Archiving

This section contains the following:

Introduction
Things to consider
Additional resources

Introduction

Archiving should be undertaken at both the co-ordinating centre and any sites involved in the trial. At the start of the trial there should be an agreement from each centre on how they will undertake archiving and confirmation should be given in writing.

After a trial has been completed essential documents must be retained for a sufficient period of time to allow for audit and inspection by regulatory authorities. Essential documents are those which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced (CPMP/ICH/135/95). These documents should show that the investigator and sponsor have complied with the standards of Good Clinical Practice (GCP). It is important that a master file containing details of all the necessary essential documentation is set up at the start of the trial and is maintained throughout the trial.

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Things to consider

Storage

No unnecessary correspondence should be included
Records should be legible
The integrity and confidentiality of the data must be protected and continues to be the ultimate responsibility of the sponsor while in storage.
Access to archives should be restricted to authorised personnel
A log of the archived material should be kept so that documents can be tracked and retrieved when necessary.

Duration of Archiving

The sponsor or someone on behalf of the sponsor will help decide the duration of archiving
The requirements of the funding body should also be considered and these may vary from 5 to 20 years duration
The review/destroy year should follow research governance guidance and should not be excessive.
The reason for destruction of essential documents should be documented and signed by a person with the appropriate authority and this record kept for a further five years from the date of destruction.

Additional resources

Example archive approval forms

The University of Aberdeen, College of Life Sciences and Medicine, procedure for archiving and template archive approval form.