What is a Clinical Trial?
Find out all about clinical trials.
Overview of clinical trial phases and timeline
Overview of clinical trial phases and timeline
Here we show a clinical trial timeline — including all phases, 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.
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Screening Visit
When you first attend the screening visit for phases 1-3, the study is explained in detail and you can ask any questions. If you decide to participate, the study nurse will review the informed consent form with you and ask for your signature and permission to proceed with the screening evaluations. Lasts 1-3 hours.
Screening Visit
When you first attend the screening visit for phases 1-3, the study is explained in detail and you can ask any questions. If you decide to participate, the study nurse will review the informed consent form with you and ask for your signature and permission to proceed with the screening evaluations. Lasts 1-3 hours.
- Ask any questions you may have
- Physical exam/evaluation
- Medical history review (including medication)
- Receive and review your trial journey book
- Review other trial-related literature
- Ask any questions you may have
- Both parties sign (or you take it home first — if/when you sign the consent form, evaluation tests and the sponsor documents are completed on your next visit.)
- Discuss trial safety, side effects, number of visits and financial considerations
- Depending on the trial protocol, these could include lab tests, X-rays, CT scan, physical exam, etc.
- Questionnaires on health, work issues, depression, coping mechanisms, managing your condition, etc.
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.
- Ask any questions you may have
- Physical exam
- Discuss medical history change
- Questionnaires on health, work issues, etc.
- Ask any questions you may have
- Discuss medical history change
- Discuss medication you are taking
- Learn about home monitoring
- Discuss medication dosing and home monitoring with the at-home diary (journalling to keep track of medication use)
- Pills, injections provided*, and either administered by coordinator/nurse or patient is taught how to self-administer
- Phases 1–3. In phase 4 observational trials : patients get their medication at a pharmacy through prescription.
- 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 will be informed by the study coordinator.
- Depending on the trial protocol and medical condition, these could include lab tests, X-rays, CT scan, physical exam, etc.
- Start journalling: 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.
Clinical Trial Visits
The number of your clinical visits will depend on the specifics and length of the study. There may be follow-up visits that include a brief physical exam (not generally in phase 4 observational studies), a review of your study medications and your symptoms and lab tests.
- Ask any questions you may have
- Physical exam if required
- Discuss medical history change
- Depending on the trial protocol and medical condition, these could include lab tests, X-rays, CT scan, physical exam, etc.
- Ask any questions you may have
- Discuss possible side effects
- Discuss medical history change
- Discuss medication you are taking
- Discuss and account for drug intakes; review your diary
- The informed consent form can be periodically updated during the trial (contact info, location change, side effects, etc.). If/when there are any changes or additions, you will be informed by the study coordinator.
- Questionnaires on health, work issues, etc.
- Receive trial treatment
- Pills, injections provided*, and either administered by coordinator/nurse or patient is taught how to self-administer
- Phases 1–3. In phase 4 observational trials : patients get their medication at a pharmacy through prescription.
- Continue journalling: enter medications, start/stop dates, dosages, reactions, health status, mood status, symptoms, etc. Complete any questionnaires that were not already completed at the study clinic.
Last Clinical Trial Visit
Similar to the other visits (except that home monitoring is over), this visit does not always mean the journey's
end — the trial may require follow-up visits. Ask when the results will be available and how you will be informed. While your part may be over, the clinical trial itself can last longer.
- Ask any questions you may have
- Physical exam if required
- Discuss medical history change
- Discuss treatment options
- 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 will be informed by the study coordinator
- Ask any questions you may have
- Discuss medication you are taking
- Discuss and account for drug intakes; review your diary
- Discuss medical history change
- Depending on the trial protocol and medical condition, these could include lab tests, X-rays, CT scan, physical exam, etc.
- Questionnaires on health, work issues, etc.
After the Clinical Trial
When your participation in the trial is completed, in some cases the research coordinator may arrange telephone follow-ups with you.
There may be other patients still participating, so when the trial is officially over, the results will be available on the site as soon as they have been made public.
