Checklist Documentation

An aid to document all important steps of a research project.
Folder structure and File names
  • Are folders and files stored on the network and accessible for all project members?
  • Is a clear version numbering used in your file names?

Protocols, ethics, laws
  • Is your project registered with the “Centraal Meldpunt Gegevensbescherming”?
  • Are the application, communication and reviews of the ethical committee (Medical Ethical review Board: METc or Ethics Review boards or committees; ERB) properly archived?
  • Are changes (amendementen) in the research protocol accorded by the METc?
  • Is your project registered with the Privacy officer (Functionaris Gegevensbescherming)?

Project Planning and work deliberation
  • Is a project plan drawn and kept up to date?
  • Are all decisions with impact on your project properly noted?

  • Is a general index maintained?
  • Does the index contain decisions with impact on content and or execution?
  • Are references to deliberations on decisions given?
  • Are references to other (sub)logbooks registered in the index?

Inclusion of study participants
  • Are possible changes in the in- and exclusion criteria documented, including the reasons why?
  • Do you register non-responders, dropouts and if possible the reason for non-response or drop out?
  • Is the randomization procedure written down, including possible changes?
  • Are the arrangements with the independent person who performs the randomization documented?

  • Are the choices made in the selection of questionnaires well documented? E.g.: validity, reliability, translation, suitability for your outcomes and your study population
  • Don't forget to document why questionnaires are rejected.

Physical measurement instruments
  • Have the desired accuracy, measurement range and error been determined?
  • Does the instrument satisfy these criteria?
  • Has the instrument been calibrated and has its functioning been regularly checked?
  • Has this been clearly recorded (in a logbook)?
  • Is there a clear measurement protocol?
  • Has the inter- or intra-observer reliability been determined?

Data Collection
  • Are research assistants trained according to a training protocol?
  • Is noted who has trained the assistants?
  • Are problems and their solutions recorded in a logbook?
  • Is the intra- and inter-observer reliability documented?

Data processing
  • Is the reliability of the data entry checked by comparison of a (partial) double data entry?
  • Are the raw data stored in a separate map and is a copy delivered to the research data management department?
  • Is the data cleaning clearly documented (e.g. in a syntax)?
  • Are cleaned data recognizable?
  • Has the data transformation been documented (e.g. in a syntax)?
  • Is ensured that transformations are reversible?
  • For qualitative research: Has the coding process been well documented?

Analysis and Publication
  • Has an analysis plan been created for each publication, including a clear research question?
  • Are transformed or changed data files saved as a new file with a different name?
  • Are the final versions of the publication, analysis plan, annotated syntax and data files used all stored together in one folder?

  • Is all the documentation properly archived and/or handed over to the Principal Investigator?
  • Logbooks, documentation of the analysis, and articles/reports handed over to the Principal investigator’s?
  • At the end of a study the researcher needs to properly archive all aspects of the study to meet requirements from relevant regulations and guidelines (e.g. AVG/GDPR, WMO, NFU guidelines) codes of conduct, and, where applicable, funder’s requirements.