PharmaSchool: Document Management

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: CTC008

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Duration: 1 day

Description:

This course is suitable for those working with clinical trial documentation, whether in generating the documents, filing and document management or archiving.

Objectives:

Document management is critical to success of clinical trials and also key for transparency.  This can be a complex process with documents created in a combination of paper and electronic formats. This course will provide delegates with the following:

Outline of the key documents required
Overview of Document management techniques
Practical advice for both electronic and paper archiving

Training Methods:

Delivery of the course will consist of a combination of presentations by the trainer, group discussion and case studies. This course will also be supported by additional resources available through the PharmaSchool Learning Management Centre.

Example content:

Introduction

Why Do We Have To Have Essential Documents?
Where Do I Start?

Essential Documents

Before The Trial
During the Trial
After the Trial
Filing: TMF and ISF
Correspondence
File Notes

Document Management

Tracking
Version control paper, electronic and scanned documents
Audit trail
Rationalisation of multiple copies
Dealing with the gaps

Finalising the documentation

Archiving requirements
Record Retention

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