Both the AMC and the VUmc aim to carry out basic and translational research of the highest quality. The regulations described here are intended to improve the reliability and reproducibility of basic and translational biomedical research, and to prevent scientific misconduct.
Basic and translation biomedical research is performed in dedicated laboratories following strict rules, regulations and laws. In addition:
Scientific research is performed in the framework of projects that should contain a transparent formulation of the aim of the research, following a critical analysis of the literature and any other relevant data. The principal investigators are responsible for the quality, accuracy, traceability and reproducibility of all research findings obtained within their research projects.
Many different diagnostic laboratories at both the AMC and the VUmc have adopted quality control systems and are accredited according to, for example, CCKL or ISO 15189 standards. Although it is not mandatory for basic and translation biomedical research laboratories to comply with these CCKL standards and obtain accreditation, it is very useful to organize the research according to those rules and regulations. Imposing these rules and regulations in the laboratory facilitates patent applications and increases funding opportunities from national and international foundations and consortia, and from biopharmaceutical companies.
Strict rules for basic and translational research have been laid down in specific acts. These comprise, for example, strict rules for the use of radioactive material and genetically modified organisms, and the handling and use of laboratory animals.
Radioactive material, see: www.agentschapnl.nl
In order to keep track of the research performed, biomedical research laboratories should maintain a proper project administration. The project administration must include at least the following items.
The CCKL rules and regulations can serve as a guideline for proper project administration.
Alternatively, electronic laboratory management systems may be used. For such an approach, do not use computer programs, like Word and Excel, which allow entries and dates to be altered without traceability. For information about electronic laboratory notebooks (ELNs), see for example:
In addition to keeping a laboratory notebook in which all protocols are written down, it is recommended to keep a database of/binder containing all standard operating procedures (SOPs) that are followed in the laboratory. A SOP is defined as a 'detailed, written instruction to achieve uniformity of the performance of a specific function'. In basic and translational research, this often refers to a detailed protocol on how to perform a specific experiment. A SOP should address the following items:
4. Principle of the test
6. Reagents and solutions
9. Standard procedures
12. Quality control (procedure/samples)
13. Disposal of chemicals and samples
14. Additional documentation
16. Literature references
All SOPs should be numbered and stored both in a central place (or on a website) and in the laboratory. SOPs should be approved by the principal investigator and receive regular updates.
Some 20 years ago, clinical laboratories began setting up an accreditation system to guarantee and demonstrate the quality of their processes and the results of their tests. The Foundation for the Promotion of the Quality of Laboratory Work and the Accreditation of Laboratories in the Health Service (Coördinatie Commissie ter bevordering van de Kwaliteitsbeheersing op het gebied van Laboratoriumonderzoek in de Gezondheidszorg; CCKL) was initiated for this purpose. The CCKL rules require the implemented quality system to be laid down in a manual that briefly sets out the laboratory's activities and organization, procurement of resources, quality of the facilities, initial and subsequent training of staff, servicing and calibration of apparatus and equipment, and how results are reported. All this has to comply with ISO 15189, an international standard for laboratories. The CCKL explains how this applies to Dutch laboratories in its Practice Guide (Praktijkrichtlijn ).
Even though accreditation is an option for both translational and basic science laboratories, the guidelines and rules can be a great aid when organizing your research efforts.
For more information: www.cckl.nl
Recording ideas, inventions, experimentation records, observations and all work details in a notebook is a vital part of any laboratory process. Careful attention to how you keep your notebook can have a positive impact on the patent outcome of a pending discovery or invention.
The following are some general recommendations to help you keep more efficient and accurate notebook entries. Remember, however, that these are simply a suggested set of guidelines. Only your attorney can supply the exact guidelines you should follow in order to satisfy specific legal requirements. That is why we recommend that you consult your legal counsel.
Your notebook is a vital record of your work whether it is for patent purposes, legal records or documenting drug research under FDA guidelines. The notebook can help you prove:
a. Exact details and dates of conception
b. Details and dates of reduction to practice
c. Diligence in reducing your invention to practice
d. Details regarding the structure and operation of your invention
e. Experimentation observations and results
f. A chronological record of your work
g. Other work details.
Follow a few simple rules of thumb
Remember to treat your notebook as a legal document : it records the chronological history of your activities. The following guidelines should help you maintain the consistent and accurate entries needed for future legal purposes.
Documenting patent activities
A primary purpose of a notebook is to document work that may be patentable. To support patent activities, it is necessary to provide clear, concise, chronological entries with specific dates. To rely on these dates, you must have at least one non-inventor corroborate that the events actually happened and that he/she understood your invention by signing and dating the 'Disclosed to and understood by' signature blocks.
Your notebook should help you document and prove:
A non-inventor colleague should corroborate each of these events/facts by signing the 'Disclosed to and understood by' blocks on the relevant pages.
For more information: www.cckl.nl