Protocol Deviations Prompt 483s for Clinical Investigators
Three clinical investigators were cited for deviating from their investigational plans recently by the FDA for a litany of different reasons.
The FDA issued a Form 483 to Brian Driver of Hennepin County Medical Center for failing to report three patient deaths after experiencing serious adverse effects. The serious adverse effects had not been documented, reviewed or evaluated, as required by protocol, inspectors noted.
Inspectors also reported discrepancies in Driver’s evaluation of adverse effects, with certain events that should have been categorized as life-threatening being documented as moderate, according to the 483.
Additionally, Driver administered the wrong dosage for nine subjects enrolled in a study, the document states. It notes that he also neglected to follow protocol for subject enrollment and randomization.
Lapses in recordkeeping for informed consent forms and source documents resulted in John Costouros of Stanford Medicine receiving a 483.
Specifically, the three-observation document states that one subject was enrolled in a trial without signing an IRB-approved consent form. Another subject signed an outdated version of the form, according to the document.
Source documents appeared to give multiple reasons for patient screening failures varied among copies, with inspectors noting that three different explanations were given for a single patient. The 483 lists several other instances in which source documents had been altered.
The last observation pertains to the enrollment of a patient in a study without verifying the subject met the inclusion criteria.
Kapiolani Medical Center
An agency inspector issued the final 483 to Desiree Medeiros, a clinical investigator for the Kapiolani Medical Center for Women and Children. The briefest of these documents, this one included a single citation because Medeiros did not follow an agreed upon investigational plan.
During an inspection between March and April, an inspector witnessed Medeiros depart from the established operating procedures by not calibrating the thermostat to monitor the storage of investigational products and lab specimens.
The same observation includes a notation that Medeiros did not follow protocol because she did not wait for approval from the trial’s sponsor.
Read Brian Driver’s 483 here: www.fdanews.com/07-07-16-BrianDriver483.pdf.
Read John Costouros’ 483 here: www.fdanews.com/07-07-16-JohnCostouros483.pdf.
Read Desiree Medeiros’ 483 here: www.fdanews.com/07-07-16-DesireeMedeiros483.pdf. — José Vasquez
Subscribe to Drug GMP Report NOW and save $200 off the regular one-year price of $1,045. Plus receive a free copy of our webinar CD - GAMP Classification for Pharma Equipment and Software Systems - $287 value.
LINKS TO KEY DOCUMENTS — You get links to key documents that support DGR's articles such as draft and final guidances, Form 483s, warning letters, proposed rules, closeout letters and much more.
FDANEWS DRUG DAILY BULLETIN — This daily email alert brings you targeted FDA regulatory, legislative and business news briefs in the pharmaceutical and biologics industries.
ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.
Copyright ©2019. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing