SITE INITIATION, MONITORING, AND CLOSEOUT – BASICS - Qtech-Sol USA offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Clinical Research
 
Duration:
4 Weeks / 110 Hours
 
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SIVM: Site Initiation, Monitoring, and Closeout – Basics

Introduction – Site Initiation, Monitoring & Closeout

Site management is one of the most critical functions in clinical trial execution. From initiating a site, ensuring ongoing monitoring, and performing a final closeout, every step requires adherence to ICH-GCP standards, regulatory guidelines, and trial protocols. These activities ensure that patient safety, data quality, and regulatory compliance are maintained throughout the trial lifecycle.

The SIVM program introduces learners to the foundational concepts of site initiation, monitoring visits, and site closeout activities. It prepares learners for CRA, CTA, and CRC roles by providing insight into site-level responsibilities and sponsor/CRO oversight processes.

Course Name :  Site Initiation, Monitoring, and Closeout – Basics
Course Code :  SIVM
Experience Level :  Entry-Level
Qualification :  Bachelor’s / Master’s in Life Sciences, Nursing, Pharmacy, Public Health, or related fields
Student Category :  Clinical Research Associates (CRA), Clinical Research Coordinators (CRC), Clinical Trial Assistants (CTA), Career Changers

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 4 weeks (110 hours)
  2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
Key Learning Objectives

   By completing this program, learners will:

  1. Understand the purpose and workflow of site initiation, monitoring, and closeout.
  2. Learn the roles of CRAs, CRCs, and CTAs in site management.
  3. Explore regulatory requirements (ICH-GCP, FDA, EMA) for site activities.
  4. Gain knowledge of essential documents required for initiation and closeout.
  5. Learn how to conduct monitoring visits (remote, on-site, and hybrid).
  6. Review common site issues (protocol deviations, data queries, compliance gaps).
  7. Practise site visit scenarios to ensure inspection readiness.
Who Should Take This Course
  1. Clinical Research Associates (CRAs) beginning their careers.
  2. Clinical Research Coordinators (CRCs) supporting site management.
  3. Clinical Trial Assistants (CTAs) learning sponsor/CRO oversight roles.
  4. Healthcare professionals transitioning into clinical trial operations.
  5. Career changers preparing for entry-level clinical operations positions.
Benefits & Outcomes
  1. Build confidence in conducting site initiation, monitoring, and closeout activities.
  2. Learn to ensure regulatory compliance and data integrity at sites.
  3. Be prepared for CRA/CRC/CTA job responsibilities.
  4. Strengthen readiness for inspections and audits at site level.
  5. Develop a pathway toward advanced CRA and CSM roles.

    6. .

Career Pathways: After completing this course
  1. Clinical Research Associate (CRA – In-House or Field)
  2. Clinical Research Coordinator (CRC)
  3. Clinical Trial Assistant (CTA)
  4. Clinical Site Manager
  5. Clinical Study Manager (progression pathway)

Curriculum & Modules

Modules
1. Introduction to Site Management in Clinical Trials

2. Site Initiation Visits (SIV) – Preparation & Execution

3. Monitoring Visits – Purpose, Frequency & Documentation

4. Monitoring Techniques – On-Site, Remote, and Risk-Based Monitoring

5. Essential Documents for SIV, Monitoring, and Closeout (ICH-GCP, TMF)

6. Handling Protocol Deviations & Query Resolution During Visits

7. Site Closeout – Deliverables, Documentation, and Inspections

8. CRA/CRC/CTA Role Responsibilities Across Visits

9. Case Studies – Managing a Trial Site from Start to Finish
Getting in Touch:

For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.