Recorded Webinars
Issues with Consent Documents
According to current statistics, more than 90 million people in the United States have a hard time understanding and using health information. This is as many people as there are in France, Belgium and the Netherlands. To respond to this growing needed, President Obama signed the Plain Writing Act of 2010 and two other executive orders to cover the use of plain language. Use of Plain Language gets researchers closer to the historically used 6th to 8th grade level as the target for written consent documents. There are other tips as well that can improve the readability and acceptably of a consent document.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
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The Sunshine Act: Reporting for Clinical Trials
The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
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Federalwide Assurance (FWA) for the Protection of Human Subjects
The Federal wide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. This document, signed by the Institutional Official, sets forth certain requirements that must be upheld by an institution who has filed such an agreement. One of the terms deals with written agreements for non-affiliated investigators and institutions.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
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FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Requirements
FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
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Investigational Device Accountability
Investigational device accountability is outlined in the FDA's regulations. Included in this topic is the receipt, storage, distribution, reconciliation, return and authorized destruction of investigational devices. Many industry sponsors already have standard operating procedures outline these policies but there are instances when a standard operating procedure or guideline does not already exist and those working with these devices need to know their responsibilities.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
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Differences between Device and Drug Clinical Research- A Jeopardy Learning Game
Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well current guidance affecting the classification of devices.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
- View Details
Serious Adverse Events (SAEs): What it is and How to Handle
When conducting clinical trials it is important to understand and be able to identify serious adverse events (SAE). These are events that are serious, likely related to the study drug, device, treatment or procedure, and increase risks to participants or others.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
- View Details
Clinical Trial Recruitment Methods and Metrics
Recruitment of research participants into clinical trials is critical. As the trials are designed for human subjects or use of a person's private identifiable information, a human subject's research study cannot occur with people. Yet, enrollment issues continue to be one of the reasons why trials are held open longer than anticipated and why modifications to the study are needed to increase enrollment.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
- View Details
Federalwide Assurance (FWA) for the Protection of Human Subjects
The Federal wide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. This document, signed by the Institutional Official, sets forth certain requirements that must be upheld by an institution who has filed such an agreement. One of the terms deals with written agreements for non-affiliated investigators and institutions.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
- View Details
Assessing Risk in Human Research Protocols
45 CFR 46.111 (a)(2) states, "In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research)." How the study is designed can minimize potential risks to participants. Studies that are deemed "minimal risk" have greater options when it comes to using an expedited review system and options for consent.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
- View Details
Serious Adverse Events (SAEs): What it is and How to Handle
When conducting clinical trials it is important to understand and be able to identify serious adverse events (SAE). These are events that are serious, likely related to the study drug, device, treatment or procedure, and increase risks to participants or others.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
- View Details
Clinical Trial Recruitment Methods and Metrics
Recruitment of research participants into clinical trials is critical. As the trials are designed for human subjects or use of a person's private identifiable information, a human subject's research study cannot occur with people. Yet, enrollment issues continue to be one of the reasons why trials are held open longer than anticipated and why modifications to the study are needed to increase enrollment.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
- View Details
Issues with Consent Documents
The consent document tends to be the source of much frustration for both research participants, research team members, and the IRB reviewers who must review and approve the document and process before it is implemented. Although the regulations default to a written consent document, consent is more than just a document, it is a process.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
- View Details
Assessing Risk in Human Research Protocols
45 CFR 46.111 (a)(2) states, "In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research)." How the study is designed can minimize potential risks to participants. Studies that are deemed "minimal risk" have greater options when it comes to using an expedited review system and options for consent.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤179.00
- View Details
Serious Adverse Events (SAEs): What it is and How to Handle
When conducting clinical trials it is important to understand and be able to identify serious adverse events (SAE). These are events that are serious, likely related to the study drug, device, treatment or procedure, and increase risks to participants or others.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤225.00
- View Details
Clinical Trial Recruitment Methods and Metrics
Recruitment of research participants into clinical trials is critical. As the trials are designed for human subjects or use of a person's private identifiable information, a human subject's research study cannot occur with people. Yet, enrollment issues continue to be one of the reasons why trials are held open longer than anticipated and why modifications to the study are needed to increase enrollment.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤225.00
- View Details
What is a Serious Adverse Events and how do I handle these?
When conducting clinical trials it is important to understand and be able to identify serious adverse events (SAE). These are events that are serious, likely related to the study drug, device, treatment or procedure, and increase risks to participants or others.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤225.00
- View Details
Issues with Consent Documents
The consent document tends to be the source of much frustration for both research participants, research team members, and the IRB reviewers who must review and approve the document and process before it is implemented. Although the regulations default to a written consent document, consent is more than just a document, it is a process.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤225.00
- View Details
Assurances: What are they, Why and When do I need them
The Federal wide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. This document, signed by the Institutional Official, sets forth certain requirements that must be upheld by an institution who has filed such an agreement. One of the terms deals with written agreements for non-affiliated investigators and institutions.
- Sarah Fowler-Dixon
- Recorded
- Price: ¤225.00
- View Details