3.1.2.2 Process for witnessing of records
A. Background & Definitions
Witness: An individual at the research unit (and/or is under confidentiality) who did not participate in the design and execution of the experiment (and someone who won't be a co-inventor of any invention resulting from the experiment) but is knowledgeable of the subject matter and understands the experiment; preferably such an individual also observed all or part of the performance of the experiment.
Witnessing of experiments is important to safeguard patents and intellectual property.
B. Guidance & Expectations
- The author (i.e. the scientists who performed the experiments) should review and ensure completeness of the activity description and the data set.
- The author should sign the record and archive the data at the completion of the activity.
- A witness should review the documentation and sign the record.
- Expectation: Each witness must read and understand what is written in the experimental record, and therefore should have an appropriate technical or scientific background and experience to understand the experimental design, resulting data and conclusions.
- Witnessing is expected to occur in a timely manner (e.g. within 14 days or 1 month of experimental conduct).
Extra care has to be taken:
- If any changes are made after the witness signs the experimental record, the witness must acknowledge these changes and document this by initialing and dating where the changes were made.
PLEASE DO NOT FORGET
- Whether using paper or electronic notebooks, it is critical that each page of the notebook is signed, dated and witnessed.
For paper-based notebooks, all blank space should be filled (either by writing till the end of each page or by crossing-out unused space). Witnessing does not replace a thorough quality control (QC) review of the data (to ensure reported results are accurate and can be reconstructed from the raw data).
C. Resources
- Quinn G (2017) Patent Drafting: Understanding the Enablement Requirement [1]
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