Trial Overview & Journey Sample

Here we show a clinical trial timeline — what a participant’s trial journey looks like, from the beginning to when they get the results. Each visit ‘milestone’ is explained: just click on the visit name for all the details.

BASELINE VISIT

If the screening tests show that you qualify, the study coordinator will schedule an entry — or baseline — visit.

When you attend this visit, the first step in your trial, you’ll receive your study medication and the dosing will be reviewed with you. There will also be lab tests done to get baseline values before starting your study treatment.

  Meet with the specialist
  • Ask any questions you may have
  • Physical exam
  • Discuss medical history change
  Complete sponsor documents
  • Questionnaires on health, work issues, etc.
  Meet with the study coordinator
  • Ask any questions you may have
  • Discuss medical history change
  • Discuss medication you are taking
  • Learn about home monitoring
  Receive trial treatment
  • Discuss medication dosing, and home monitoring with the at-home diary (journaling to keep track of medication use)
  • Pills, injections provided*, and either administered by coordinator/nurse, or patient is taught how to self-administer

* Phases I-III. In phase IV observational trials, patients get their medication at a pharmacy through prescription.

  Discuss informed consent form

The informed consent can be periodically updated during the trial (contact info, location change, side effects, etc.). If/when there are any changes or additions, you’ll be informed by the study coordinator.

  At-home monitoring

Start journaling: enter medication start/stop dates, dosages, reactions, health status, etc. into your diary. Complete any questionnaires that were not already done at the study clinic.

  Baseline testing
  • Depending on the trial protocol and medical condition, these could include lab tests, X-rays, CT scan, physical exam, etc.