What you can/shall store in ELN
Research documentation at KI and within KI ELN should be done in such a way that it is possible for co-workers (and external peers if necessary) to follow and review the research.
What you SHALL document in ELN irrespective of the type of research you are performing:
Research documentation within KI ELN should cover the intellectual and practical sides of research:
- Background and Aim: What is your specific scientific question?
- Data collection: Describe how you collect your data/which datasets you are working on
- Processing and analysis of data: Include calculations and statistical analyses
- Methods: Protocols, instructions, validation
- Results: raw and processed data
Regarding results, they can also be stored outside ELN in an authorized system for research data storage (such as Onedrive or a KI server). In that case a reference to where the results are saved must be provided in ELN.
Files bigger than 50 MB can not be uploaded to ELN. In that case, they should be saved outside ELN in an authorized system for research data storage (such as Onedrive or a KI server) and a reference to where the files are saved must be provided in ELN.
All this information can be uploaded to "experiments" (folders) that are saved under a project.
Below you can find a few examples of content that might be relevant to upload to ELN depending on the type of research you are conducting (experimental / epidemiological / clinical):
Examples of what to save in ELN if you are performing experimental research:
Methods
- laboratory apparatus used
- Standards/controls used
- Programs/scripts/statistical analysis used
- Detailed experimental protocol
Materials
- Antibodies, chemicals, buffers, solutions, kits: including lot/batch numbers, catalogue numbers, dilutions, etc
- Sample species
- Sample type: e.g. homogenate, biopsy, purified DNA
Data
- Observational data: captured in real time, i.e. sensor readings
- Experimental data: from lab equipment, i.e. chromatographs, blots, images, NGS data, flow cytometry files
- Simulation data: generated by computer models
Examples of what to save in ELN if you are performing epidemiological research:
Data and Metadata
- Upload the final study population needed to run the statistical analyses
- If data is not uploaded, provide a statement of where it is stored and who the contact person is
- Upload any relevant metadata such as code books or variable lists
Analysis plan
- Upload versions of the analysis plan
- Upload study protocols
Programs and logfiles
- Upload the statistical programs used to create the data
- Upload descriptive analysis
- Upload main results
- Upload review programs
- Attach output (log files, figures, tables)
Examples of what to save in ELN if you are performing clinical research:
Investigator’s Brochure
- List of abbreviations
- Summary
- Physical, chemical, pharmaceutical properties of medicinal products
- Data from non-clinical studies
- Data from clinical studies
- References
Clinical study protocol
- Introduction
- Objectives
- Study duration
- Number of subjects
- Informed consents
- Subject selection criteria: inclusion/exclusion
- Study plan
- Protocols/Procedures
- Endpoints definition
- Safety Reporting
- Adverse events
- Management of dropouts
Study progress reports
Informed consent forms
Case report forms
Data information
- Derived/compiled data, i.e from registries, databanks
- Laboratory test readouts
- Motor/non-motor test results
- Information retrieved from medical records
- Questionnaires
- Interviews
Statistical analyses / Results
Irrespective of the type of research you are performing you can upload copies of the following in ELN:
- Ethical approvals: You can upload a copy of the signed ethical approval for the study as well as amendments (if applicable)
- Meeting minutes: You can upload a copy of all meeting minutes with decisions clearly described
- Contracts and agreements: You can upload a copy of Material Transfer Agreements, Data processing Agreements
- Data management plans
- Funding documents: You can upload a copy of grants applications, financial reports
- Applications for access to material (e.g. registry data/biobank samples)
- Project plans
- Correspondence of principal importance
- Publications: You can upload circulated manuscript versions, correspondence with the journal and final published version
- Posters/Abstracts: You can upload underlying data, figures, correspondence and final version of the abstract
All these documents can be saved in experiments under a project.
For example, you can create an experiment (a folder) called ethical approvals and there you can upload your ethical approvals
Bear in mind that most of the "administrative" documents above (such as ethical approvals ans contracts) must be registered at the KI diary as per KIs record schedule document.