Warning Letter: Failure to follow Protocol (ucm 366762)

Tags: Clinical Investigator | Clinical Research Organization | Data Integrity
June 5, 2013

Protocol [redacted] required that you dispense a handheld electronic device (LogPad) to subjects at Visit 2, prior to surgery, and that the subjects record their pain assessments in the LogPad during the study. You did not dispense a LogPad to Subject 09-006 at Visit 2 on March 4, 2011, because the subject was sedated and on a ventilator. In addition, five pain assessments for Subject 09-006 were entered into the LogPad by the study coordinator, rather than by the subject. During the inspection, your study coordinator indicated that she used the subject’s login code and entered the subject’s pain-assessment scores into the LogPad when the subject was unable to provide a pain score. In your October 3, 2012, written response, you acknowledged that the LogPad was not dispensed to Subject 09-006 prior to surgery. You noted that after surgery, the subject was put on a “vent” (ventilator), was sedated, and was unable to participate in the evaluation of pain, via the LogPad or otherwise….

…By failing to ensure that pain-assessment data were entered only by the subjects, as required by the protocol, you compromised the validity and integrity of data collected at your site. Protocol [redacted] required that the subjects record their pain assessments in the LogPad during the study. For Subject 09-006, the LogPad contained assessments purportedly made and entered by the subject; however, five pain assessments were entered by the study coordinator and reflect the study coordinator’s or nursing staff’s assessments, rather than the subject’s assessments.

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Warning Letter: eCRF lacks laboratory values (ucm340269)

Tags: Clinical Research Organization | Computer System | Design Validation Inadequate
March 6, 2013

As an investigator, you are responsible for maintaining accurate, complete, and current records relating to the investigation. (See 21 CFR 812.140(a)). You failed to adhere to the above-stated regulations. Examples of these failures include, but are not limited to the following: a. (b)(6) • The Electronic Case Report Form (eCRF) lacks baseline vital signs, permanent pacemaker) interrogation findings, or laboratory values.

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Warning Letter: Uncontrolled database (m4116n)

Tags: Clinical Research Organization | Database | No Audit Trail | No Procedure for Training
August 30, 2000
 
"...It is also noted in the inspection report that you do not have adequate control over the receipt of study data and its subsequent input into the database. There are no records to show when study data is received and when it is entered into the database. There is also no . No data queries or clarifications have ever been generated and sent to the sites to verify missing information or to clarify discrepancies... , Electronic Database Maintenance, are subject to 21 CFR Part 11- Electronic Records; Electronic Signatures, as well as to the record keeping regulations found in 21 CFR 812.140. A guidance document regarding this regulation, Computerized Systems Used in Clinical Trials, dated April 1999. www.fda.gov/ora/compliance ref/bimo/ffinalcct.htm"

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