2.2.3 Documentation of the experiment and deviations

A. Background & Definitions

Experimental record: for definition please check the item 3.1.2.1

Integrity of the experimental records: for details please check the item 3.1.2

Witness: for definition please see 3.1.2.2

The following documents should be created before the study execution and in place during the course of the study:

study plan (and amendments, if any)
required allowance to perform the study (e.g. animal use allowance)
instructions for handling research material or other materials with unknown or established risk to human health and environment (if applicable)
certificates of analysis of investigational products (if applicable)
description of processes to identify, report and record changes in routinely performed assays (if applicable)

The following documents should be in place to describe what was done during the course of the study:

all activities related to the study execution must be recorded, dated, initialed (or signed) and saved
all activities should be recorded at the time they are generated or observed (i.e. recorded without a significant delay)
any changes related to the study execution must be documented - why, when and by whom (when documents are amended, one should make sure not to over-write the original version)

PLEASE DO NOT FORGET

To implement measures securing data integrity (see section 3.1.2 for details)
To consider implementing a witnessing if generated results are intended to support intellectual property claims

tba

back to Toolbox