Transcript Research Studies GOTCHA’S

Research Studies
GOTCHA’S
By Sally Duffy
Failure to follow protocol, investigator
agreements and regulations
• Did not use device/drug in manner specified in
protocol
• Follow-up exams and tests were not performed
• SAEs and complications were not reported to
IRB as required by protocol and IRB
• Delegated tasks to unqualified individuals
• Enrolled subjects do not appear to have met
eligibility criteria
• Failed to report to IRB unanticipated problems
involving risk to human subjects
Failure to Maintain Complete and
Accurate Subject Records
• 21CFR 812.140(a)
• No source to support data
• Date discrepancies for tests, administration of
study drug
• Inconsistent weights
• CRFs do not include information about
medications used by subject
• CRFs incomplete...pages not signed and dated
• Incorrect serial/model numbers used
Failure to Report to IRB
• 21CFR 812.110(b) and 812.150(1)
• SAE reports given to the FDA and IRB did not
match
• Subject hospitalized and died, however, there is
no documentation indicating prompt reporting to
IRB
• UADEs not reported within 10 working days of
hearing about event
• Did not meet IRB’s requirements for notification
within three business days of becoming aware of
SAE
Assessing your practice:
Failure to follow the protocol,
investigator agreement or regulations
• Protocol deviations, with or without sponsor waivers, are
reportable deviations
• Be familiar with protocol requirements.
– Print Inclusion/exclusion criteria and evaluate
carefully; use as enrollment checklist.
– Print study visit schedules and ensure they are
followed. Place in front of subject binder and check
off at each visit.
– Coordinate appointments with other departments
Assessing your practice:
Failure to follow the protocol,
investigator agreement or regulations
• When protocol deviations are discovered consider a
Root Cause analysis and a Corrective and
Preventive Action (CAPA) Plan
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Evaluate WHY deviation occurred
Determine where else it could have occurred
Develop and document plan to prevent recurrence
Report deviations as required
Monitor performance to ensure corrective actions are
effective in preventing recurrence
Failure to Maintain Accurate Source
Documentation
• CRF data points must be supported in
source documents unless specified
otherwise in protocol
• Source document worksheets may be created to
capture data not normally recorded elsewhere
• CAUTION: If worksheets are used there is a
potential for conflicting source data due to
capture of redundant data
• ALWAYS know where the data is first recorded
Assess your Practice
• Protocol normally defines reporting timelines
to the Sponsor
• SAEs, UADEs and protocol deviations to protect
life or physical well-being of a subject in an
emergency are normally most urgent.
• Each IRB has its own policies and
procedures
– Obtain and understand the SOPs/policies of your IRB.
IRBs are required to have written policies
Assessing your Practice
• Essential to follow through to resolution any
outstanding issues/queries
– Question recurring issues
– Implement corrective actions to prevent recurrence
• Presentation of source documentation is critical
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– Patient eligibility requirements as stated in the clinical
protocol
– Study endpoints
– Adverse event details