1B01 Preparation and Maintenance of Case Correspondence

Investigators must update and maintain an evaluation’s correspondence in CMS for each compliance evaluation. This log is an invaluable tool and an integral part of tracking the progress and the status of the case. It is, therefore, important that Investigators keep the correspondence up to date with:

• Event summaries that begin with the initial contact with the contractor and continue through to the approval of case closing documents.
• Documentation of all telephone conversations, emails, correspondence and meetings associated with the evaluation, indicating the date, nature of the contact, person contacted, a summary of discussion or actions taken, and the Investigator’s name.

Records of telephone calls should include the time of the call. All meetings must include the date, location, and names of the people in attendance. In addition, Investigators must record all requests for data and records, and the dates the Investigator received these items. Any items received for the case should be uploaded into CMS. Investigators must record all events and actions as they occur.