Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton Baltimore - BWI Airport
**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
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.
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.
|1||2 Attendees||10% off|
|2||3 to 6 Attendees||20% off|
|3||7 to 10 Attendees||25% off|
|4||10+ Attendees||30% off|
To avail the above group discounts, all the participants should register by making a single payment
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