2.2.3 Documentation of the experiment and deviations

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​​​​​​A. Background & Definitions

Experimental record: for definition please check the item Traceability of data and any person having impact on data​

Integrity of the experimental records: for details please check the item 3.1.2 Procedures for how and when to record data

Witness: for definition please see ​ Process for witnessing of records

B. Guidance & Expectations

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 materia​l or other materials with unknown or established risk to human health and environment (if applicable)
  • certificates of analysis​ of investi​​gational 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)


  • 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

​C. Resources

to be added

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Next item: 2.3.1 Generation, recording, handling and archiving of raw data