Clinical Trial Screening/Enrollment Note

Header Fields

• Note Type: [Pre-screening / Screening Visit / Consent Visit / Enrollment/Baseline Visit / Screen Failure / Re-consent]
• Date/Time of Encounter: [Date and time] (If consent obtained today, also record sign time in Informed Consent section.)
• Location: [Clinic / Infusion center / Inpatient / Telehealth / Phone] (If telehealth or phone, document exam limitations in Encounter Context.)
• Author: [Name, role, and credentials]
• Data Sources Reviewed: [Sources with relevant dates] (Include patient interview, EHR chart review, outside records, imaging, labs as applicable.)

Study Identification

• Study Title: [Full title]
• Short Name/Acronym: [Short name or acronym]
• Sponsor: [Sponsor name]
• Protocol Number: [Protocol number]
• Protocol Version/Date: [Version and date] (If unknown, enter "Not available—will reconcile" and add an addendum.)
• IRB Identifier: [IRB number]
• IRB Approval Status: [Approved / Pending / Expired / Other]
• ClinicalTrials.gov NCT Number: [NCT number] (If applicable.)
• IND/IDE Identifier: [IND or IDE number] (If applicable.)
• Investigational Product/Device Name: [Name]

Encounter Context

[Brief narrative explaining reason for research evaluation, referral source, relevant clinical context, and today's purpose] (1–3 sentences. Include diagnosis, stage, and line of therapy as relevant. State purpose: eligibility review, consent discussion, baseline assessments, enrollment decision, or screen failure determination. If telehealth or phone, explicitly note limitations such as physical exam not performed.)

Informed Consent

• Consent Status: [Not approached / Approached—declined / Discussed—decision pending / Consented / Re-consented / Consent withdrawn] (If declined or withdrawn, document timing, reason if offered, and next clinical steps.)

(Complete the following only if Consented or Re-consented.)

• Consent Discussion Conducted by: [Name and role]; Others Present: [Names and relationships]
• Interpreter: [None / Language and interpreter ID]
• Consent Format: [Paper / Electronic]
• Consent Form Version/Date: [Version and date] (If unavailable, enter "Not available—will reconcile" and complete an addendum.)
• Optional Substudies Consented: [Biospecimen / Genetics / Optional imaging / Future contact] (List those consented; omit those declined or not applicable.)
• Date and Time Subject Signed: [Date and time] (If unknown, enter "Not available—will reconcile".)
• Copy of Signed Consent Provided to Subject: [Yes / No] (If No, document plan to provide.)

Key Elements Confirmed Discussed: Research nature and purpose; expected duration; key procedures including invasive and optional components; material risks and expected benefits including possibility of no direct benefit; alternative options; confidentiality approach; costs and coverage; compensation for research-related injury; voluntary nature and right to withdraw. (Confirm all were addressed; elaborate only if specific concerns arose.)

Patient Questions and Responses: [Summary of questions and how answered] (Include direct quote only if pivotal decision or concern expressed.)

Assessment of Understanding: [Basis and clinician assessment] (Basis may include teach-back, paraphrase, or question responses.)

Decisional Capacity/Coercion/Vulnerability: [Concerns and actions taken / No concerns identified] (Document any concerns and mitigation steps taken.)

Eligibility Determination

• Screening Stage: [Pre-screening / Screening in progress / Screening complete—awaiting confirmation / Eligible—ready to enroll / Screen failure]

(Document 5–10 key gatekeeper criteria. Do not infer eligibility. Mark pending items with plan and target date. For criteria requiring investigator judgment, document reasoning explicitly. For screen failure, document only disqualifying criteria with sufficient detail.)

• Criterion: [Description or protocol criterion number]
  • Status: [Met / Not met / Pending]
  • Evidence: [Test name, value, date, and source]
  • Investigator Judgment: [Explicit reasoning with cited evidence] (Include only if criterion requires clinical judgment.)
• (Add additional criteria as needed.)

Prohibited Medications and Washout: [Relevant medications, dates stopped, washout status, and target completion date] (If pending, document plan and responsible party.)

Reproductive Status: [Pregnancy test result and date / Not applicable]; [Contraception method if required]; [Counseling documented: Yes / No] (Do not infer negative pregnancy status without documented test result.)

Baseline Status and Assessments

(Include trial-relevant baseline information only. Label patient-reported versus clinically observed findings.)

• Problem-Focused Symptom Inventory: [Symptom, severity, onset, and source] (Focus on symptoms relevant to endpoints or safety.)
• Baseline Conditions: [Conditions that may overlap with treatment-emergent events]
• Performance Status: [ECOG / KPS] — [Score] — [Date]
• Trial-Relevant Medications and Allergies: [Medications with doses; allergies with reactions; source]

Protocol-Required Baseline Assessments: (Clearly label research-only assessments to prevent billing confusion. Note whether external records meet protocol standards.)

• Assessment: [Labs / Imaging / ECG / PRO / Biopsy / Other]
  • Window Requirement: [Timeframe]
  • Status: [Completed / Scheduled / Ordered / Pending / Not required]
  • Date and Key Result: [Date and value or "see report"]
  • Follow-up Responsible Party: [Name and role]
  • Research-only: [Yes / No]
• (Add additional assessments as needed.)

Plan

• Current Enrollment State: [Screening / Registered / Enrolled / Randomized / Treatment start planned]
• Key Planned Dates: [Target enrollment date; Treatment Day 1; Randomization date if applicable]
• Outstanding Eligibility Items: [Item, deadline, responsible party, and plan to resolve] (Add items as needed.)
• Start-of-Treatment Prerequisites: [Washout completion; Baseline review; Contraception counseling; Other prerequisites]
• Orders to Place: [Order, responsible party, and due date]
• Next Visit: [Visit type, date/time, location, and purpose]

(If not eligible or decision pending, document follow-up plan and timeframe instead of enrollment plan.)

Protocol Deviations

(Include this section only if a deviation or exception occurred. Omit entirely if none.)

• Description: [What occurred and which criterion or window involved]
• Timing: [Prospective exception / Retrospective deviation]
• Mitigation Taken: [Actions to address impact]
• Notifications Required: [Sponsor / IRB / None] — [Date submitted or planned]

(This note serves as source documentation for clinical trial conduct supporting FDA and ICH GCP compliance. Use explicit placeholders such as "Pending" or "Not available—will reconcile" rather than omitting required data. Do not infer eligibility or clinical states without documented evidence. Create an addendum if information is reconciled after note completion.)