including, but not limited to: plan, reports, checklists, etc.
01.05.01 Relevant Communications Correspondence
Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but are not limited to: letters, memo, electronic communications and faxes. Correspondence referring to general topics and/or topics across multiple zones may be filed with this zone