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Medical Alley Advanced Monitoring Workshop. Paul Below P. Below Consulting, Inc. October 19, 2005. Disclosure. The presenter does not have a significant equity interest in any of the companies/products referenced here The presenter has a consulting relationship with the following:

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Medical alley advanced monitoring workshop l.jpg

Medical Alley Advanced Monitoring Workshop

Paul Below

P. Below Consulting, Inc.

October 19, 2005

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  • The presenter does not have a significant equity interest in any of the companies/products referenced here

  • The presenter has a consulting relationship with the following:

    • GlaxoSmithKline

    • Boehringer Ingelheim Pharmaceuticals

    • Southeast Louisiana Chapter ACRP

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This presentation and related references are posted on my website at:

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  • The role of monitoring in Good Clinical Practices (GCPs)

  • Activities involved in on-site visits

  • Common site problems and findings

  • Addressing non-compliance

  • Fraud and misconduct

  • Electronic records

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  • Interactive case studies of real-life monitoring situations

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The Role of Monitoring in Good Clinical Practices

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Why Do We Monitor?

  • Required to by regulation

  • Ensure the acceptance of trial data by regulatory authorities (i.e., FDA)

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Why Do We Monitor?

  • Verify that rights and well-being of human subjects are protected

  • Verify that reported data are accurate, complete and verifiable

  • Verify trial is conducted in compliance with protocol, GCP and applicable regulatory requirements

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Good Clinical Practice

  • “A unified standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects”

  • Federal regulations (Title 21 CFR)

  • Other federal regulations & state laws

  • FDA “guidance documents”

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GCP Regulations

  • Protection of human subjects - informed consent (part 50)

  • Institutional review boards (part 56)

  • Financial disclosure (part 54)

  • Electronics records and signatures (part 11)

  • Investigational new drugs (part 312) and application to market a new drug (part 314)

  • Investigational device exemptions (part 812) & premarket approval of medical devices (part 814)

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Other Federal Regulations

  • Nuclear Regulatory Commission regulations (10 CFR 35) for the medical use of radioactive substances

  • Department of Transportation regulations for the shipment of infectious materials (49 CFR)

  • HIPAA Privacy Rule (45 CFR 160-164) for the use and disclosure of protected health information

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State Laws

  • Many states have laws that impact clinical research in the following areas:

    • Age of consent

    • Legally authorized representative

    • Clinical research registration

    • Medical records privacy

    • Gene research

    • STD/HIV reporting

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GCP Guidance Documents

  • FDA Information Sheets (

  • Guideline for the Monitoring Clinical Investigations (January 1988)

  • ICH Guidelines for Good Clinical Practice (Published in Federal Register - May 9, 1997)

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FDA Guidance

  • Represents the agency’s “current thinking” on how to comply with the regulations

  • Not legally binding

  • Non-compliance should not be cited in a FDA Form 483

  • An alternative approach can be used if acceptable to FDA

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What is ICH?

  • International Conference on the Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use

  • Comprised of representatives from the U.S., European Union and Japan

  • Establish guidelines to promote mutual acceptance of data

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Monitoring Requirement

  • “Sponsors are responsible for … ensuring proper monitoring of the investigation” (812.40 and 312.50)

  • “The sponsor shall monitor the progress of all investigations involving an exception to informed consent” (812.47 and 312.54)

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Monitoring Plan

  • For significant risk device and treatment use trials, FDA requires written procedures for monitoring in the investigational plan (812.25, 812.40)

  • FDA can withhold or pull approval of an application if the monitoring plan is inadequate (812.30)

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Monitoring Plan (cont)

  • Monitoring plan based on:

    • Trial objectives, design, endpoints

    • Trial complexity

    • Number/location of investigators

    • Type of investigational product

    • Disease under study

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Type of Monitoring

  • “Personal contact” should be maintained with the investigator throughout the trial

  • Need for on-site visits before, during and after the trial

  • In exceptional circumstances, central monitoring can be used

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Selection of Monitors

  • “A sponsor shall select monitors qualified by training and experience” (812.43)

  • A list of names and addresses of all monitors is included with the investigational plan (812.25)

  • Monitoring functions can be transferred to a CRO (312.52)

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Monitor Selection

  • Need not be qualified to diagnose or treat disease under study

  • Thoroughly familiar with test article, protocol and informed consent, sponsor’s SOPs, and GCPs and FDA regulations

  • Qualifications should be documented

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Recent FDA Warning Letter

“Study monitors were not qualified by training and experience. Neither of the two individuals who conducted monitoring visits for the [redacted] study had previous experience in clinical monitoring; one of the two monitors had no training in clinical trials prior to conducting independent monitoring trials.”

CDRH Warning Letter to Celsion Corporation (May 7, 2004)

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Outstanding Monitor Traits

  • Quick scientific learners

  • Independent problem solvers

  • Can hack the travel

  • Can see the forest and the trees

  • Regulatory experts

  • Technologically proficient

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Activities Involvedin On-Site Visits

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On-Site Visit Types

  • Pre-Investigation

  • Periodic Monitoring

  • Close-Out

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Selection of Investigators

  • “A sponsor shall select investigators qualified by training and experience to investigate the device” (812.43)

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Investigator Selection

  • Preliminary phone contacts and on-site visit to determine if the investigator:

    • Understands and accepts trial obligations

    • Understands and accepts regulatory obligations

    • Can demonstrate potential for recruitment based on retrospective data

    • Has adequate facilities

    • Has sufficient time

    • Has adequate number of qualified staff for duration of trial

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Investigator Selection

  • Other Considerations:

    • Past company performance

    • Past performance with other sponsors

    • References from colleagues

    • Publication record

    • Key opinion leaders

    • FDA Debarment and Disqualified Lists

    • FDA Warning Letters

    • CDER Clinical Investigator Inspection List

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FDA Investigator Lists

  • Debarment List:

    • Convicted of a felony under Federal law for conduct relating to development or approval of any drug product


  • Disqualified/Restricted/Assurances Lists:

    • Disqualified through hearing process or restricted through consent agreement


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FDA Investigator Lists

  • Clinical Investigators Inspection List:

    • Contains information gathered from inspections of clinical investigators who have performed studies with investigational human drugs

    • The inspections were conducted as part of FDA’s Bioresearch Monitoring Program


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Pre-Investigation Visit

  • Location

    • All facilities where trial conduct will occur

  • Materials

    • Investigator’s Manual

    • Device

    • Agenda

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Pre-Investigation Visit

  • Participants

    • Principal Investigator/Co-Investigators

    • Study coordinator/research nurse

    • Other medical staff (technicians)

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Pre-Investigation Activities

  • Discussion of device background, protocol procedures

  • Discussion of resources

    • Staff availability and training

    • Adequate time and workload

    • Interest and motivation level

    • Available patients (review retrospective data)

    • Competing trials

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Pre-Investigation Activities

  • Review case report forms and required source documentation

  • Discussion of regulatory obligations

    • IRB review

    • Informed consent

    • Record keeping

    • Investigational product

    • Company policies and procedures

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Pre-Investigation Activities

  • Tour facilities

    • Patient evaluation and treatment facilities

    • Emergency facilities and staff

    • Laboratory

    • Device storage and security

    • Files storage (administrative and patient)

  • Collect investigator documentation

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Investigator Documentation

  • CV and/or statement of relevant experience (812.43)

  • If involved in a terminated trial, explanation of circumstances (812.43)

  • Signed Investigator Agreement (812.43)

  • Financial disclosure information (812.43)

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Investigator Documentation

  • IRB approval documentation (812.42)

  • Provide the investigator with the investigational plan and report of prior investigations of the device (812.45)

  • Other records (ICH):

    • Local lab certification, normal ranges

    • IRB membership roster

    • Medical license

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Periodic Visit Planning

  • Participants

    • Study coordinator

    • Principal investigator

    • Technicians

  • Timing

    • Follow monitoring plan

    • Flexibility for problem sites

    • First visit early

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Periodic Visit Planning

  • Materials

    • Protocol

    • List of enrolled patients

    • Reference manuals

    • Site specific material/documents

    • Office supplies

  • Assigned work space

  • Assigned time with investigator and trial staff

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Periodic Visit Objectives

  • Review compliance with protocol, GCPs, and sponsor SOPs

  • Review data

  • Review investigational product

  • Verify adequacy of facilities & resources

  • Review essential (regulatory) documents

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Protocol/GCP Compliance

  • Protocol deviations explained (812.140)

  • Enrolling only eligible patients

  • Informed consent obtained before each subject’s trial participation (and case history statement, 812.140)

  • All required reports to sponsor and IRB

  • Adverse events appropriately reported

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Data Review

  • Source data are accurate, complete, and up-to-date

  • Compare accuracy and completeness of CRF entries to source data

  • Visits not done and tests not conducted clearly reported as such on CRF

  • All withdrawals and dropouts are reported and explained on the CRFs

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Data Review (cont)

  • Ensure appropriate CRF corrections are made, initiated, dated and explained (if necessary)

  • Member of trial staff authorized by investigator to make corrections should be documented

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CRF Review

  • First Pass

    • All pages present

    • Headers complete and accurate

    • Missing fields flagged

  • Primary Review

    • All applicable data cross-checked with source documentation

    • Concomitant medications are spelled correctly and have correct dosage

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CRF Review (cont)

  • Compliance Review

    • Visits within protocol-defined window

    • All procedures done

    • Adequate explanations for protocol deviations

    • Evidence of PI involvement in the trial

    • Continuing adverse events followed-up

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CRF Review (cont)

  • Logic Check

    • Data is within the expected range

    • Medical history conditions and adverse events requiring treatments have concomitant medications listed

    • Redundant CRF fields are consistent with each other

    • Primary efficacy response follows an expected pattern

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Investigational Product

  • Storage conditions acceptable

  • Supplied only to eligible patients

  • Receipt, use and return are controlled and documented (812.140)

  • Exposure of each subject to the device is documented (date and time of each use, 812.140)

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Facilities and Resources

  • Ensure investigator and trial staff are adequately informed about the trial

  • Investigator and trial staff are performing specified trial functions (not delegated to unauthorized persons)

  • Reporting subject recruitment rate

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Close-Out Visit Activities

  • IRB notified of trial closure

  • Final device reconciliation, return or disposal performed

  • All CRFs submitted and final data queries resolved

  • Subject study files are complete

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Close-Out Visit Activities

  • Regulatory and administrative study files are complete

  • Record retention period discussed:

    • Accessible to FDA and Sponsor

    • Minimum of 2 years after the date the investigation is terminated or completed or the date the records are no longer needed to support a PMA (812.140)

    • Records custody can be transferred in writing - FDA notified in 10 days (812.140)

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Monitor Report

  • Should submit a written report to the sponsor after each trial-site visit or trial-related communication

  • Include date, site, monitor name, name of investigator and/or other staff contacted

  • Include summary of what was reviewed

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Monitor Report

  • Also includes the following items:

    • Significant findings

    • Deviations and deficiencies

    • Conclusions

    • Actions taken or to be taken

    • Actions recommended to secure compliance

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Recent FDA Warning Letter

“There were no existing Standard Operating Procedures for the internal review and investigation of deficiencies identified through the field clinical monitoring reports.”

Source: CDRH Warning Letter to Cordis Corporation (July 7, 2004)

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Recent FDA Warning Letter

“Even though your monitor did not check the site device log during the March 13-14, 2001 site visit, in the visit report dated April 25, 2001, the monitor stated that the device accountability records at clinical site [redacted] of the [redacted] Study had been determined by the monitor to be accurate and complete.”

Source: CDRH Warning Letter to Boston Scientific Corporation (August 22, 2004)

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Warning Letter Citations on Monitoring (2003-04)

Source: Nancy Starks, Clinical Device Group

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Common Site Problems and Findings

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Site Audit Findings - CDRH

Source: ACRP Medical Device BIMO Workshop 2002 and MN ACRP Presentation 09/2004

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Site Audit Findings - CDER

Source: FDA - DIA 2000 and ACRP 2004

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2003 Audit Comparison

Device Drug (353)(368)

Protocol Deviations38%25%

Inadequate Consent21%9%

Inadequate InvestigationalProduct Accountability18%5%

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Common Site Problems

  • Slow/erratic enrollment or follow-up

  • Patients lost to follow-up

  • Protocol non-compliance

    • Enrollment of ineligible patients

    • Violation of visit schedule, treatment procedures, etc.

    • Required adjunctive procedures not performed or adequately documented

    • Disallowed concomitant therapy

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Common Site Problems

  • Data Problems . . .

    • Incomplete documentation of dropouts

    • Missing or incomplete date

    • Erroneous or inconsistent data

    • Errors in units recorded or conversion of units

    • Discrepancies between data in CRF and source documents

    • Inadequate source documents

    • Corrections made incorrectly or not properly documented

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Common Site Problems

  • Data Problems . . .

    • Abnormal values not documented

    • Inter-current illnesses and/or concomitant drugs not documented

    • Complications/adverse events not properly documented

  • Device/drug accountability incorrect or incomplete

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Addressing Non-Compliance

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“A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the requirements of this part or other applicable FDA regulations, or any conditions of approval imposed by the reviewing IRB or FDA shall promptly either secure compliance or discontinue shipments of the device to the investigator and terminate the investigators participation in the investigation.” (812.146)

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  • Repeated but minor non-compliance usually due to overwork, inexperience

  • Spend additional time on protocol and GCP training

  • Talk to staff supervisor and investigator about additional personnel resources

  • Bring a co-monitor for reinforcement

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  • If negligence or apathy on part of investigator, inform IRB and plan site closure unless improvement

  • If data integrity is compromised, withhold payment

  • Withdraw consideration for future trials

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Tools to Improve Conduct

  • Report visit findings in follow-up letter to investigator and study coordinator

  • Trial delegation authorization list

  • Protocol deviation/explanation list

  • File all relevant telephone contact reports at the site

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Tools (cont)

  • Study specific source documents

  • Annotated case report forms

  • Trial newsletter/website

  • Frequently asked questions document

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Detecting Fraud and Misconduct

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FDA Definition of Research Fraud

  • Research misconduct means falsification of data in proposing, designing, performing, recording, supervising or reviewing research, or in reporting research results.

  • The FDA uses the terms “fraud” and “misconduct” interchangeably

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Definition (cont)

  • Per FDA, falsification includes acts of omission and commission

  • Omission = consciously not revealing all data

  • Commission = consciously altering or fabricating data (eg, lab values, lesion counts, etc)

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Definition (cont)

  • Fraud does not include honest error or honest differences in opinion

  • Per the FDA, deliberate or repeated noncompliance with the protocol and GCP can be considered fraud, but is secondary to falsification of data

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Prevalence of Fraud

  • Difficult to determine but considered rare

  • Reported to significantly impact 1-5% of pharmaceutical clinical trials - Frank Wells, Medico Legal Investigations (Reuters Health, Jan 2002)

  • Only ~3% of FDA inspections uncover serious GCP violations

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Consequences of Fraud

  • Sponsor – data validity compromised, submission jeopardized, additional costs

  • Investigator – disqualification, fines, incarceration, legal expenses, ruined career

  • Institution – lawsuits

  • Subject – safety at risk, loss of trust in clinical trial process

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Consequences (cont)

  • Fraudulent investigators are often used by multiple sponsors on multiple trials

  • A small number of investigators can have a broad impact on many submissions made by sponsors

  • Disqualified investigator, Dr. Fiddes, was involved in 91 submissions with 47 different sponsors

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Why Does Fraud Occur?

  • Not enough time or staff

  • Not enough subjects

  • Lack of GCP training and/or regulatory oversight

  • Laziness, loss of interest

  • Money, greed

  • Pressure to perform, publish

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General Warning Signs

  • High staff turnover

  • Staff are disgruntled, fearful, anxious, depressed, defensive.

  • High pressure work environment

  • Obsession with study payments

  • Absent investigators

  • Lack of GCP training

  • Unusually fast recruitment

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Data Identifiers

  • Implausible trends/patterns:

    • 100% drug compliance

    • Perfect efficacy responses for all subjects

    • Identical lab/ECG results

    • No SAEs reported

    • Subjects adhering perfectly to visit schedules

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Data Identifiers (cont)

  • Site data not consistent with other centers (statistical outlier)

  • Perfect diary cards, immaculate CRFs

  • All source records & CRFs completed with the same pen

  • Source records lack an audit trail - no signatures and dates of persons completing documentation

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Identifiers (cont)

  • Subject handwriting and signatures are inconsistent across documents (consents, diaries)

  • Questionable subject visit dates (Sundays, holidays, staff vacations)

  • Impossible events (eg, randomization before drug delivery)

  • Data contains “digit preference”

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Identifiers (cont)

  • Subject visits cannot be verified in the medical chart, appointment schedule, or billing records

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CRA Strategies for Detecting Fraud

  • Ask for all information (data) pertinent to the study (CRFs, study specific source worksheets, clinic charts, sign-in sheets, lab requisitions, shipping records)

  • Accept no copies – review originals whenever possible

  • Get technical – read lab reports, x-rays, ECGs – don’t just inventory

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Detection Strategies (cont)

  • Expect fraud – start from the assumption that records are bogus and work backwards

  • Question missing, altered, and/or inconsistent data – offer to retrieve records yourself, keep pulling on loose ends and see what unravels

  • Don’t be intimidated – challenge the site to explain suspicious data

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Detection Strategies (cont)

  • Be suspicious of blame shifting –remind the investigator that he/she is responsible for study conduct

  • Cultivate whistleblowers – pay attention to staff complaints, listen to grievances, establish rapport, and be approachable

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What Do I Do If I Detect Fraud?

  • Follow company SOPs

  • Carry out remainder of visit as usual

  • Collect supporting documentation

  • Call supervisor/study manager when you are away from the site

  • Challenge but do not accuse

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What Do I Do?

  • Write a fact-based summary of your findings when you return to the office

  • Call in independent auditors to confirm suspicions

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Electronic Records and Signatures

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  • Process started in 1991 - Pharma industry and FDA met to determine how to accommodate paperless record systems within the GMP regulations

  • Created Task Force on Electronic Identification and Signatures to develop a uniform approach to electronics records and signatures for all FDA program areas

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History (cont)

  • 1992 - FDA announced it was considering the use of electronic signatures and requested comments

  • 1994 - Proposed rule published and additional comments requested

  • Final rule effective August 20, 1997

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Importance to Industry

  • Electronic records prevalent across many manufacturing, laboratory and clinical practices

  • Benefits are enormous:

    • Increased speed of information exchange

    • Cost savings

    • Reduced errors

    • Improved process control

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Scope of the Final Rule

  • Provides criteria under which agency will consider electronic records and signatures equivalent to paper

  • Applies to any record required to be maintained or submitted to the agency

  • Computer systems and documentation maintained under this part are subject to FDA inspection - legacy systems are not exempt

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  • If requirements of the rule are met, electronics records & signatures can be used in lieu of paper and handwritten signatures in whole or in part

  • FDA has a list of documents that it can accept submitted in electronic form

  • Use of electronic records and their submission to FDA is voluntary

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  • Electronic record - any combination of text, graphics, data, audio, or pictorial information represented in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer

  • Electronic signature - a compilation of any symbol(s) executed to be the legally binding equivalent of an individual’s handwritten signature

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Definitions (cont)

  • FDA defines closed and open systems - difference is in who controls system

  • Closed system = people responsible for data content also control system

  • In an open system, data could reside for some period of time on a system that is outside the control of the organization that owns the data

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System Requirements

  • System must be “validated” to ensure accuracy, reliability and consistency

  • Ability to generate accurate and complete copies of records (readable form suitable for inspection)

  • Protection and ready retrieval of records throughout the archival period

  • Limited access to authorized individuals

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System Requirements (cont)

  • Use of audit trials (computer-generated, time-stamped) to record the creation, modification and deletion of records

  • Audit trial documentation must be retained and available for agency inspection

  • Persons using and maintaining systems are trained to perform their assigned tasks

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System Requirements (cont)

  • Establishment and enforcement of written policies that hold individuals responsible for actions initiated under their electronic signature

  • Systems documentation is controlled (access and distribution) and audit trial maintained for modifications

  • Encryption may be necessary for open systems to ensure confidentiality

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Signature Requirements

  • Signed electronic records need to have the following information:

    • Printed name of the signer

    • Date and time of signature

    • Meaning of the signature (i.e., review, approval, authorship)

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Signature Requirements (cont)

  • Electronic signature cannot be excised, copied or transferred

  • Unique to one individual (cannot reused or reassigned)

  • An organization must verify individual identity before an electronic signature is established and assigned

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Signature Requirements (cont)

  • Sponsors need to “certify” to FDA when electronic signatures will be used as the legally binding equivalent of handwritten signatures

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Signature Controls

  • Best control is based on biometrics

  • If not, at least two distinct components should be employed such an identification code and password.

  • Maintain uniqueness of combined identification code and password

  • Identification codes and passwords are periodically recalled or revised

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Signature Controls (cont)

  • Have a procedure for lost devices that generate ID codes

  • Periodically test ID devices

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Interactive Case Studies

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This presentation and related references are posted on my website at:

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Contact Information

  • E-mail:

  • Home office phone: (952) 882-4083

  • Don’t hesitate to call me with follow-up questions!

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