TITLE REGULATORY COMPLIANCE FRAUD & MISCONDUCT PREPARATION FOR FDA INSPECTION

Dr. Shiva Murthy N.MBBS, MD, MBA, CEIM. Head, Clinical Pharmacology Unit A CRO in New Delhi Area shivuindia@yahoo.com
This presentation is only for education purpose only. Not for commercial sale.

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Primary
Make the advanced treatment available for patients. National or international geographic area to be covered Reduce the timelines to submit the data Collect information and compile systematically Submit to regulatory agencies Get marketing authorization

Secondary
Publish the articles Spread knowledge Increase clinical skills etc
compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Clinical research regulated by Drugs and Cosmetic Act 1940and its amendments Schedule Y and its revisions CDSCO recommendations/Notices Committees/Ministries/Supreme Court/Parliament Gazette Notifications ICMR ethics guidelines Indian GCP Other guidelines released time to time Expert review committees Apex committee and subject specific committees Media/Social interested groups Helsinki declaration International guidelines as per country specific targeted research project compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

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ICH guidelines - most important 4 Types - Efficacy - Quality - Safety - Multidisciplinary

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

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compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

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compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

For earning Money sponsors pressure For getting Famous eager to grow faster/become public figure For getting Govt recognition For getting Promotion For getting further Grants for their work For having Social positions like chief of institutions/burocrat etc
compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Definition of Research Misconduct Research misconduct means Fabrication, Falsification, or Plagiarism in Proposing, Performing, Or Reviewing Research, Or In Reporting Research results. Sever form of misconduct is considered as Fraud

(a) Fabrication is making up data or results and recording or reporting them. (b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. (c) Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. (d) Research misconduct does not include honest error or differences of opinion
compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Under-reporting of research Is another form of misconduct, given that this can lead to Seriously misleading recommendations for clinical practice and for new research.

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Fraud / misconduct should not happen in research In the real world all workers are not honest

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Obvious that results are opposite to other workers A patter or trend is followed False representation of visits where no visits happened Copying and replacing original data Cloning of data of one patient creating many patients data Non existence of supporting documents
compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Involvement of multiple parties Independent departments to monitor the work Regular check of data by Clinical research associates Regular checks by Quality Assurance auditors Regular check by sponsor monitor Internal quality control department checks Proper storage of the data
compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

If data is missing Reasons for missing - Incidence of burn/earth quick/other natural calamities
You should have back up plans and disaster management policies

No patient visit data or patients are not traceable No rejections all screened volunteers entered to study More number of studies in short period of time Simultaneously same indication studies for multiple sponsors Large number of staff turnover can be significant indicator
compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Separate pages made for hospital notes Separate folders for GP notes Can't find things will send later Notes/labs/drugs
One pen used throughout

But beware the eccentric!

Marks on visual analogue scales Clean diary cards

No coffee/curry/dog tooth marks

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Spotless CRFs Difficulty in arranging meetings Differences from other sites

Faster recruitment Fewer adverse events Fewer withdrawals

Odd hours worked Odd days of week/month worked

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Staff or insiders may complain to the regulatory agencies Suitable protection given by the regulators for these Regulators may recruit to find out facts Laws my emerge soon in India
(in US already available)
compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Identify the patients participated Store the case sheets separately easily traceable and producible if asked. Check all the data and ensure that all pages available ICH GCP
Essential documents list Most important See the slides given at the end of this presentation
compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Answer to the point Do not volunteer to give more information Show only what has been asked No need to be panic Speak clearly Listen carefully before speaking No gossiping/cross talking behind the inspector No mobile phones inside the inspection room No gossiping in the toilets
usual place to discuss all secrets

Speak confidently
compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Auditors will book their own hotels and transportation If asked to help same can be provided Food and drinks As requested by auditor to be provided Make them comfortable by providing fax, printer, computer if requested Only limited access to computer folders provide fresh / cleaned computer if requested Internet connection to be provided Do not volunteer to offer trips/bribes
This can spoil the future
compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Check before handing over any documents Copies may be provided to auditor to carry with them if requested
mark as uncontrolled copies and not to be copied with original seal.

Quality auditor to facilitate the audit Clinical researcher need not face auditor directly Read and be ready with procedure if asked to explain Be through with
what was done how the research work was done

Inform all the team members to be ready to answer if any questions / interviews
compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Keep your facility clean and neat Ensure that all loose points are addressed Ensure that all designated areas are labeled Ensure that clear working instructions/ procedures available

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Thank you

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com