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CME Collaboration

Choosing Educational Partners: Keys to Successful CME Collaboration

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Selection Criteria for CME Providers in Assessing Potential Supporters

 Operations
Administration

  • Medical Education Department

    • Where it resides within the corporate organizational structure

      • Independent

      • Medical Affairs

      • Other

  • Organizational structure of unit (Director, Assistant, Manager)Designated individual at a senior level position, or an executive committee accountable for overseeing Med Ed unit’s compliance with guidelines

    o Numbers of medical education personnel in unit and educational background

    o Responsibilities assigned by product/therapeutic category

    o Primary point of contact to enhance efficiencies

Financial

  • Identification of where Med Ed funding originates and where grants are sourced
     

  • Person(s) responsible for budget allocation and grant review and disbursement

Compliance Program

  • Med Ed relationship to other departments/units in company
     

  • Corporate CME guidelines and processes communicated to other internal units
     

  • Role of regulatory or legal in overseeing CME activities and who is responsible for the ultimate approval, ie, “sign-off”
     

  • Compliance officer that oversees CME compliance
     

  • Historical perspective re: regulatory breaches/warnings
     

  • Published procedures to address warnings
     

  • SOPs established for commercial support
     

  • Utilization of a referral list for CME providers versus a preferred vendor list

Professionalism

  • Service to the CME community
     

  • Active participation in relevant organizations (ACME/PACME, PhRMA, others)
     

  • Employees holding leadership positions in service organizations

Educational Framework

Knowledge Base & Core Competencies

  • Preparation of strategic educational plans and participation in long-range plans for respective franchises
     

  • Documented understanding of adult learning principles and application to CME
     

  • Ongoing training programs for med ed personnel
     

  • Med ed personnel clearly make the distinction between education and promotion and demonstrate that understanding
     

  • Company-specific SOPs regarding interaction with providers; evidence of transparent collaboration
     

  • Types and numbers of programs supported
     

  • SOPs in place re: grantor review to accommodate timelines

CME Process

  • CME provider: collaborator vs. vendor relationship

    • Patient care focused

    • Learner focused

    • Grant process

      • Grant process review done electronically, via phone, hard copy, etc.

      • If electronic, a grant process liaison is assigned to address inquiries

    • Procedures and guidelines for med-ed unit input into CME

    • Procedures that govern interface between marketing, med-ed unit and CME provider: published SOPs

    • Procedures result in complete internal and external transparency


Assessment of learning and behavioral change

  • Appreciation that the support of an outcomes strategy creates regulatory transparency
     

  • Demonstrated ability to support programs that generate outcomes data
     

  • Interest in support of educational interventions that

    • Utilization of proven methods to measure knowledge gained, application of knowledge to practice and behavioral change

    • Differentiation of change in physician behavior and patient outcomes (patient component beyond provider and/or physician control)

    • Differentiation of intent to change and resulting barriers to change

  • Support of practical and cost-effective means to assess outcomes

    • Support of an integrated educational strategy that includes measurement of outcomes

 

Selection Criteria for Grantors in Assessing Potential Providers

Operations
Administration

  • Corporate, staffing, and organizational structure (parent organization; marketing/advertising separate from education)
     

  • Number, credentials, and specialty of personnel (ie, editorial capabilities, project management skills, CME expertise, etc.)
     

  • Demonstrated expertise in therapeutic area(s) of interest
     

  • Demonstrated ability to collaborate with multiple stakeholders
     

  • Demonstrated ability to meet or beat established deadlines

Financial

  • Operational capabilities including the level of documentation and support the company deems necessary to evaluate and substantiate expenses associated with an educational activity (therapeutic/clinical issues, etc.)

Compliance Program

  • Appropriate written policies and procedures concerning specific risk areas including:

    • Firewall structure and integrity

    • Policies to ensure that industry directs personnel to CME provider for the provision of the following: fees, travel reimbursement policy, conflicts of interest, etc.

    • Appropriate communication and responsiveness

    • A means of handling incoming communications including appropriate channels of communication for employee and customer complaints

    • A system to monitor and periodically assess the CME provider’s systems for compliance

  • Appropriate procedures to manage corrective action
     

  • Appropriate policies describing disciplinary actions that can arise from breach of the CME provider’s compliance requirements
     

  • Mechanism for resolving conflict of interest issues

Professionalism

  • Service to the CME community
     

  • Active participation in relevant organizations (ACME/MECCA, NAMEC, others)
     

  • Employees holding leadership positions in service organizations; ACCME site surveyors, etc.

Educational Framework

Adult Learning Principles

  • Application of adult learning principles throughout the educational design process based on education and/or training
     

  • Examples of application: small group discussion, audience response systems, learning over time methods, reinforced learning; question and answer

Accreditation

  • Current accreditation status; number and type of accreditations held from various agencies
     

  • The results of recent assessments and a review of past and pending complaints received by the CME provider (provider could submit last letter of ACCME accreditation as evidence)
     

  • If not accredited, can provide a list of which providers are partners
     

  • Demonstrated ability to partner with other providers; track record of collaboration

Educational Design

  • Input into planning should reflect a shared function of inter-divisional stakeholders who address the following questions from their individual perspectives:

    • Procedures result in complete internal and external transparency

    • Identification of unmet medical needs

    • Existence of clinical data to satisfy those needs

    • Identification of learning objectives required for understanding and to improve delivery of care

    • Identification of target audiences: clinical, patient, etc.

    • Methods to communicate the educational learning objectives by type of audience

    • Definition of success

    • Identification of remaining educational gaps post activity

Assessment of learning and behavioral change

  • Appreciation that the inclusion of an outcomes strategy creates regulatory transparency
     

  • Demonstrated ability to generate outcomes data
     

  • Proven methods to measure knowledge gained, application of knowledge to practice and behavioral change

    • Differentiation of change in physician behavior and patient outcomes (patient component beyond provider and/or physician control)

    • Differentiation of intent to change and resulting barriers to change
       

  • Practical and cost-effective means to measure outcomes

    • Integrated educational strategy that includes measurement of outcomes

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