Managing Sponsored Projects
UM SPA, February 2008 |
Chapter 4: Setting up the project
Section 4.2: Recordkeeping
- Delegation of Authority
- Documenting the work
Delegation of Authority
Before purchases are made the PI should delegate in writing the authority to make purchases. This document must list the individuals by name and must be signed by the PI. Keep this document in the project files for audit purposes.
Documenting the work
The research and the laboratory notebook
Good scientific practice includes keeping clear, legible records and data that support the validity of the work and conclusions. Such documentation is also important for claiming credit for inventions.
United States patent law relies on a "first to invent" rule-the person who invented the item first gets the patent, rather than the person who files the patent application first. If there is a dispute, laboratory notebooks play a key role in establishing what was done and when it was done. The following guidelines will help the Patent Office determine the reliability of these records:
How to record
- Write legibly and do not scribble.
- Use indelible ink instead of pencil.
- Use a bound notebook with numbered pages rather than a looseleaf notebook where pages can be added or removed.
- Rather than tearing out pages to make corrections, cross out the data, initial and date the changes, and explain why the corrections are being made.
- Record entries consecutively rather than skipping spaces or pages. If pages or lines are skipped, draw a line through them and initial/date them.
- Always define somewhere in the book any acronyms or abbreviations that are used.
What to record
Since ideas are proof of conception, record ideas as well as experiments. This includes ideas for future experiments.
Make the notebooks easy to read for third parties-keep records of experiments complete and self-explanatory, include a table of contents for each notebook.
Procedures can be cross-referenced to save space.
Avoid recording that the result was "obvious" or the experiment "abandoned." These words have legal meanings.
How to record
Rather than erasing or tearing out pages to make corrections, cross out the data, initial and date the changes, and explain why the corrections are being made.
Who signs
The person who worked on the experiments and recorded them must sign and date the entries.
A noninventor should witness the entries, someone who did not work on the project but knows about and understands it enough to testify about it.
When to sign
Witnesses should sign as soon as the experiment has been conducted in order to convince the Patent Office that the notebook is credible and reliable.
How to sign
The recorder signs: "Recorded by me, ___" and the date.
The witness signs: "Witnessed and understood by me, ___" and the date.
Retention of records
Since the notebooks and any other documentation are a product of the work, they must stay on the premises.
Electronic records
Research data represent a great deal of work and effort. When using electronic records, maintain those data on University servers that are secure and backed up regularly.
Computer records can be easily altered. To show authenticity and reliability,
- Electronic records must be reproducible in electronic form or as paper printouts, including audit trail and metadata.
- A human readable transaction log or audit trail, created by individual entries, must be implemented. The log should include creation, update and deletion information for electronic records or data.
- Electronic records must be retrievable through the retention period.
- System access must be limited to authorized users and the system must authenticate each user upon login.
Controls should ensure that the system date and time are correct.
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