To document procedures, files, decisions and important steps of a research project.
- Documentation will help you manage your research project.
- Documentation promotes transparency, integrity and the quality of your data.
- A documented project is easily transferrable, e.g. to research assistants.
- Files and procedures of documented research are reusable.
There are different levels of research documentation;
- Documentation of the data (see Data management plan)
- Documentation of the research project
- Documentation regarding folder structure and file names, if necessary. Folder and file names should be self-explanatory when possible.
- Logs of important decisions, problems and solutions. See Logbook.
- Documentation regarding protocols, ethics, laws. This includes communication with relevant committees, such as the Medical-Ethics Committee.
- Documentation regarding project planning, such as a timeline, and minutes with action lists and decisions made
- A field guide that includes:
- A brief manual for using the administrative database;
- A detailed description of study flow (recruitment, inclusion, measurement, data collection);
- Relevant documents, such as standard messages for participants.
- Documentation regarding analysis, such as R markdown files, other R codes or SPSS syntaxes.
- To properly document all important steps of the research project
- to ensure/check whether all important steps are properly documented
Research assistant: N.a.
There are several aids to help you with a proper documentation:
- Checklist Documentation
- Please note, that there are stricter requirements (trial master file and eCRF e.g.) for Clinical Trials with pharmaceuticals and Medical devices that fall under GCP regulation/ WMO-high/medium risk.