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;

  1. Documentation of the data (see Data management plan)
  2. 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.

Executing researcher:

  • To properly document all important steps of the research project

Project leader:

  • to ensure/check whether all important steps are properly documented

Research assistant: N.a.

How to

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.