Further to the posts in the thread, here is an article that throws light on overuse of note to files,In what ways are notes to file overused, and what are considered to be inappropriate uses of notes to file?
There certainly seems to be a growing consensus among industry clinical research professionals that notes to file, while useful, are overused. Although such notes can be an important tool in documenting a study and in helping monitors, auditors and inspectors reconstruct how a study was conducted, their overuse can raise questions. Sam Sather
, vice president of Clinical Pathways, cautions that too many notes to file can raise concerns of auditors and regulatory inspectors over why there were so many issues with study procedures or study documentation. What is worse, says Sather, is when a note to file contradicts other study documentation, a situation that will certainly raise red flags and can be damaging in an inspector’s assessment of a study.
Examples of inappropriate uses for notes to file include many situations in which the subjects of the notes have already been addressed sufficiently in other study-related documentation. According to Sather
, examples include the following:
• The CRA authors and places a NTF in the site study file that is related to a site action or inaction, not a sponsor-specific issue. Because this issue involves a site action/inaction, the author in this case should be a member of the site staff (the clinical investigator or appropriate delegate). An example of a sponsor/CRA appropriately initiated memo or note to file would regard study management or sponsor services or notices to sites (as in the example in the immediately previous question). These are seen in many formats: letters, faxes, emails and memos (e.g., protocol exception granted (specific to a certain site); clarification of completion of a certain page of CRF (to all sites)).
• A site deficiency has already been documented in another format, and the NTF is repetitive. For example, if the source documents note that the patient failed to take study medication as required by the protocol and that the patient was reinstructed, a note to file documenting this would be repetitive. Also, actions to be taken to assess whether the re-teaching was effective could be written directly in the source documentation.
• Assume that a site did not consent the patient on the correct version of the informed consent, but that the site contacted the IRB by email about the error, stating that it has scheduled a patient visit on a specific date for reconsenting and that it has implemented a specific plan to prevent a repeat of such cases. In this case, the existing documentation would be sufficient, and a note to file
repeating this would be repetitive.
• An NTF documenting that the patient was not consented prior to study procedures is signed by the clinical research coordinator and is placed in the subject’s study file. First, the NTF content is not valuable when it simply points out the error. To be valuable documentation, the NTF should also include why this happened, the actions that were taken/will be taken to address the deficiency, the steps that will be taken to prevent this situation from recurring, and how the effectiveness of the intervention will be evaluated. Secondly, the content level of the NTF dictates that the principal investigator author the note. While the third party can template the NTF, the investigator really must review, approve and sign the note due to the severity of the issue.
Memos to file have been mentioned in several FDA warning letters in recent years, most recently in an October 2007 warning letter. “Our investigation found that [the sponsor] failed to take any action to secure compliance while the study was ongoing except to generate numerous memos to the file after all the subjects had completed the study….,” the FDA states in the warning letter. “We note that generation of numerous memos to file after all subjects have completed the study does not adequately secure compliance of an investigator.”
Although the sponsor indicated to the FDA that the memos to file were used “as a mechanism to train the investigator,” the sponsor conceded that the value was limited given that the majority of the memos were generated after all subjects had completed the study.
Other FDA warning letters acknowledge the existence of notes to file, but seem to suggest that site staff did not include complete information in such documents. A common issue appears to be that a note to file may document that there was a specific issue or problem (in some cases restating issues that are already in the source documents), but fails to address what the sponsor/site did to address a deficiency and to prevent similar problems in the future, says Sather