Warning Letter: Inadequate records (ucm271583)

Failure to maintain adequate drug disposition records raises concerns about subject safety and data integrity. We acknowledge that your written response states that upon your discovery of both the lack of drug accountability and the missing vials, pharmacy and research SOPs were evaluated and revised; and that future studies at your site will be conducted under the umbrella of US Oncology Research, which has an electronic drug accountability system. However, as the clinical investigator, it was your responsibility to ensure that adequate records of the disposition of the drug were maintained; and US Oncology Research’s policies, procedures, and activities do not negate your responsibility as the clinical investigator.

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Warning Letter: Failure to follow 21 CFR 11 compliance (g5276d)

Our review of the inspection results also noted that you use an electronic medical record (EMR) system to maintain medical and other clinical data for your patients, including study subjects . You told Mr.  [redacted] that data obtained during study visits are entered directly into the EMR, and no paper records are used. A follow-up letter from you to Mr. [redacted], dated January 31, 2005, detailed the name of the EMR system and the means by which study subject information is entered. Please note that Title 21, Code of Federal Regulations, Part 11, “Electronic Records; Electronic Signatures ” outlines specific requirements that must be met for any system that is being used to maintain required records. In addition to the information requested above, please submit the following:

• Documentation of the validation of your EMR system to ensure accuracy, reliability, and the ability to detect invalid or altered records;
• Documentation of the ability to generate accurate and complete copies of records suitable for inspection, review, and copying by the agency;
• Documentation of a secure, computer-generated, time-stamped audit trail that can independently record the date and time of operator entries and actions that create, modify, or delete electronic records, and to verify that record changes do not obscure previously recorded information.

View the original warning letter.