Difference between revisions of "3.1.1 Platform to record data"
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== B. Guidance & Expectations == | == B. Guidance & Expectations == | ||
| − | * Detailed records of an experiment must be provided (see item [[Documentation of the experiment and deviations]]), either via an electronic or paper-based notebook. | + | * Detailed records of an experiment must be provided (see item [[2.2.3 Documentation of the experiment and deviations]]), either via an electronic or paper-based notebook. |
* Data security (see item [[3.1.3 Data security]]) and witnessing (see item [[3.1.2.2 Process for witnessing of records]]) requirements need to be implemented and in place. | * Data security (see item [[3.1.3 Data security]]) and witnessing (see item [[3.1.2.2 Process for witnessing of records]]) requirements need to be implemented and in place. | ||
Revision as of 17:32, 5 September 2020
A. Background & Definitions
ELN (Electronic Laboratory Notebook): primary documentation and storage place for information created in the laboratory in an electronic format (also handwritten notes, e.g. during measurement procedures, should be stored in the ELN).
LIMS: A Laboratory Information Management System (LIMS) is a software that allows to effectively manage samples and associated data. By using a LIMS, a research unit can automate workflows, integrate instruments, and manage samples and associated information.
Record: A research diary entry for an experiment recording all data and pertinent details of an experiment such that a peer could repeat the experiment.
Audit trail: An audit trail is a transparent description of the research steps taken from the start of a research project to the development and reporting of findings. These are records of a sequence of events from which a history may be reconstructed and that are kept regarding what was done in an research investigation.
Each user should define the platform used to record data and ensure their traceability and integrity.
B. Guidance & Expectations
- Detailed records of an experiment must be provided (see item 2.2.3 Documentation of the experiment and deviations), either via an electronic or paper-based notebook.
- Data security (see item 3.1.3 Data security) and witnessing (see item 3.1.2.2 Process for witnessing of records) requirements need to be implemented and in place.
- Paper-based documentation:
- A bound paper notebook must be used. The use of loose pieces of paper must be avoided.
- Entries should be made in permanent ink.
- Electronic documentation:
- An electronic system must be used that can be understood by a third party.
- It is advisable to use a system with full audit trail.
- Electronic documentation systems include ELNs or LIMS solutions. Other electronic (commercially available or custom built) data capturing systems may also be used.
Extra care has to be taken:
Traceability of experimental data should be ensured by using the data recording platform (see item 3.1.2.1 Traceability of data and any person having impact on data).
PLEASE DO NOT FORGET
To train new researchers in your lab how to use the data recording platform of choice.
To provide the required infrastructure so that the platform of choice can be used properly (e.g. have spare lab notebooks or electronic work spaces available).
C. Resources
- Guidelines for SCIENTIFIC RECORD KEEPING in the Intramural Research Program at the NIH [1]
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Next item: 3.1.2 Procedures for how and when to record data
