Notes to file for clinical trials are a somewhat tricky issue. How do you maintain “adequate and accurate” subject source documents and do notes to file help? They seem to be ubiquitous these days and I am not sure it is a good thing. Here are some rules that I tend to follow for a note to file at the clinical site:
1. The source documents at the site are the responsibility of the clinical investigator (PI) and her/his staff. A clinical research associate (CRA) who is monitoring the site should not write a note to file and then instruct the PI or study coordinator to sign it. The note to file is written according to the policies of the SITE, not of the sponsor or CRO. The person signing the note to file should be the person Writing the note to file.
2. Notes to file work best when they document what you did Right, not what you did wrong. If you are attempting to document a corrective action, then document the training or measures taken. Is it necessary to duplicate that documentation in a note to file?
3. All too often a note to file is generated because someone somewhere wants to “close out” an audit or monitor visit finding. That documentation belongs to the sponsor or CRO, not the site. There is no clinical trial regulation requiring a clinical site to maintain the sponsor’s notes to file or other sponsor-specific documents.
4; Don’t write a note to file in haste. Remember that it becomes part of the official documentation of the clinical trial. If you or someone else write a note to file that says something inappropriate, it is maintained for posterity for the regulatory required length of time.
Read other posts on Good Clinical Practice:
Read the article on Notes to File from Applied Clinical Trials: