Understand What a Clinical Trial Is

• I know this is a research study, not a guaranteed treatment
• I understand there are multiple phases to test safety and effectiveness
• I’ve learned the difference between a trial and standard care

 

Know the Purpose of the Study

• I’ve read the trial’s goal and what it hopes to discover
• I understand what condition or disease the trial is focused on
• I know whether I’ll be receiving a new treatment or a placebo

 

Review the Eligibility Criteria

• I meet the inclusion requirements (age, condition, medical history, etc.)
• I’ve been screened and approved for participation
• I’m aware I can be excluded for certain health conditions or medications
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Review the Informed Consent Document

• I’ve received a full explanation of the trial, including risks and benefits
• I’ve had a chance to ask questions and get clear answers
• I’ve signed the consent form voluntarily, with no pressure
• Understand the Risks and Safeguards
• I know what possible side effects or complications may occur
•     I’m aware the study is reviewed by an Institutional Review Board (IRB)
•     I know I can withdraw at any time for any reason

 

Know What Participation Involves

• I understand how long the trial will last and how often I’ll need to go in
• I’ve been told what tests, medications, or procedures I’ll receive
• I know who to contact if I have a problem during the trial

 

Evaluate Practical Considerations

• I’ve asked about travel, time off work, and any costs or compensation
• I know where the trial is being held and what follow-up is required
• I’ve discussed this option with my doctor or healthcare team

 

Prepare Emotionally and Mentally

• I feel comfortable with the unknowns and potential outcomes
• I’ve discussed this with loved ones or a support system
• I believe I’m making an informed, empowered decision
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