2.2.3 Documentation of the experiment and deviations - Revision history

Bjoerngerlach: /* B. Guidance & Expectations */

2021-04-15T13:27:02Z

‎B. Guidance & Expectations

2A02:908:182:F8E0:F44A:43E3:950D:CFDA at 19:42, 23 March 2021

2021-03-23T19:42:10Z

Bjoerngerlach at 14:11, 28 October 2020

2020-10-28T14:11:45Z

Bjoerngerlach at 17:21, 5 September 2020

2020-09-05T17:21:04Z

Bjoerngerlach at 17:20, 5 September 2020

2020-09-05T17:20:43Z

Bjoerngerlach at 17:20, 5 September 2020

2020-09-05T17:20:26Z

Bjoerngerlach: Created page with "== A. Background & Definitions == Experimental record: for definition please check the item 3.1.2.1 Integrity of the experimental records: for details plea..."

2020-09-02T15:34:47Z

Created page with "== A. Background & Definitions == Experimental record: for definition please check the item 3.1.2.1 Integrity of the experimental records: for details plea..."

New page

== 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

== 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 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 ==

tba

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back to [[Toolbox]]

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

@@ Line 28: / Line 28: @@
 == C. Resources ==
-to be added
+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}}
 ----------------

@@ Line 23: / Line 23: @@
 PLEASE DO NOT FORGET
-* 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 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

@@ Line 10: / Line 10: @@
 == B. Guidance & Expectations ==
 The following documents should be created before the study execution and in place during the course of the study:
-* study protocol (and amendments, if any)
+* [[2.1.1. Study Protocol|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)
@@ Line 27: / Line 27: @@
 == C. Resources ==
 The following two videos provide a short description on data integrity and the guiding principles of ALCOA:

@@ Line 1: / Line 1: @@
 == A. Background & Definitions ==
-Experimental record: for definition please check the item 3.1.2.1
+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
+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
+Witness: for definition please see [[3.1.2.2 Process for witnessing of records]]
@@ Line 23: / Line 23: @@
 PLEASE DO NOT FORGET
-* To implement measures securing data integrity (see section 3.1.2 for details)
+* 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
 == C. Resources ==
 ----------------

2.2.3 Documentation of the experiment and deviations - Revision history

Bjoerngerlach: /* B. Guidance & Expectations */

2A02:908:182:F8E0:F44A:43E3:950D:CFDA at 19:42, 23 March 2021

Bjoerngerlach at 14:11, 28 October 2020

Bjoerngerlach at 17:21, 5 September 2020

Bjoerngerlach at 17:20, 5 September 2020

Bjoerngerlach at 17:20, 5 September 2020

Bjoerngerlach: Created page with "== ​​​​​​A. Background & Definitions == Experimental record: for definition please check the item 3.1.2.1 Integrity of the experimental records: for details plea..."

Bjoerngerlach: Created page with "== A. Background & Definitions == Experimental record: for definition please check the item 3.1.2.1 Integrity of the experimental records: for details plea..."