Documentation

Aim

To document procedures, files, decisions and important steps of a research project.

Why

• 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.

Responsibilities

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.