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iiBIG - Clinical Study Teamwork "Building Effective Partnerships"
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What activities did you attend at the event?
Agreement
By completing this form, you attest that you have participated in all selected activities in thier entirety.
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the speaker(s) as a group.  You will have the opportunity to elaborate on an individual speaker in the following question. 
Please rate the following:
The program was relevant to my work.
Content matched stated objectives.
Usefulness of handouts/AV.
Quality of facilities.
How well did the educational sessions give a balanced view of therapeutic options, including the use of generic names?
If you rated any of the above questions with 'fair,' 'poor,' 'disagree,' or 'strongly disagree' please explain in detail (e.g. session title, speaker name, situtation):
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
If you have additional comments regarding the session or individual speaker(s) - e.g. teaching ability, expertise, organization of materials, etc. - please use the space below:
Having completed the activity, please rate your ability to meet each of the following objectives:
Describe the changing drug development landscape.
Describe new opportunities to improve drug development performance and efficiency
Discuss opportunities and approaches to address these concerns
Describe specific strategies and tactics of organizations looking to improve their quality and performance
Describe key things to highlight when marketing your center’s “exceptionality”.
Define the fundamentals of social media recruitment.
Demonstrate how to use case studies to market exceptional successes.
Examine ways to establish a collaborative environment
Recommend tips on how to maintain transparency
Propose ways to share compliance responsibilities
Discuss issues and present methods to successfully consent vulnerable subjects   
Discuss important strategies for working with special populations 
 Discuss the role and responsibilities of the PI and IRB when consenting children and special populations
Examine how to share risks
Identify what risks should be assessed
Identify ways to establish absolute clarity in roles and responsibilities from the outset
Describe the approach taken by a dedicated research site to monitor its performance
Discuss the value added to the research process by self monitoring performance at the site level
Review how to set goals for workload of research nurses and ancillary staff
Describe  key ways to  improve the site selection process
Identify holdups in CTA and Budget negotiations
Recommend  smarter recruitment strategies
Discover why source documentation is the second most commonly cited deficiency in FDA inspections
Identify the words attributable and contemporeous in Source Documentation
Explain why the reality of source documentation as "working documents" is impractical
Identify the budget needs of sponsor and sites
Discuss how to negotiate fair Clinical Trial contracts
Identify Best Practices for cooperation at clinical sites
Identify effective techniques used in the recruitment process
Recommend how to deal successfully with the key challenges with Sonsor/CRO/Sites as they relate to efficient recruitment
Recommend when Risk Based Monitoring (RBM) should be implemented
Discuss how to implement RBM across your program
Examine what should be considered in Risk Based Monitoring
Identify key ways patients and clinicians are working together to shape therapeutic research
Discuss how to determine What patients know and identify patients unique expertise to share with research clinicians
Explore ways to involve all care-givers in the research process with patients
Identify solutions for fast track regulatory submissions
Identify the benefits of International Clinical Research
Identify opportunities to educate Sponsors and CROs on the advantages of International Clinical Research
Identify Trends during FDA inspections
Identify how this tracks with Audit Outcomes

Define a "small virtual" Pharmaceutical or biotechnology company

Discuss specific hurdles faced by small, virtual companies and their impact on outsourcing and partnerships

Analyze Inadequate executions of the trial

Assess Training and implementation

Summarize key trends and their expect impact
Evaluate the various approaches to maximize  recruitment of patients
Summarize FDA approach to clinical site inspections in the past 2 years.

Discuss strategies to maximize effectiveness of partnering relationships from the company and partner perspectives

Discuss reasons for inadequate funding

Objective 1: Promote professional development with strategies for managing the Clinical Research Process
By meeting the above objective my professional competence will increase because I have acquired new strategies to use in my practice.
By meeting the above objective my professional performance will improve because I should be able to implement the new strategies.
By meeting the above objective my patient outcomes should improve due to the implementation of newly-learned strategies.
Objective 2: Identify and apply effective strategies for managing Clinical Research Operations
By meeting the above objective my professional competence will increase because I have acquired new strategies to use in my practice.
By meeting the above objective my professional performance will improve because I should be able to implement the new strategies.
By meeting the above objective my patient outcomes should improve due to the implementation of newly-learned strategies.
Objective 3: Define and implement effective communications between Sponsors and CROs to build successful partnerships
By meeting the above objective my professional competence will increase because I have acquired new strategies to use in my practice.
By meeting the above objective my professional performance will improve because I should be able to implement the new strategies.
By meeting the above objective my patient outcomes should improve due to the implementation of newly-learned strategies.
Please answer the following:
Do you believe this activity was appropriate for the scope of your professional activities?
Was the educational content scientifically sound?
If faculty spoke about off-label or investigational uses of a product, was that information disclosed to you?
Was the mode of education effective to learning?
If you answered "No" to any of the above questions, please explain.
Did you perceive any product/service/company/commercial bias in any educational session you attended or materials you received?
If you answered "Yes" to the above question, please detail the situation below (e.g. session title, speaker name):
Were you solicited by sales personnel in an educational room (other areas do not matter) while you attended this educational activity?
If you answered "Yes" to the above question, please explain in detail (e.g. who, when, where):
How much did you learn as a result of this education program?
What specifically did you learn during this activity that you intend to integrate into your practice?

What questions have arisen in your practice for which you need answers/strategies that you can implement?

What patient/client problems or patient/client challenges do you feel you are not able to address appropriately or to your satisfaction?
What problems are your patients/clients communicating to you that need attention or follow up?

Are you interested in basic, intermediate or advanced level trainings?

What barriers might you have that would interfere with implementation of new information learned from this training?

How can this training (the overall meeting) be improved to better impact competence, performance and/or patient/client outcomes?

Additional comments:

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