Document Management and Archiving

One day course

Key Objectives:

• Understand  the regulatory framework of GCP documentation including the requirements of  European Clinical and GCP Directives
• Review the GCP requirements for essential documents
• Develop a systematic approach for preparing documents for archiving
• Explore document management solutions that combine physical storage, and digital storage of your active documents
• Identify the requirements for successfully meeting the requirements of audit or regulatory authority inspection

PROGRAMME
 

Documentation and archiving requirements

• What documents should be maintained and archived to comply with EU Framework of GCP documentation including ICH GCP and the CT Directive requirements?
• Non-commercial organisation TMF requirements
• Why/What/when and how long?
• Sponsor
• Investigator site
• Ethics Committees
• The GCP Directive 
• TMF and archiving - What should be filed, for how long and who should have access?

Selection of a suitable off-site storage company

Archiving and Retention

• Preparation of Documents for Archiving
• Tracking of Archived Documents
• Requirements for archiving including indexing and cataloguing
• Requirements of Archives for Long-Term Storage
• Conditions required for archiving eg temperature control, humidity, prevention of water damage etc

Archive Specialist Speaker:  (TBD)
Marketing Director, UK Box-it

Electronic Storage: Bridging the gap between physical and digital data

• document management solutions that combine physical storage, intelligent conversion and digital storage of your active documents
• Fast and reliable access to essential documents is critical to business success, yet many companies encounter problems archiving both physical and electronic records.
• Cost is an important factor in this type of initiative, but by enabling cost-effective access to their records at any time, organisations can substantially reduce operational inefficiencies.

Archive Specialist Guest Speaker: TBD
Director of Client Services, Iron Mountain

Electronic Records including e-source

• Electronic signature and records CFR 21
• FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations 2007
• The EMEA view on electronic source data
• EU guidance

Inspections and audit preparation

• How to prepare for inspection and audit
• What the Inspectors expect
• What questions to inspectors ask and what do they want to see? (discussion to share experiences to improve preparation for the future inspections)