Investigator Site File (ISF) Training

This course is aimed at staff delegated by Principal Investigators to manage, maintain, or QC the Investigator Site File (ISF)

Investigator Site File (ISF) Training

This course is aimed at staff delegated by Principal Investigators to manage, maintain, or QC the Investigator Site File (ISF). It also supports CRAs involved in ISF QC to implement best practices for audit readiness.

Participants will:

  • Understand the ISF’s importance and regulatory requirements.
  • Learn to organize filing systems and maintain key documents.
  • Gain practical skills in ISF management to ensure audit readiness.
  • Receive certification upon successful completion of the course and assessment.
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Course Format

  • Understand the ISF’s importance and regulatory requirements.
  • Learn to organize filing systems and maintain key documents.
  • Gain practical skills in ISF management to ensure audit readiness.
  • Receive certification upon successful completion of the course and assessment.
Contact Us

Course Format

Day 1:

  • Introduction to ISF and its importance

  • Regulatory requirements for ISF/TMF maintenance

  • Key documents for ISF filing

  • Organisation of filing systems

  • Best practices for ISF management

  • Readiness for audits and inspections

Day 2:

  • Practical exercises

  • Recap and competency assessment

The course is co-presented with a facilitator highly experienced in ISF management.

Attendees will receive a certificate for successfully attending and passing the ISF Management course.

Certication

Attendees will receive a certificate for successfully attending and passing the ISF Management course.

Cost

R5400.00 for 2 days classroom style training
(offered on special request only – contact Dr Aspinall via email)

VAT is not applicable.

Booking/Registration

Complete our registration form online, or use the contact details below, and we’ll provide you with more information.

Register Online

HPCSA-Accredited Training Provider

With a professional learning environment and all the resources you need, we are confident this course will be a valuable fit for your professional development—whether you are here to build foundational knowledge or to renew your GCP certification.

“For any questions or support, please reach out—we’re here to assist and look forward to your participation.”

Frequently Asked Questions

1. Who should attend this course?

Staff responsible for managing or QCing the Investigator Site File at a clinical research site.

2. What does the course cover?

ISF structure, filing systems, regulatory requirements, audits, inspections, and best practices.

3. How is the course delivered?

2-day classroom-style training with practical exercises and assessment.

4. Is certification provided?


Yes, upon successful completion of the course and assessment.

5. What is the cost?


R5,400 per person (VAT not applicable).

Register For This Course

Quick Course Summary

  • Who should attend:
    Designed for staff delegated to manage or QC the Investigator Site File at clinical research sites.
  • Content covered:
    Covers regulatory requirements, key documents, filing systems, and best practices.
  • Format:
    Classroom-style over 2 days with practical exercises and competency assessment.
  • Certification:
    Certificate awarded upon successful completion. Cost: R5,400 (VAT not applicable).
  • Presenter:
    Co-presented with an experienced ISF facilitator.

Ready to get started?

Should you require any information, if you want to book your place on a course, or would like to discuss training options, please contact us.

Contact Details

Phone: +27 83 225 9656
Email: info@rrtraining.co.za

Course Registration

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