GOOD DOCUMENTATION PRACTICES
Good Documentation and Data Integrity Practices must be applied, meaning that data must meet the following criteria.
What is ALCOA+
The amount of time that experimental record containing or cross-referencing the experimental design description must be created.
What is preferably before experiment start date and at the latest within 7 days after experiment start date?
THIS is an important step to ensure experimental records are sound, for e.g., adequate experimental design, correct execution, calculations and results/conclusions, transparency on experiment limitations, completeness of documentation to allow reconstruction
What is Scientific Review?
Readable, permanent and changes are traceable and clearly understood.
What is Legible?
The number of days to complete the experimental record.
What is within a maximum of 30 days following experiment end date?
This person is responsible to ensure that the experiment is executed according to plan, with appropriate scientific rigor and that data recording and referencing is accurate and complete, to allow full reconstruction
Who is the author of the experimental record?
Data is the first recording of data, or an identical copy
What is original?
The timing when In cases where not all details of the experimental design are known before the start of the experiment, these should be documented.
When is during the course of the experiment?
Upon finalization, all reports must be signed/approved and dated by these individuals.
Who are report author and report reviewer?
Data is recorded at the time it is generated or observed.
What is contemporaneous?
In case the Experiment author is responsible for a defined part of an overarching experiment, the experiment author should create a separate experimental record including a cross reference to the overarching experimental record as well as to any other experimental records that contain this for the experimental record that is created
What is input?
Reports that can be used for IB/submission are used as input for the NME document and are stored here.
What is RIMdocs?
The author(s) and all individuals who participated or contributed to the experiment must be clearly identified so that the data can be traced to each individual’s contribution.
What is Attributable?
Platforms for data exchange during collaboration (e.g. OneDrive, Teams) should never be used as this.
What is final repository of data?
In case revisions to final signed reports are required an updated version must be prepared with this.
What is clear indication of the change and the reason for change?