2.2.3 Documentation of the experiment and deviations: Difference between revisions
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== B. Guidance & Expectations == | == B. Guidance & Expectations == | ||
The following documents should be created before the study execution and in place during the course of the study: | The following documents should be created before the study execution and in place during the course of the study: | ||
* | * [[2.1.1 Study protocol]] (and amendments, if any) | ||
* required allowance to perform the study (e.g. animal use allowance) | * 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) | * instructions for handling research material or other materials with unknown or established risk to human health and environment (if applicable) | ||
| Line 21: | Line 21: | ||
* 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) | * 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 | '''PLEASE DO NOT FORGET''' | ||
* To implement measures securing data integrity (see section | * To implement measures securing data integrity (see section [[3.1.2 Procedures for how and when to record data| 3.1.2]] for details) | ||
* To consider implementing a witnessing if generated results are intended to support intellectual property claims | * To consider implementing a witnessing if generated results are intended to support intellectual property claims | ||
| | ||
== C. Resources == | == C. Resources == | ||
The following two videos provide a short description on data integrity and the guiding principles of ALCOA: | |||
{{#ev:youtube|https://www.youtube.com/watch?v=AdY9usIFLT8}} | |||
{{#ev:youtube|https://www.youtube.com/watch?v=Xh-lt4pALq0}} | |||
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Latest revision as of 12:44, 28 September 2026
A. Background & Definitions
Experimental record: for definition please check the item 3.1.2.1 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 3.1.2.2 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:
- 2.1.1 Study protocol (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
C. Resources
The following two videos provide a short description on data integrity and the guiding principles of ALCOA:
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Next item: 2.3.1 Generation, recording, handling and archiving of raw data