The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is a selection of questions and answers excerpted from the CenterWatch publication GCP Questions, FDA Answers.

This issue’s questions involve a site where administrative errors in documents, such as an incorrect date on the header of a monitoring visit confirmation letter, were previously dealt with by the monitor issuing a revised version of the document. The inquirer wonders if leaving the original, erroneous versions of documents in the trial master file (TMF) could result in confusion later on, especially for longer trials, and asks if the issuance of a corrected replacement letter, along with an email notifying the site of the correction for audit trail and justification purposes, would suffice in situations where the monitoring visit has not yet occurred.

Question: Are there any specific regulations surrounding the best practices for documents that have been already issued/provided to the site? Should the monitor not issue a revised (corrected) letter if an error is identified? What should be done with duplicates?

Answer: The FDA regulations do not specifically address your question about best practices for document management but do address which documents must be maintained for FDA?regulated clinical investigations. When the regulations are silent, sponsors, CROs, investigators, IRBs and institutions are free to develop their own procedures and practices as long as applicable regulatory requirements are met. Some FDA guidance documents, such as Electronic Source Data in Clinical Investigations, suggest that data should be attributable, legible, contemporaneous, original and accurate (ALCOA) and must meet the regulatory requirements for recordkeeping. This recommendation applies to all records (e.g., hard copy or electronic).

How and when your company decides to make corrections to study documents is something you should discuss with the appropriate company officials. Study records must be accessible to the FDA on an inspection so there is an expectation that the records will be adequately maintained. Your organization, or any sponsor you are working with, may have a standard operating procedure (SOP) that addresses document management (including document corrections) that you need to follow. As you noted, when an error is discovered, there should be an appropriate audit trail to explain what transpired. If not, there could be confusion surrounding what appear to be duplicate documents.

There is flexibility in the methods you can implement to manage study documents. You may find publicly available information regarding what some call “best practices” or “good documentation practices” that may be helpful to you in developing an SOP to address document management for your organization that best suits your business needs.

Question: Are investigational sites (and CROs) allowed to destroy/remove the incorrect letter (or any documents with errors) from their files if a revised, corrected version is issued? And if not, what is the best practice if they find a document that serves the same purpose but is “slightly” different from another? (i.e., one is the correct version, the other contains incorrect information).

Answer: Again, the FDA regulations do not specifically address your question. In general, removing/destroying study documents from study files is typically not recommended. As noted in the previous question/response, there is flexibility in the methods you can implement to manage study documents and create adequate audit trails to address errors in study documents and/or to identify duplicate documents. Developing an SOP that best suits your business needs is also recommended to provide a consistent method for all in your organization to follow.

For more information on the publication GCP Questions, FDA Answers, click here: https://bit.ly/3EhS2vg.