General Purpose
to help quality (to maintain quality at present)
to assure quality (make sure that quality in future is maintained)
Purpose of sponsor audits
ensure that sponsor meets regulatory and GCP requirements
ensure that SOPs are followed ensure that the Investigator is following the
protocol ensure that the Investigator meets regulatory
and GCP requirements
Auditors
are independent of and seperate from routine monitoring and quality control functions
qualified by training and exprience qualifications should be documented
What type of audit?
CRO
Investigator site
Systems(AE reporting)
Trial report
Sponsor
Database
Audits
General Criteria for audits
importance of trial to regulatory submission number of subjects in trial type and complexity of the trial level of risks to trial subjects indentified problems
Which centers?
random selection high recruiters low recruiters for cause preapare for regulatory inspection
When to audit an investigator site? before recruitment after recruitment during recruitment during follow-up after study has completed
Timetable
letter (including sites selected for audit) in-house general study file audit in-house investigator file audit pre-field audit discussions with monitor field audit field audit discussions with monitor field audit discussions with investigator,study staff
and monitor audit report follow-up action as appropriate
What auditors look for?
1. a complete, legible,visible and robust data trail
2. the requirements of GCP are being met
Top ten audit findings
informed consent (not all elements 53%) non-adherance to protocol 30% source documents and CRF entries
(inadequate/inaccurate record 25%) drug accountability (inadequate accountability 20%) IRB documentation (problems 12%) documentation and filling patient compliance AE reporting SAE reporting laboratory documentation
Specific audit findings
Documentation and filling inadequate miss-filling
Informed consent patient’s signature not dated personally incorrect version of form used form not signed by the patient prior to study-
related procedures performed back dated signatures on form
Specific audit findings
Drug accountability irregular inventory incomplete or missing receipts not signed by sites CRFs not up to date
Laboratory certification of accreditation methodology description
What happens after audit?
sponsor and investigator responsible for auctioning recommendations
audit report to be filed (where) audit certificate (who)
Benefits
reassurance opportunities to learn and raise standarts opportunities for process improvement helps keep us on course for regulatory/gcp compliance helps maintain same standarts of quality across different
projects(countries) reduces possibility of delays in licensing and marketing of a drug highlights areas where we need to take corrective actions highlights training needs
Your site is being audited!!!!!
site contacted from goverment, regulatory authority, sponsor or cro or you are notified before the site is notified
verify and ensure regulatory department and project team is aware
rewiew of in-house files- obtain any deficient documents
review site’s regulatory binder-at site or over phone with site personnel
ensure any follow-up items from monitoring reports are completed