Audit Ebru Mutlu-Omega CRO. General Purpose to help quality (to maintain quality at present) to assure quality (make sure that quality in future is maintained)

Audit

Ebru Mutlu-Omega CRO

General Purpose

to help quality (to maintain quality at present)

to assure quality (make sure that quality in future is maintained)

Who conduct audits?

Sponsor

Regulatory Authorities (FDA, EMEA or MOH )

If a clinical trial is being monitored what’s the point

of auditing it?

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

Which studies?

all?? pivotal phase II pivotal phase III CROs

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?

audit report is issued.Draft???

What happens after audit?

sponsor and investigator responsible for auctioning recommendations

audit report to be filed (where) audit certificate (who)

Regulatory inspections

FDA Between 1977-1994

3000 routine 650 for cause

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

Your monitoring has been per ICH/GCP’s and your company SOP’s.....

SO THERE IS NOTHING TO FEAR