2-day In-person Seminar

Designing and Monitoring Approvable Medical Device (cardiovascular) Protocols

February 4th & 5th 2016

Time: 9:00 AM to 6:00 PM

Baltimore, MD

Venue: DoubleTree by Hilton Baltimore - BWI Airport

Director : Charlene M. Jett
  Price: $1,495.00
(Seminar Fee for One Delegate)

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**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

Course "Designing and Monitoring Approvable Medical Device (cardiovascular) Protocols" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Construction of an approvable clinical trial protocol requires, excellent scientific writing and organization skills. Also paramount is gathering necessary information to manage the statistical analysis and data management of the study. This usually starts with a literature review, establishing key efficacy and safety parameters and determining proper sample size. Sample size calculations are a very important aspect of clinical trials, as are the consent and data collection forms, therefore the statistics and data management departments must be included for their input into the protocol and timelines.

An initial input, draft review and final protocol review meeting of all concerned departments should also include labeling, manufacturing, quality, regulatory, project management. It is also a good idea to get individual investigators input into the protocol design and data collection forms. At this point they can also create a draft budget for their participation. Once all input has been gathered the sponsor approval process can proceed. Once the sponsor has approved the protocol, all relevant IRBs must approve the protocol. The FDA must be sent a copy of the protocol and if critical feedback isn't received in 30 days, the study can go forward. This entire protocol writing process can take many months, data management, statistics, regulatory and project management all must create a plan for each protocol.

Once the final protocol is approved by everyone the CRAs, monitors , and CROs must be trained. This can take days or weeks depending on experience and expertise. The final package required for a good solid monitoring team to follow, should consist of an approved protocol, consent forms, data collection forms, listing of all intended principle investigators and contacts, all necessary IRB information. Excellent tracking and communications is imperative. All communication with investigator sites must be documented, as all communications with IRBs and FDA. Generally speaking the monitor is the focus for each site unless problems arise that require sponsor medical input.

Monitoring must be performed and 100% data checking done unless other arrangements have been made and agreed upon. My preferences is for 100% data checking, and it is very important for first time in man studies. All adverse events must be tracked on the case report forms for each patient and all serious adverse events and deaths must be tracked on the patients case report forms as well as tracked separately. The sites are not expected to communicate with the FDA for routine study management. Only if very serious unresolved persistent study management problems, adverse events or deaths occur, does the site communicate with FDA. The sponsor must be informed prior to any communication with the FDA.

The best outcomes are usually tied to a very well constructed protocol and a detailed budget from each prospective site. CRAs and monitors must be included as the focus point for budget negotiations and investigator payments. This necessitates the determination of evaluable and non- evaluable patients prior to payments. Evaluable means all the testing on the patients was completed per protocol and is valid. Sponsors are only expected to pay for evaluable patients data. All data corrections must be made prior to the database being finalized, locked/closed. Data analysis can only proceed after the database is locked. A statistical report on all data is required and must accompany or be part of a complete medical summary sent to the FDA, IRBs and investigators. If the study is stopped for any reason and not completed no statistical report is required, but all participants must be notified and told the rationale for stopping the study, this includes IRBs and FDA.

Monitoring is divided in to pre-study site evaluations, initial site visit, regular site visits and close out visits. Monitors must write complete and accurate trip reports for each site and each trip. Identification of patients and enrollment must be tracked. Similarly each patient must be tracked through the protocol, accounting for each device and each test done. Spreadsheets, grids, tables etc are extremely useful for this. It is VITAL that problems at each site be identified, and the action taken to correct the problem be put forth in the trip reports. Ongoing monitoring and documentation of steps to solve problems is required and must be identified to the medical monitor/director. Some investigators may request a copy of findings from the monitors before they leave the sites. Monitors must review in person with site coordinators and investigators, if necessary, all their findings.

Audits by FDA of sponsors, sites, and IRBs are all a possibility, therefore it is good to have a quality assurance review prior to each submission to FDA. This is usually a continuous process, but can be painful if the quality isn't built in to the design and monitoring of a protocol.

In conclusion, the design and monitoring of approvable medical device protocols is imperative to the ongoing development and new invention of medical devices. The focus on quality and improved health as institutional goals is necessary for anyone involved in human experimentation.

Why should you attend:

This seminar should be attended to ensure the proper compliance and development of traditional and new cardiovascular medical devices. Failure to attend could result in poorly managed clinical trials, wasted financial resources and liability based law suits. The development of well-designed clinical trials and rigorous monitoring is required. From the literature review to the last appendix, a protocol is THE tool required to be approved by IRBs, FDA and the sponsor/developer of the device. Monitoring according to GCP guidelines is required to determine evaluable patients. The more mistakes that are made the higher the cost. It takes 10 times as much time and money to fix mistakes/errors and misunderstandings as it does to do it right from the beginning. It requires significant training, resources and extraordinary diligence, planning and execution to design a cardiovascular device protocol and successfully monitor it.

Driving the protocol development and subsequent monitoring is on the project management critical path of any device under development. It must be thoroughly and completely understood, down to the last comma. Similarly the accompanying monitoring of the protocol, must be completed in an efficient, most forth right manner, to ensure viable data and statistical analysis. The documentation of these efforts by not only the sponsor but by all investigators and staff involved is tremendous. Training of all individuals and monitors must be flawless yet very efficient since this is a very competitive field. In addition, the IRBs and FDA will expect nothing short of perfection.

Clear direction and excellent communication are required to achieve the approval of these devices. The proper balance of pushing forward and yet addressing all safety considerations is paramount. Many bottlenecks can be prevented by a determined project manager and medical director who understand how to manage people and projects. Honest assessments of costs in development and monitoring are important to reach the market and significantly improve health.

Who will benefit:

  • Scientists
  • Nurses
  • Pharmacists
  • Clinical Research Associates (CRAs)
  • Medical Monitors
  • Medical Directors
  • Statisticians
  • Project Managers
  • Quality
  • Regulatory
  • Manufacturing and Labeling
  • Administration

Day 1 Schedule

Lecture 1:
  • Medical devices and purpose of testing and experimentation
  • Regulations and project management
  • Organizations: people and processes

Lecture 2:

Lecture 3:
  • Training by sponsor of staff
  • Training of sites and staff
  • Tracking

Lecture 4:

Day 2 Schedule

Lecture 1:
  • Data based management, queries and errors
  • Statistical analysis and reports
  • Medical Summaries

Lecture 2:
  • Overviews
  • Combined Summaries
  • Questions

Lecture 3:
  • Technology
  • Security
  • Bottlenecks

Lecture 4:
  • Expectations
  • Legal
  • Questions
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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

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Charlene M. Jett

President- 3R's Management Consulting and Therapeutics Inc

Charlene M. Jett is currently President of 3R's Management Consulting and Therapeutics, Inc. She has provided clinical research, regulatory and quality services to the pharmaceutical, medical device, diagnostic and chemical industries. This has encompassed over 30 different companies in 20 years. Charlene was employed by G.D. Searle and Abbott Laboratories for about 17 years. She achieved the positions of Sr. Research Biochemist , Sr. Clinical Research Associate (CRA) and Project Manager. She has worked in the specialties of cardiology, anesthesiology and surgery, anti-infective, rheumatology and cancer, plus others. She has written numerous protocols, consents, monitored clinical trials, written literature reviews, and medical summaries. She has created several publications and presentations. She has also taught graduate statistics and ethics; was a caregiver for her mother. Charlene obtained her BS in Physiology(Pre-Med) from the University of Illinois, MS in Biology from Northeastern Illinois University and another MS from Lake Forest Graduate School of Management. She currently is a member of Sigma Xi and the American Chemical Society, where she enjoys their many webinars.

Location: Baltimore, MD Hotel: DoubleTree by Hilton Baltimore - BWI Airport   890 Elkridge Landing Road, Linthicum, MD 21090 Ph - 410-859-8400

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