Chapter 3 — Implementation

Chapter 3 — Implementation

3.1 Policy Statement

ARmed for Medical Training and Consultancy – LLC – OP.C shall ensure that all CME/CPD activities are implemented according to approved plans, in full compliance with DOH standards for integrity, independence, and learner protection.
Implementation includes the delivery of educational content, management of attendance, assessments, faculty performance monitoring, and issuance of certificates, supported by proper documentation and quality assurance procedures.

Reference: DOH requires that CME/CPD providers implement activities in alignment with approved objectives, maintain independence from commercial influence, and ensure reliable credit calculation.

3.2 Rationale

  • Quality Assurance Manual: mandates that implementation must ensure accurate credit awarding, attendance verification, and independence from bias.
  • Activity Development Guide: stresses the importance of delivery methods that engage learners, align with learning objectives, and includes assessments to measure changes in competence, performance, or outcomes.
  • Proper implementation safeguards learners, assures regulators of compliance, and builds trust with stakeholders.

3.3 Faculty Management

3.3.1 Eligibility

  • Faculty must demonstrate recognized expertise in the relevant discipline.
  • Minimum of three years teaching or professional practice experience preferred.
  • All faculty must disclose potential conflicts of interest within the past 24 months.

3.3.2 Responsibilities

  • Delivering educational content consistently with approved objectives.
  • Ensure content is evidence-based, unbiased, and up to date.
  • Incorporate interactive teaching methods (simulation, case discussions, polling).
  • Submit teaching materials in advance for review by the Scientific Committee.

3.3.3 Performance Review

  • Faculty performance is evaluated through learner feedback, peer review, and activity evaluation reports.
  • Poor performance or repeated learner dissatisfaction triggers remediation or replacement.

3.4 Learner Engagement

3.4.1 Delivery Modes

  • Live/In-person: workshops, seminars, conferences.
  • Hybrid: combination of in-person and virtual participation.
  • E-Learning: synchronous (webinars) and asynchronous (LMS modules).

DOH Requirement: E-learning must capture time-on-task, completion records, and assessments for credit eligibility.

3.4.2 Teaching Strategies

  • Case-based discussions and role plays.
  • Simulation-based scenarios for technical and non-technical skills.
  • Gamification, quizzes, and audience response systems.
  • Group projects, reflective writing, and problem-solving tasks.

3.4.3 Learner Support

  • Pre-course materials and reading lists.
  • Technical assistance for virtual platforms.
  • Opportunities for Q&A, peer interaction, and faculty feedback.

3.5 Attendance Management

3.5.1 Verification Systems

  • Primary system: QR code or digital attendance platform.
  • Backup: manual sign-in sheets with dual verification (two staff signatures).
  • For e-learning: unique login IDs, progress tracking, and final completion report.

3.5.2 Minimum Attendance

  • Learners must attend ≥75% of the scheduled activity to qualify for credits.
  • Credits are prorated based on verified minutes attended.

3.5.3 Documentation

  • Attendance logs, QR scans, or LMS reports archived for 6 years.

3.6 Assessments

3.6.1 Types of Assessments

  • Knowledge: pre- and post-tests, MCQs, case questions.
  • Skills: OSATS (Objective Structured Assessment of Technical Skills).
  • Competence: role-play scenarios, decision-making exercises.
  • Performance: follow-up surveys at 2–3 months post-activity.

 

3.6.2 Purpose

  • Confirm achievement of learning objectives.
  • Provide data for evaluation and continuous quality improvement.
  • Serve as eligibility criteria for awarding credits.

3.7 Certificates

  • Certificates issued only after:
  1. Verified attendance.
  2. Completed evaluation.
  3. The required assessments passed (if applicable).
  • Certificates must include:
  1. Provider’s full legal name.
  2. DOH accreditation statement.
  3. Activity title, date, and type.
  4. Number of credits awarded.
  5. Participant’s name and license/ID.

Reference: DOH mandates inclusion of official accreditation statements and prohibits promotional content on certificates.

3.8 Activity File (Implementation Records)

Each CME/CPD activity must maintain a complete Activity File, including:

  1. Approved agenda and learning objectives.
  2. Faculty CVs and COI disclosures.
  3. Teaching materials (slides, handouts).
  4. Attendance records (QR reports, sign-in sheets, LMS logs).
  5. Assessment tools and results.
  6. Certificates issued (samples).
  7. Evaluation reports (learner satisfaction, knowledge gain, outcomes).

Files must be retained for 6 years and made available during DOH audits.

3.9 Independence and Integrity in Implementation

  • No logos, product names, or promotional content in slides, handouts, or assessments.
  • Exhibits or sponsor acknowledgements must be separated from educational spaces.
  • Faculty with unresolved conflicts of interest are prohibited from teaching.
  • Learners must be queried post-activity on perceived bias (included in evaluation forms).

3.10 Escalation & Corrective Actions During Implementation

  • Minor Issues: (e.g., late materials, minor errors in attendance logs) → corrected by Coordinator, documented in CAPA log.
  • Moderate Issues: (e.g., incomplete COI disclosure, delayed evaluation reports) → escalated to Scientific Director.
  • Serious Issues: (e.g., commercial bias, false credit reporting, ethical violations) → escalated to Oversight Committee and reported to DOH within 10 working days.

3.11 Continuous Improvement in Implementation

  • Faculty evaluations and learner feedback analyzed quarterly.
  • Trends (e.g., repeated requests for simulation training) incorporated into planning.
  • Outcomes from assessments feed back into curriculum redesign.
  • QA conducts spot checks on implementation for compliance with DOH.

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