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Identity and source I recorded the official title and NCT or protocol identifier. I matched the sponsor, responsible party, local site, and contact through an independent source. I recorded the overall and local recruitment status, last-update date, and my check date. I understand the role of any recruiter, vendor, home-health company, laboratory, or app provider. Purpose and design I can explain the research question in one sentence. When applicable, I know every arm I could enter and the assignment ratio. When applicable, I know who is masked and how safety unblinding works. When applicable, I know whether the study uses placebo, active comparison, crossover, washout, cohorts, or an extension. I confirmed which design fields do not apply to this study. Procedures and time I have a visit-by-visit schedule with preparation and expected duration. I counted procedures, blood draws, imaging, devices, diaries, calls, home visits, shipping, and follow-up. I mapped travel, companion, childcare, work, accessibility, and recovery needs. I wrote the start and end date for each medication, food, activity, driving, reproductive, and other-study restriction. Risk, benefit, and alternatives I understand the known risks, uncertainty, and risk-reduction steps described in consent. I understand that direct benefit may be absent. I know the alternatives to participation that apply to me. I discussed personal medical questions with the study team and my clinician. Costs, payment, and injury I separated routine-care costs, research-paid costs, reimbursement, compensation, and incentives. I know what payment accrues after each activity and what happens after withdrawal or removal. I recorded payment method, timing, fees, tax-form expectations, and dispute contact. I found the study-related injury and emergency-care language and asked who may pay. Privacy, data, and specimens I distinguished research consent from HIPAA authorization when it applies. I know which records are requested, who receives them, and how they are transferred. I traced sponsor, vendor, laboratory, device, and cross-border data access. I understand required and optional specimen use, genetics, future research, recontact, commercial use, and withdrawal limits. Results and contacts I know which clinical, eligibility, research-only, and incidental findings may be returned. I know how urgent findings reach me and whether results can go to my clinician. I saved the research-team, after-hours, and participant-rights or IRB contacts. I know where aggregate results may appear after the study. Withdrawal I know how to stop the intervention and how to withdraw from other activities. I understand recommended safety follow-up, product or device return, and transition to regular care. I know what happens to existing data, future record access, and stored specimens. I know how accrued payment and approved reimbursement are closed out. Unanswered questions Record a question, the person or office to ask, and the answer or follow-up date. Keep names and health details out of this worksheet.
Question 1 Question 2 Question 3 The page code does not save or send checks or notes to Clinical Forage. A browser may restore form values. Use Clear checks and notes before leaving a shared device.
Route each unknown to the right person Study team: protocol, procedures, scheduling, payment, current site operations, and symptom reporting.Participant-rights or IRB contact: consent, pressure, rights, unresolved complaints, and privacy concerns.Your clinician: personal medical risk, treatment interactions, and alternatives.Insurer or billing office: routine-care charges and coverage.Tax or benefits professional: your reporting obligations and program rules.Medication safeguard
Do not prepare by changing treatment on your own Follow verified, written study instructions. Involve your clinician when fasting, washout, dose, contraception, or other preparation affects care.
Sources for this guide
References for the definitions, rules, and findings discussed above. The dates below record source checks; they are separate from the article’s edit date.
Office for Human Research Protections. Questions to Ask About Volunteering for a Research Study (opens in a new tab) . Checked September 5, 2026.U.S. Food and Drug Administration. Clinical Trial Participation (opens in a new tab) . Checked September 5, 2026.ClinicalTrials.gov. How to Read a Study Record (opens in a new tab) . Checked September 5, 2026.Office for Human Research Protections. Informed Consent FAQs (opens in a new tab) . Checked September 5, 2026.U.S. Department of Health and Human Services. HIPAA Privacy Rule and Research (opens in a new tab) . Checked September 5, 2026. 