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Whether exploring a promising new therapy, developing a pioneering technology, or just helping people live longer healthier lives, scientific research is an essential part of our success as a company. This course will look at the different types of research we support and will explain how laws and regulations, along with our own internal policies and procedures, have been put in place to protect the integrity of this research. It will also provide you with some practical advice on how to ensure that we continue doing research not only in the right way, but also for the right reasons. |
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Upon completion of this course, you will be able to:
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The icons at the top of the screen provide one-click access to key resources:
In addition, you can use the Audio icon to turn the audio on or off and the Exit icon to close the course window. |
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There are several features to help guide you through the course:
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Knowledge Check Once you have reviewed the content of this course, you will be required to complete a 10-question Knowledge Check. The Knowledge Check can be taken at any time by clicking the Table of Contents icon and selecting Knowledge Check. |
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Development of products that help people live longer and healthier lives is a long and complex process. In this section, we will explain why we conduct research, and outline the different kinds and levels of scientific research we support. |
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Scientific research helps us determine if a product is effective. In other words, it tells us if a product works. And if it does work, how well. |
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Scientific research provides us with the evidence that is required for regulatory approvals and market access decisions around the world. It serves as the basis for promotional claims once a product is approved. |
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Scientific research helps us to gain knowledge about product safety both before and after we launch a product. It helps to answer the question: is the product safer than what’s currently available on the market? And if so, for whom, how much, etc.? |
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Scientific research answers many other questions as well. In doing so, it helps us to produce products that are not only safe and effective, but also:
As we make our way through this course, you will learn more about the benefits of scientific research, and more importantly, about the role each of us has to play in safeguarding its integrity. |
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There are many different kinds and levels of scientific research that Abbott supports. Generally, this research breaks down into two broad categories: company-sponsored trials and investigator-initiated trials. |
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Company-sponsored Trials are studies that are designed and managed by Abbott. These studies typically include one or more participating medical centers (institutions), with properly qualified physicians or other healthcare professionals (investigators) administering the study. |
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Before a new product is approved for treatment or use, Abbott conducts a trial or series of trials to prove that the product is safe and effective, and to ultimately understand the extent of effectiveness. These trials are often referred to as investigational or pre-marketing/pre-approval clinical trials (also sometimes referred to as Phase I, II, or III trials). They generally provide the evidence to support regulatory approvals required to market our products in jurisdictions around the world. |
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Once a product or treatment is approved, Abbott sometimes conducts additional research. This research is commonly referred to as post-approval observational or post-marketing, or Phase IV trials. Its aim is to help us better understand longer-terms effects or performance of the product. These trials are sometimes even required as a condition of product approval. |
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What is most important to understand is that while there may be third-party institutions and investigators participating in the conduct of clinical trials, Abbott is responsible for company-sponsored trials. |
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Investigator-initiated Studies (IIS)/Investigator Sponsored Studies (ISS) are studies that are initiated, designed, and conducted by external investigators and institutions. That is to say, the investigator or institutional sponsors are responsible for the conduct of such studies. |
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IIS/ISS studies can include, for example:
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In some cases, Abbott may choose to provide funding and/or other support for Investigator-initiated or Sponsored Studies. For example, the Company may provide Abbott product to be used in an IIS. |
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However, it is important to keep in mind that as we are not the study sponsor and are not responsible for conduct of the IIS/ISS, our involvement is generally limited:
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Limiting our involvement in the conduct of IIS/ISS is necessary so there’s no misunderstanding around who is responsible for the study, and to help maintain the integrity and independence of the study results. However, as we will see later, there are a number of things we need to do in order to ensure our compliance with the rules and regulations governing IIS/ISS. |
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We conduct research to help us produce products that are not only safe and effective, but also easier to use, more cost effective, and more reliable. Company-sponsored trials Company-sponsored Trials are studies that are designed and managed by Abbott. These studies include:
Investigator-Initiated Studies (IIS)/Investigator-Sponsored Studies (ISS) Investigator-initiated Studies (IIS)/Investigator Sponsored Studies (ISS) are studies that are initiated, designed, and conducted by external investigators and institutions. As Abbott is not the study sponsor, our involvement is generally limited:
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Abbott is committed to ensuring objectivity in research, protecting research participants, and guaranteeing timely and transparent disclosure of study results. In this section, we will look at what is being done to ensure that our research activities remain focused on the legitimate advancement of science and free from inappropriate commercial influence. |
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Government agencies and regulatory authorities around the world set out laws, regulations, and standards governing many aspects of the research process from clinical trial design to the selection of investigators, from research funding to the timely reporting of meaningful study results. It is important to understand these requirements to ensure the research Abbott conducts aligns with all applicable laws, regulations, and standards. |
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In essence, the laws and regulations that govern scientific research can be broken down into two broad categories:
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The question of why we conduct or support research is of particular interest to regulators and government agencies. |
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Government agencies want to ensure that research funding is never used as a reward for buying, using, influencing the use of, or recommending our products, or as a means to promote an unapproved or off-label use of a product. |
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Activity: Scenario 27_C_28 |
Imagine . . . You work in Research and Development. You set up a robust post-marketing trial for the purpose of comparing the long-term safety of Abbott’s drug-alluding stents with that of a competitor’s. You recruit a group of highly qualified vascular surgeons (some of whom currently use Abbott stents and some who use a competitor’s technology) solely on the basis of their qualifications and expertise, and pay them fair market value compensation for their services. That's not correct! That's correct! That's partially correct! |
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Activity: Questions 29_C_28 |
Is there anything in this arrangement that you think might raise a red flag with government regulators? [1] Yes. [2] No. Submit |
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Activity: Feedback 28_C_28 |
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Activity: Scenario 30_C_29 |
Now imagine . . . You set up exactly the same trial: same endpoint, same group of doctors, same compensation. The only difference is that this time the trial is being driven by the Xience marketing group, who see it as a great opportunity to introduce their stents to a new group of doctors. That's not correct! That's correct! That's partially correct! |
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Activity: Questions 32_C_29 |
Do you think government regulators would still view this clinical trial as okay? [1] Yes. [2] No. Submit |
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Activity: Feedback 31_C_29 |
Even though on the surface it's the same exact trial – same endpoint, same group of doctors, same compensation – something fundamental has changed. What's changed is the reason why the research is being conducted. It is now clear that the real intent of the study isn’t to test the long-term safety of two technologies side-by-side, but rather to familiarize some of the vascular surgeons with Abbott’s stents. |
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Studies like this, where the intended objective is to introduce a new product or therapy to physicians, spur sales of the product, or reward physicians for using a product – rather than test a scientific hypothesis or collect data to fill a legitimate need – are often called “seeding” or “marketing” trials. Seeding trials could be considered illegal, if the payment is intended to reward or induce investigators to use or recommend a particular product. |
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In fact, any trial that is used for the purpose of improperly inducing or rewarding someone to use or recommend a company’s products, or to improve access to, or relationships with, health care professionals (HCPs) or investigators, may be considered illegal based on anti-corruption or anti-kickback laws. CLICK THE OTHER LAWS BUTTON TO LEARN MORE. |
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OTHER LAWS Other laws that target kickbacks and corrupt and fraudulent practices in the clinical research context, include:
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The bottom line is that it is illegal to make research payments or provide other items of value in order to improperly induce or reward investigators and HCPs to use or recommend the company’s products. |
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It is also illegal to conduct scientific research as a “disguised” means of promoting unapproved uses of Abbott products. For example, supporting a research study that has little or no scientific value in order to get a product used in an unapproved manner would likely be viewed as off-label promotion of the product – which is prohibited by Abbott policies and is illegal in many jurisdictions. |
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The question of how we conduct or support research is also of interest to regulatory authorities. |
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In most trials, government agencies and regulatory authorities specify requirements for nearly every aspect of the research process. CLICK THE RESEARCH REQUIREMENTS BUTTON TO LEARN MORE. |
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RESEARCH REQUIREMENTS Authorities specify requirements relating to:
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In addition, voluntary standards, such as Good Clinical Practice (GCP) and Good Scientific Practice (GSP), set out further guidelines designed. These guidelines help to ensure both the integrity of the scientific method, as well as patient safety and consent. There are even guidelines, such as the International Committee of Medical Journal Editors (ICMJE), that set out criteria for who can and should be named as authors on scientific research publications. |
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Let’s now take a look at some of the internal requirements that help ensure we comply with these laws, regulations, and standards. |
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First and foremost, Abbott ensures that all research fills a legitimate need. That means that before any research begins, Abbott reviews the research proposal to confirm it:
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Once approved, Abbott selects investigators and sites based on relevant criteria, such as:
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Abbott never bases its selection decisions on marketing objectives, such as the desire to gain or improve access to particular customers or to reward customers for the value or volume of their business. Abbott also has requirements to ensure that investigators and sites selected to conduct research are not debarred, restricted, or otherwise disqualified from conducting research by any relevant regulatory authority or governing body. |
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Compensation paid to investigators or sites is always reasonable and based on fair market value for the country where the research is conducted. Compensation and other terms reflective of materials, overhead and any other support provided is documented in a contract with the investigator or site conducting the research. And, under no circumstances is compensation ever to be tied to the outcome of the study. |
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Once the study results are available, Abbott requires timely reporting in an objective, accurate, and complete manner. CLICK EACH OF THE PANELS TO LEARN MORE. |
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Company-sponsored Trials In the case of company-sponsored trials where Abbott has control and full responsibility for the study and is required to register and post results, Abbott ensures that these studies are registered, and meaningful study results are shared through scientific posters, medical journals, and publicly accessible clinical trial registries such as clinicaltrials.gov. |
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Investigator-initiated Studies In the case of investigator-initiated studies, where research is initiated, designed, and conducted by external investigators and institutions, Abbott has less control but still uses reasonable effort to promote disclosure of the study results in a timely and reasonable manner. |
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Abbott also has additional requirements in place to ensure the safe and appropriate conduct of scientific research. These checks and balances help to ensure our scientific research activities comply with the laws, regulations, and standards that have been put in place to protect the interests of the people who use and recommend our products. |
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Abbott is committed to ensuring objectivity in research, protecting research participants, and guaranteeing timely and transparent disclosure of study results. Laws and regulations governing why we support research It is illegal to make research payments or provide other items of value in order to improperly induce or reward investigators and HCPs to use or recommend the company’s products. It is also illegal to conduct scientific research as a “disguised” means of promoting unapproved uses of Abbott products. Laws and Regulations governing how we conduct research In most trials, government agencies and regulatory authorities specify requirements for nearly every aspect of the research process. Abbott’s Internal Requirements Abbott’s internal requirements include the following:
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In scientific research, the roles and responsibilities of medical and research personnel differ from those of their sales, marketing, and other non-scientific colleagues. In this section, we will look at some simple things each of us can do in order to ensure Abbott’s research activities always remain focused on the legitimate advancement of science. |
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| Senior Sales Representative I work in sales, what are some of the key things I need to keep in mind? |
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For sales, marketing and other functions not responsible for conducting or managing research, here are three important things to remember. |
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Leave scientific research activities to the research-related functions. Sales, marketing, and similar non-research functions may provide input on strategic priorities for scientific research, but may not direct, control, or unduly influence decisions relating to research activities. |
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Limit your input into investigator or site selection to what is permitted in your policies or procedures. Never lobby research colleagues on behalf of particular investigators or sites. And never demand that a site or investigator be included in a study. |
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Finally, always refer scientific research questions to an appropriate research representative or resource in your division. This includes:
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Activity: Dialogue 58_C_47 |
| Senior R&D Manager I work in R&D. What are the important things I need to do in order to remain compliant? |
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If you are part of Abbott’s scientific, medical, or research team responsible for initiating, designing, and/or managing company-sponsored clinical trials and research studies, here is what you need to do. |
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Always ensure that the trial or study fills a legitimate scientific need and has a clear goal of advancing clinical or scientific understanding. For example, if you are reviewing a proposed IIS, ensure that
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Only select investigators and sites for research based on objective criteria relevant to the research itself. |
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Make sure that all payments for research reflect fair market value. Ensure that payments are only made for actual research performed, and always based on fair market value for the services being performed. |
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Always ensure the appropriate and timely reporting of meaningful study results in an objective, accurate, and complete manner as required by Abbott policies and procedures. Regardless of outcome, never suppress or prohibit the publication of study results. |
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Be fully transparent regarding involvement in the research and publication process. Always ensure that Abbott’s involvement (including your own personal involvement) is disclosed in accordance with applicable requirements (e.g., the Abbott Publication Policy). |
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Always respect the independent nature of IIS research by following applicable requirements regarding Abbott involvement. That means:
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If you are unsure or have any questions about your role and responsibilities in respect to scientific research, it is usually best to speak to your manager first. Your manager knows you and your work environment, and is closest to the issues. The Office of Ethics and Compliance (OEC) and Legal are also resources that can help you analyze the situation and brainstorm alternatives. |
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If you have concerns about the research practices of a colleague or third-party partner, talk to the OEC or Legal, or voice your concerns via the OEC Helpline at speakup.abbott.com. (The OEC Helpline is available 24 hours a day 7 days a week and allows you to submit concerns online or by calling an operator who speaks your language.) |
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In scientific research, the roles and responsibilities of medical and research personnel differ from those of their sales, marketing, and other non-scientific colleagues. Sales, marketing, and other similar functions For sales, marketing and other functions not responsible for conducting or managing research, here are three important things to remember:
Research and Scientific Functions If you are part of Abbott’s scientific, medical, or research team responsible for initiating, designing, and/or managing company-sponsored clinical trials and research studies, here is what you need to do:
Where to go for support If you are unsure or have any questions about your role and responsibilities in respect to scientific research, it is usually best to speak to your manager first. If you have concerns about the research practices of a colleague or third-party partner, talk to the OEC or Legal, or voice your concerns via the OEC Helpline at speakup.abbott.com. (The OEC Helpline is available 24 hours a day 7 days a week and allows you to submit concerns online or by calling an operator who speaks your language.) |
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Manager If you have questions about scientific research or have concerns about research practices of a colleague or a third-party, the best place to start is with your manager. Written Standards
Office of Ethics and Compliance (OEC)
Legal Division If you have questions about laws and regulations that govern scientific research, the Legal Division can assist you. Vendor Credentialing Many hospitals are now requesting specific documentation that indicates a company representative is qualified to gain access to the Health Care Organization. If you receive such a request, go to hcir.oneabbott.com for information and guidance. |
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Quick Reference Cards Click here to review summaries of each section of this course. Course Transcript Click here for a full transcript of the course. |
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Activity: Introduction 71_C_53 |
The Knowledge Check consists of 10 questions. You must score 80% or higher to successfully complete this course. When you are ready, click the Knowledge Check button to begin. |
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Question 1: Scenario 72_C_54 |
You should talk to the OEC or Legal if you have concerns about the: |
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Question 1: Options 73_C_54 |
[1] Research practices of a colleague. [2] Involvement of sales and marketing personnel in ISS activities. [3] Research activities of third-party partners. [4] All of the above. |
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Question 1: Feedback 74_C_54 |
If you have concerns about the research practices of a colleague or third-party partner, talk to the OEC or Legal, or voice your concerns via the OEC Helpline at speakup.abbott.com. For more information about the correct answer, see Section 4.3, Where to Go for Support. |
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Question 2: Scenario 75_C_54 |
Abbott selects investigators and sites to perform research based on criteria such as: |
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Question 2: Options 76_C_54 |
[1] Qualifications and expertise. [2] Ability to gain or improve access to customers. [3] Both 1 and 2. |
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Question 2: Feedback 77_C_54 |
Abbott’s selection decisions are never based on marketing objectives, such as the desire to gain or improve access to particular customers or to reward customers for the value or volume of their business. Abbott selects investigators and sites based only on criteria relevant to the research itself. For more information about the correct answer, see Section 3.2, Laws, Regulations, and Standards. |
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Question 3: Scenario 78_C_54 |
Abbott ensures that all research proposals are developed, reviewed, and/or approved by relevant scientific or medical personnel in order to confirm that the research: |
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Question 3: Options 79_C_54 |
[1] Follows appropriate clinical or scientific practices. [2] Has a clear hypothesis or end point. [3] Has the legitimate goal of advancing clinical or scientific understanding. [4] All of the above. |
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Question 3: Feedback 80_C_54 |
Abbott’s scientific or medical personnel review and confirm that all research fills a legitimate scientific need or interest and has a clear and legitimate goal of advancing clinical or scientific understanding. For example, research is assessed to confirm it follows appropriate clinical or scientific practice and has a clear hypothesis or end point. For more information about the correct answer, see Section 3.3, Abbott’s Internal Requirements. |
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Question 4: Scenario 81_C_54 |
Studies that have the objective of introducing a new product or therapy to physicians: |
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Question 4: Options 82_C_54 |
[1] Are permitted for new indications of already approved products. [2] Can be conducted only in markets where there is a lot of competition between companies trying to sell similar products. [3] Could be considered illegal if the payment is intended to reward or induce investigators to use or recommend a particular product. |
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Question 4: Feedback 83_C_54 |
Studies, where the intended objective is to introduce a new product or therapy to physicians, spur sales of the product, or reward physicians for using a product – rather than test a scientific hypothesis or collect data to fill a legitimate need – are often called “seeding trials” or “marketing trials.” Such trials could be considered illegal, if the payment is intended to reward or induce investigators to use or recommend a particular product. For more information about the correct answer, see 3.2, Laws, Regulations, and Standards. |
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Question 5: Scenario 84_C_54 |
Sales, marketing, and other similar functions may only respond to a scientific research question if it is unsolicited. |
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Question 5: Options 85_C_54 |
[1] True. [2] False. |
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Question 5: Feedback 86_C_54 |
Sales, marketing, and other similar functions should refer all scientific research questions to an appropriate research representative or resource in their division. For more information about the correct answer, see Section 4.2, What to Do – Non-Scientific Functions. |
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Question 6: Scenario 87_C_54 |
Scientific and medical personnel involved in providing support for an Investigator-Initiated Study may provide assistance in protocol design and manuscript development. |
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Question 6: Options 88_C_54 |
[1] True. [2] False. |
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Question 6: Feedback 89_C_54 |
Scientific, medical, or research teams involved in providing support for Investigator-Initiated Studies/Investigator-Sponsored Studies must always respect the independent nature of the research by following applicable requirements regarding Abbott involvement. That means:
For more information about the correct answer, see Section 4.3, What to Do – Research and Scientific Functions. |
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Question 7: Scenario 90_C_54 |
Sales and marketing personnel may: |
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Question 7: Options 91_C_54 |
[1] Provide input into investigator or site selection as permitted by applicable policies and procedures. [2] Lobby research colleagues on behalf of investigators. [3] Demand that a site or investigator be included in a study. [4] All of the above. |
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Question 7: Feedback 92_C_54 |
Sales and marketing personnel may provide input into investigator or site selection as allowed by applicable policies or procedures. However, they may never lobby research colleagues on behalf of particular investigators or sites, or demand that a site or investigator be included in a study. For more information about the correct answer, see Section 4.2, What to Do – Non-Scientific Functions. |
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Question 8: Scenario 93_C_54 |
Abbott is solely responsible for the conduct of: |
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Question 8: Options 94_C_54 |
[1] Company-sponsored trials. [2] Investigator-Initiated trials. [3] Both 1 and 2. |
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Question 8: Feedback 95_C_54 |
Abbott is only responsible for the conduct of company-sponsored trials. While we may in some cases choose to provide funding and/or other support for Investigator-Initiated Studies, we are not the study sponsor and are not responsible for conduct of the study. For more information about the correct answer, see Section 2.3, The Types of Research We Support. |
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Question 9: Scenario 96_C_54 |
Compensation paid to investigators or sites must be based on fair market value for the country where: |
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Question 9: Options 97_C_54 |
[1] The protocol is designed. [2] The research is conducted. [3] The trial is managed. |
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Question 9: Feedback 98_C_54 |
Compensation paid to investigators or sites must be based on fair market value for the country where the research is conducted. For more information about the correct answer, see Section 3.3, Abbott’s Internal Requirements. |
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Question 10: Scenario 99_C_54 |
Compensation paid to an investigator may be tied to the outcome of an Investigator-Initiated Study. |
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Question 10: Options 100_C_54 |
[1] True. [2] False. |
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Question 10: Feedback 101_C_54 |
Under no circumstances can compensation ever be tied to the outcomes of a study. For more information about the correct answer, see Section 3.3, Abbott’s Internal Requirements. |
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All questions remain unanswered |
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Activity: Overall Feedback 103_C_55 |
No results are available, as you have not completed the Knowledge Check. Congratulations! You have successfully passed the Knowledge Check and completed the course. Please review your results below by clicking on each question. Once you are done, you must click the EXIT [X] icon in the course title bar before closing your browser window or browser tab. Sorry, you did not pass the Knowledge Check. Take a few minutes to review your results below by clicking on each question. When you are done, click the Retake Knowledge Check button. |
104_toc_1 |
Introduction |
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Welcome |
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Objectives |
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Tutorial |
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Advancing Science |
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Overview |
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Why We Conduct Research |
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The Types of Research We Support |
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Advancing Science: Quick Reference |
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Scientific Integrity |
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Overview |
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Laws, Regulations, and Standards |
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Abbott’s Internal Requirements |
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Scientific Integrity: Quick Reference |
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Playing Your Part |
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Overview |
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What to Do – Non-Scientific Functions |
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What to Do – Research and Scientific Functions |
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Where to Go for Support |
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Playing Your Part: Quick Reference |
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Resources |
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Where to Get Help |
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Reference Material |
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Knowledge Check |
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Introduction |
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Knowledge Check |
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Scientific Research Overview |
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Course Description: Scientific research helps us produce products that are not only safe and effective, but also easier to use, more cost effective, and more reliable. The aim of this course is to explain Abbott’s commitment to safeguarding the integrity of scientific research, and to provide practical advice on how to conduct and support research not only in the right way, but also for the right reasons. |
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Where to Get Help |
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