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» Biotech R&D Audit Checklist
Biotech R&D Audit Checklist
STEP 2 OF 2
Do you have records/ documents that demonstrate you carried out the experiment/s for your registered core activity?
Can you explain how you established that the outcome of each experiment could not be determined in advance? (you will need to comment on the knowledge gap that existed when the registered core activity was undertaken.)
Can you outline what new knowledge, in the form of new or improved products, processes or services, was produced as a result of carrying out the project?
Do you have documents to demonstrate that a knowledge gap existed at the commencement of the project?
Can you explain how the new knowledge is more than a simple progression from what is already known or how it is more than applying existing knowledge in a different context or location?
In order to establish that your experiments for the registered core activity employed the scientific method, you will need to answer the following questions:
Which of the following scientific principles was your project based on (please tick all that apply):
Can you describe the hypothesis that the experiment/s was employed to test?
Can you describe the results of the experiments and the conclusions you reached?
For biotech developments claimed as a core activity, can you describe the hypothesis, experimentation, observation, evaluation and conclusions?
Can you provide documentation which support your core and supporting activities? For example, if this involved the development of Phase I, II or III clinical trials, the records should show how the company researched and established that no existing products offered a suitable solution and the reasons why.
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