Non-compliance with a clinical trial protocol may be costly and/or harmful to the subjects, the investigator, Yale, the scientific community and the public at large. Investigators conducting clinical research trials are encouraged to evaluate if appropriate practices are in place to ensure their protocol is followed as approved by Yale’s Human Investigation Committee (HIC). Insight into the types of practices FDA auditors currently consider unacceptable may be enhanced by reading the FDA’s Warning Letters.
Clinical investigators who were issued FDA Warning Letters in 2013 included:
1) An investigator in Boston, Massachusetts because:
- Certain subjects were given incorrect investigational drug doses
- Orders for the investigational drug were placed by surgical residents who were not included on the FDA 1572 form
- The investigational drug was ordered prior to randomization
- Informed consent was obtained by physicians not included on the signed FDA 1572 form
- Source document data such as body weight and height were missing, estimated or self-reported
- Subjects were not contacted or scheduled for protocol-required follow-up that resulted in failure to capture adverse events
- The informed consent document was missing for 1 subject and the copy used to consent other subjects was expired at the time it was obtained
2) An investigator in Pittsburgh, Pennsylvania because:
- Enrolled subjects did not meet the (best corrected visual acuity) inclusion criteria
- A specific data point (visual acuity) was measured by uncertified personnel
- The (visual acuity) examiners did not follow study procedures (in remaining masked to the study eye when measuring intraocular pressure)
- The person who documented as performing the (eye) exam in the subjects’ medical record was not the person listed on the sponsor’s (visual acuity) worksheets
- Subjects underwent certain (screening) study procedures prior to signing the consent
3) An investigator in Palm Beach Gardens, Florida because:
- Certain subjects were given a different treatment (comparator and study device) than assigned by randomization (compromising the reliability and introducing bias)
- No device accountability records were maintained
- Subjects were initially consented with an unapproved version of the informed consent
- Copies of the consent forms initially signed by certain subjects were not available
- Data and signatures were missing from case report forms
Copies of these and other FDA Warning Letters are available to the general public at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm339597.htm#DDMAC.
Submitted by Judy Guay and Kathy Engle