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 (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 (b) and (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 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 –Patient eligibility requirements as stated in the clinical protocol –Study endpoints –Adverse event details