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Tips for Successful Auditor/Monitor VisitsCRMO September 2015
Outline Objectives Role of Auditors/Monitors Explore auditing and monitoring
Differences between the visit types Purpose of visits
Common Deficiencies Preparation Response
Objectives Be familiar with difference between
auditing and monitoring Know what to expect during either an
audit or monitor visit Understand ways to prepare and
respond to auditing and monitoring visits
Role and Responsibilities: Auditor/Monitor Assure rights, safety and well being of
subjects are protected Review trial data for accuracy, verifiable Oversee study activities for protocol,
GCP and regulatory compliance
Monitoring vs AuditingMonitoring AuditingContinuous process Done either during the trial
or after the completion of trial
Controls quality of trial Assures quality of trialDone by monitor who is a part of trial
Done by independent personnel of trial
Monitor Visits:Type and Purpose
Purpose of Monitoring Visits Review progress of clinical trial and
ensure protocol adherence and regulatory compliance while maintaining the rights, safety, and well-being of subjects
Frequency of visits dictated by complexity and Sponsor requirements
Types of Monitor Visits Site Initiation Visit
Interim Monitoring Visit
Close Out Visit
Site Initiation Visit The purpose of this visit is to ensure the
study team is familiar and understands Protocol procedures CRF completion Drug handling requirements Adverse Event Reporting Patient recruitment resources
Identify potential problems and concerns
Interim Monitoring Visits Purpose of visit is to:
Review progress of study Ensure protocol adherence Assure data accuracy and patient safety Regulatory compliance
Occur at various frequency depending on sponsor requirements
Close Out Visit Purpose is to review:
All regulatory documents DARFs Review record retention guideline
Occurs when all subjects have completed the study and all necessary data has been collected
Audits: Type and Purpose
Purpose of Auditing Evaluate the trial conduct and
compliance with: Quality systems SOPs Protocol GCP & other applicable regulatory
requirements
Types of Audits 2 types
Sponsor audit of site Routine For cause
IRB audit
Sponsor Audit of Site Aim to assess:
Have subject’s rights and safety been maintained?
Company procedures satisfactorily implemented
Accurate, reliable and verifiable data has been obtained from the trial
Provides assurance to both the sponsor and investigator that if a regulatory inspection occurs, no major problems have remained undetected and unresolved
Routine vs For CauseRoutine For CauseTo ensure that a site is complying with Protocol, SOP, GCP, and applicable regulatory requirements
If the site is out of compliance and the sponsors want to either verify the problem or be reassured that no problem exists.
“study-oriented audit” “investigator- oriented audit”
IRB Audit To ensure ethical conduct of trial Ensure subjects enrolled are well
informed about the trial and enrolled through a proper informed consent procedure
Can be either for cause or routine
Preparing for Auditor/Monitor Visits
Be Prepared… Best preparation is to know and
understand regulations and GCP guidance documents
Review protocol and associated documents
Learn from monitoring visits Ask questions
…Be Prepared Review agenda or monitoring letter
Ensure all records and documentation will be available
Monitor letters- check for any long outstanding deficiencies Have issues from previous visit been
resolved?
Preparing for Monitoring/Auditing Visits Prepare regulatory files
Ensure DOA is up to date A copy should be kept in binder if out for
signature so monitor can review Training
exists for all staff on DOA Training for protocol amendments
CVs/MLs up to date Lab documents are up to date SAE reports
Preparing Cont. Current 1572 is filed All protocol and IB versions are filed FDFs for all investigators on 1572 IRB Approvals
Current stamped consents Current patient materials
Correspondence IMV letters Email Newsletters
Preparing Cont. Study documentation to have readily
available: Regulatory binder Original signed ICFs CRFs Source documentation
During Audit/Monitor Visit Respond to questions asked with simple,
honest, and complete answers Listen actively Don’t rely on memory alone “I don’t know; we will review and get back to
you by the end of the day” is an acceptable answer, if applicable
Deferring to and locating appropriate person to answer the question within a specified time frame is acceptable.
At the End of the Visit Audit
Exit interview to review observations and findings
Monitor Meet to share findings, answer questions,
and identify any corrections needed
Responding to Auditor/Monitor Reports
Audit/Monitor Reports Audits:
Findings are rated as critical, major, and minor May include recommendations
Monitor: Summary of what was reviewed & significant
findings/facts, deviations & deficiencies, actions to take/recommended to ensure compliance
Common Deficiencies Failure to follow investigational plan Protocol deviations Inadequate recordkeeping Inadequate IP accountability Inadequate Adverse Event reporting Inadequate subject protection (includes
IFC issues)
Response to Findings… Answer queries or clarifications
May be done during the visit, but don’t need to correct all findings prior to monitor/auditor’s departure from site
Follow up with monitor to provide any documents or corrections to address issues on report
…Response to Findings When a mistake or incident of non-
compliance occurs, evaluate why What was the actual mistake? Under what circumstances did it occur? Who was involved? When was the error detected and how? What were the consequences?
Responding to Audit: CAP CAPA Answers should be S.M.A.R.T.
Specific, Measurable, Attainable, Relevant, Time-bound/Trackable
Be clear and precise Back up statements with fact (documents,
data)
Notes to File Effective NTFs correct, clarify, or add to
the existing source documentation and are: Well-written Relevant Infrequent Timely
Questions
References ICH GCP guidelines E6 www.fda.gov.in ICH 5.1.8.4 21 CFR 312 21 CFR 56