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GCP Compliance in Document Management & Archiving    Back

ICR -The Institute of Clinical Research Course Type: Short courses (CPD) Start Date: Any time
Duration: Full time - 3 Hours Fees/total cost: EUR 56.67 (GBP 42.00)



This module defines documentation and essential documentation requirements under the European regulations. It looks at each document and its purpose in the trial process, identifying which documents are unique to the TMF and ISF. The location of the files will be explored along with filing conventions. The concept of eTMF and electronic records management will also be discussed. The why, what, who and when of archiving of paper documents and electronic archiving will be covered.The specific modalities to the Directive 2005/28/EC on the requirements for non-commercial studies will also be detailed. The requirements of the FDA are not discussed but it must be noted that if a study is conducted under an IND you must satisfy the documentation requirements of the FDA.

The programme is clear and simple in design and gives full instructions for use.




Learning Outcomes

Learning objectives

By the end of this course, you will be able to…

  • Define the documentation and essential documentation requirements necessary to meet regulatory standards

  • Describe each document and outline its purpose in the clinical trial process – identifying which documents are unique to the TMF and ISF

  • Critically appraise methodologies of indexing and filing conventions

  • Discuss the concept of eTMF and electronic records management

  • Develop coherent strategies to manage and satisfy the requirements of archiving essential documentation




Short courses (CPD) - Full time

Start date:
Any time
3 Hours
Teaching method:
Distance Learning
Standard applicant fee:
EUR 56.67 (GBP 42.00)


Course contact information

Information Learning ICR
This course meets 7 out of 9 IMI Education & Training shared quality standards ( Show Details)
  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered
Last update: 27/07/2016