If any mistake occurs in trial master file like missing and wrong dates, any mistakes in the trials and some missing data in the trial master file, then a file is made and all the reasons are mentioned and specified within this file that is known as note to file that is also included in trial master file. The main purpose of this note to file is to explain any variation in trial master file.
- Note to file is helpful to improve trial master files as it highlights the mistakes been made but instead of putting this note to file in the trial master file, missing document should be added without any excuses. That document can be missing because of negligence of CRA that he missed that document and upload trial master files to the team. Note to file is not a proper solution. These mistake can be improved by focusing on the variation and the reasons that why it happen?
- These note to files make our trial master file weak as these note to files are there because of some missing documents and missing data that will weaken our data required for the trials and our trials will not go according to the plans and will not be successful.