Advanced Clinical Monitoring and Site Management Training Course

Advanced Clinical Monitoring and Site Management Training Course

Introduction

The landscape of clinical trials is rapidly evolving, driven by globalization, decentralized clinical trials (DCTs), and stringent regulatory expectations like ICH GCP E6(R3). Advanced Clinical Monitoring and Site Management Training Course is designed to equip clinical research professionals with the next-level competencies essential for strategic site oversight and proactive risk management. Traditional monitoring methods are no longer sufficient to ensure data integrity and patient safety in complex, multi-site trials. Our course focuses on mastering Risk-Based Monitoring (RBM) principles, leveraging e-Clinical technologies, and applying sophisticated quality management systems to enhance efficiency and compliance across the entire clinical trial lifecycle, moving beyond reactive site visits to becoming strategic partners in clinical development.

This intensive program offers a deep dive into the practical application of advanced monitoring techniques, emphasizing the development of Corrective and Preventive Action (CAPA) plans, effective fraud detection, and successful regulatory inspection readiness. Participants will gain expertise in optimizing site performance through data-driven insights and centralized monitoring strategies. The core focus is on transforming the monitor's role from a checker to a strategic clinical trial leader who can confidently navigate complex ethical and regulatory challenges, mitigate risks effectively, and drive the timely and ethical conduct of global clinical research.

Course Duration

10 days

Course Objectives

1. Master the application of ICH GCP E6(R3) principles in complex global clinical trials.
2. Develop and implement advanced Risk-Based Monitoring (RBM) strategies for optimal resource allocation.
3. Utilize e-Clinical systems for efficient remote monitoring and data review.
4. Formulate robust Corrective and Preventive Action (CAPA) plans for critical and major protocol deviations.
5. Lead regulatory inspection readiness and successfully navigate FDA/EMA audits at the site level.
6. Analyze Key Risk Indicators (KRIs) and site performance metrics using centralized monitoring techniques.
7. Implement effective Decentralized Clinical Trial (DCT) monitoring and oversight models.
8. Ensure meticulous Source Data Review (SDR) and targeted Source Data Verification (SDV) in a risk-based context.
9. Evaluate and manage challenging serious adverse events (SAE) and drug safety reporting scenarios.
10. Apply advanced techniques for fraud detection and managing research misconduct investigations.
11. Enhance communication and stakeholder management skills with investigators and sponsors.
12. Oversee the financial and logistical aspects of site management, including site payments and IP accountability.
13. Drive continuous Quality by Design (QbD) improvements in site operations and monitoring processes.

Target Audience

1. Clinical Research Associates (CRAs) and Senior CRAs.
2. Clinical Team Leads and Clinical Operations Managers.
3. Clinical Trial Coordinators (CRCs).
4. Quality Assurance (QA) Auditors.
5. Drug Safety/Pharmacovigilance.
6. Clinical Data Managers.
7. Medical Monitors and Investigational Site Staff.
8. Professionals from CROs or Sponsor Organizations.

Course Modules

Module 1: The Evolving Role of the Advanced Monitor

• Current ICH GCP E6(R3) and regulatory expectations
• Transition from traditional to proactive, risk-based monitoring.
• The monitor as a strategic site partner and leader.
• Case Study: Analyzing a major inspection finding related to poor monitoring oversight under ICH E6(R2).
• Defining and utilizing Key Performance Indicators (KPIs) for monitor effectiveness.

Module 2: Mastery of Risk-Based Monitoring (RBM)

• Formalizing risk assessments and risk categorization.
• Developing comprehensive Risk Management Plans (RMPs) and Centralized Monitoring Plans (CMPs).
• Implementing a hybrid monitoring strategy
• Case Study: Redesigning a traditional monitoring plan into an RBM strategy for a multi-center oncology trial.
• Utilizing Key Risk Indicators (KRIs) for early signal detection.

Module 3: Advanced Regulatory Compliance and Inspection Readiness

• In-depth review of the Bioresearch Monitoring (BIMO) program and common FDA 483 observations.
• Preparing the site for regulatory authority inspections
• Investigator Initiated Trials (IITs) oversight and compliance challenges.
• Case Study: Developing a site's CAPA response plan following a critical inspection finding.
• Maintaining an Inspection-Ready Trial Master File (TMF) and site documentation.

Module 4: Effective Corrective and Preventive Action (CAPA)

• The lifecycle of non-compliance and its impact on data integrity.
• Root cause analysis techniques for chronic site issues.
• Developing measurable and time-bound CAPA plans.
• Case Study: Creating a comprehensive CAPA for repeated protocol deviation incidents across multiple sites.
• Tracking CAPA effectiveness and documentation for regulatory review.

Module 5: Strategic Site Selection and Qualification

• Advanced techniques for feasibility assessment and site selection.
• Identifying high-performing sites vs. sites with potential challenges.
• Conducting effective Site Qualification Visits (SQV) with a risk focus.
• Case Study: Using predictive analytics to qualify sites for a DCT with high patient engagement.
• Negotiating and managing Site Confidential Disclosure Agreements (CDAs) and contracts.

Module 6: Protocol Deviations and Data Integrity

• Distinguishing between minor, major, and critical protocol deviations (PDs).
• Systematic review and reporting of unapproved deviations and waivers.
• Implementing measures to minimize data fabrication and research misconduct.
• Case Study: Detecting and managing a situation involving suspected falsification of source data.
• Advanced techniques for Source Data Verification (SDV) and Source Data Review (SDR) in RBM.

Module 7: Pharmacovigilance and Safety Oversight

• Advanced reporting requirements for Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions.
• Reconciliation of safety data between EDC and drug safety databases.
• Managing Adverse Event (AE) reporting compliance at the site level.
• Case Study: Analyzing a complex SAE scenario and verifying timely reporting to the IRB/Ethics Committee.
• Oversight of Investigational Product (IP) safety and accountability reconciliation.

Module 8: Decentralized Clinical Trials (DCT) Monitoring

• Understanding the regulatory and operational challenges of DCTs.
• Monitoring of eConsent, remote data collection, and patient-reported outcomes
• Managing data flow and security in a virtual monitoring environment.
• Case Study: Developing a site monitoring plan for a fully decentralized trial using wearables and telehealth.
• Ensuring patient privacy and data security in DCTs.

Module 9: Centralized Monitoring and Data Analytics

• Tools and methodologies for effective centralized data review and visualization.
• Defining and tracking Key Performance/Quality Indicators.
• Identifying data trends, outliers, and potential systemic site issues remotely.
• Case Study: Utilizing a CTMS dashboard to identify a site requiring an immediate triggered on-site visit.
• Collaborating with Biostatistics and Data Management teams for quality assurance.

Module 10: E-Clinical Systems and Technology

• Mastering the use of Clinical Trial Management Systems (CTMS) for oversight.
• Advanced functions of Electronic Data Capture (EDC) systems and query management.
• Managing the Electronic Trial Master File (eTMF) and ensuring inspection readiness.
• Case Study: Troubleshooting a common data entry or query issue in a major EDC platform
• Introduction to AI and Machine Learning applications in clinical monitoring.

Module 11: Investigational Product (IP) and Device Accountability

• Rigorous reconciliation of Investigational Product at the site and pharmacy level.
• Monitoring the proper storage, dispensing, and disposal of drugs/devices.
• Advanced accountability procedures for high-risk investigational products.
• Case Study: Performing an end-of-study IP reconciliation that led to the discovery of a critical inventory discrepancy.
• Oversight of medical device trials vs. pharmaceutical trials.

Module 12: Site Budget and Contract Oversight

• Understanding the components of a clinical trial budget and site payment schedules.
• Monitoring site payment compliance and addressing financial queries.
• Managing contract amendments and addressing scope creep.
• Case Study: Resolving a prolonged site payment dispute that threatened site withdrawal from the study.
• Oversight of site-related vendor contracts

Module 13: Site Communication and Negotiation Skills

• Developing strategies for difficult conversations with investigators and site staff.
• Effective conflict resolution and managing non-compliant sites.
• Techniques for providing constructive, performance-driven feedback.
• Case Study: Role-playing a scenario with a Principal Investigator reluctant to sign off on a corrective action plan.
• Cross-cultural communication in global clinical trials.

Module 14: Final Monitoring and Close-Out Activities

• Detailed procedures for the Close-Out Visit (COV) and final documentation review.
• Ensuring final resolution of all queries, deviations, and CAPAs.
• Oversight of archive procedures for essential documents and data retention requirements.
• Case Study: Completing a complex close-out, ensuring all data locks and site archives are compliant.
• Monitoring long-term follow-up requirements post-study closure.

Module 15: Career Development for the Advanced CRA

• Developing a career path from CRA to Clinical Project Manager or functional lead.
• Mentoring and coaching junior clinical research staff.
• Strategies for thought leadership and presenting best practices to sponsors.
• Case Study: Creating a personalized professional development plan to specialize in RBM or DCTs.
• Future trends: Artificial Intelligence in monitoring and regulatory changes.

Training Methodology

This course employs a participatory and hands-on approach to ensure practical learning, including:

• Interactive lectures and presentations.
• Group discussions and brainstorming sessions.
• Hands-on exercises using real-world datasets.
• Role-playing and scenario-based simulations.
• Analysis of case studies to bridge theory and practice.
• Peer-to-peer learning and networking.
• Expert-led Q&A sessions.
• Continuous feedback and personalized guidance.

Register as a group from 3 participants for a Discount

Send us an email: info@datastatresearch.org or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.