How to conduct a risk assessment

Once you have created a trial, it is time to start with risk assessment.

  1. Enter a trial first. 
  2. A risk assessment of a trial starts with a "Draft" version and supposed to be "Released" when ready
  3. When entered a new study, explore the risk categories
  4. Each of the category consists of several questions, which supposed to guide you to risks
  5. When you read a question from a category, e.g., Blinding, it is supposed to guide you to relevant risks
  6. Each question must be connected to a certain risk(s)
  7. Document the risk, that you identified by adding new or using a suggestion (if available and suit your trial) from the central knowledge base:
  8. Add new risk(s) by pressing "Add another risk" if any further risks could be identified in the context of one question:
  9. Evaluate probability, impact, and detectability of each of the identified risks
  10. Apply criteria available as a tooltip for the objective assessment of each of the property
  11. Deactivate a question if it does not suit your trial or irrelevant
  12. Finish all the questions by connecting them with risks, providing risk assessments and/or disabling questions
  13. Release the draft after you finish your work

Note: The changes are saved in a database automatically if you make any changes, There is no extra button for that.