Clinical Trial Enrollment Note (Pediatric Oncology)

Date/Time: [Date and time of documentation]

Location: [clinic / inpatient / telehealth]

Author: [Name, credentials, and study role (PI / sub-I / research nurse / CRC)]

Encounter Type: [screening visit / enrollment visit / interim discussion]

Trial Lifecycle Status: [pre-screening only / screening in progress / consent/assent completed not yet registered / registered/enrolled not yet randomized / randomized/assigned not yet started / Cycle 1 Day 1 planned/initiated]

Study Identification

Protocol Title: [Short title; full title if different]

Protocol Identifiers: [Sponsor protocol number]; [Cooperative group number if applicable]; [NCT number]

Sponsor/Funding: [Industry / Cooperative group / Investigator-initiated] — [Sponsor/funder name]

IND Status: [Sponsor-held IND / Investigator-held IND / Not applicable / Unknown]

IRB Study Number: [IRB number]

Protocol Version: [Version number] ([Version date])

Consent Version: [Version number] (IRB approval date: [Date])

Optional Sub-Study Consents:

• [Sub-study name] — [Version/date] — [Consented / Declined]
• (Repeat for each optional sub-study as applicable.)

Participant Context

[Enrollment-relevant clinical summary including: confirmed diagnosis with pathology status; disease status at enrollment; key molecular/risk features with source and date; prior therapies and timing relevant to washout; performance status with scale and date; comorbidities affecting eligibility/safety; central line status if protocol-required] (Omit details not relevant to eligibility.)

Eligibility Highlights

(Document only items required for this protocol. Use explicit status for each item: Met, Not Met, Pending, or Not Applicable. Include source documentation and dates. Do not infer normal values.)

Inclusion Criteria Highlights

• Age and weight requirements: [Met / Not Met / Pending / Not Applicable] — [Supporting data with dates and source]
• Diagnosis/subtype/stage/marker requirements: [Met / Not Met / Pending / Not Applicable] — [Pathology/molecular source and date]
• Disease status at enrollment: [Met / Not Met / Pending / Not Applicable] — [Definition per protocol and evidence/source with dates]
• Performance status threshold: [Met / Not Met / Pending / Not Applicable] — [Scale and score with date]
• Organ function thresholds:
  • Renal: [Met / Not Met / Pending] — [Creatinine/eGFR value and date; method/source]
  • Hepatic: [Met / Not Met / Pending] — [Bilirubin/AST/ALT values and date; source]
  • Cardiac: [Met / Not Met / Pending] — [EF/QTc and date; source]
  • Pulmonary: [Met / Not Met / Pending / Not Applicable] — [PFTs/O2 saturation and date; source]
• Recovery from prior therapy/toxicities: [Met / Not Met / Pending] — [Toxicity grades and date assessed; washout intervals satisfied]
• Other protocol-specific inclusion criteria: [Met / Not Met / Pending / Not Applicable] — [Supporting details and source]

Exclusion Criteria Review

• Active uncontrolled infection: [Met (no exclusion) / Not Met (exclusion present) / Pending] — [Source and date]
• Pregnancy/lactation status: [Met / Not Met / Pending / Not Applicable] — [Test/result/date]
• Prohibited concomitant medications: [Met / Not Met / Pending] — [Medication list review and date]
• Recent investigational agent exposure or conflicting trial enrollment: [Met / Not Met / Pending] — [Details and dates]
• Protocol-specific exclusions: [Met / Not Met / Pending / Not Applicable] — [Details and source] (Add items for each protocol-specific exclusion as needed.)

Overall Eligibility Status: [Eligible / Not Eligible / Pending] — [If Pending, list specific items awaited and expected dates]

Baseline Assessments

(Summarize protocol-required baseline evaluations. For any missing item, explicitly document Pending, Not Resulted, Scheduled, Not Applicable per Protocol, or Not Performed with explanation.)

Disease Evaluation

• Imaging: [Modality and anatomic sites] — [Date] — [Completed / Pending / Scheduled / Not Applicable] — [Source/report location]
• Bone marrow: [Date] — [Result summary if required] — [Completed / Pending / Not Applicable] — [Source]
• CSF: [Date] — [Cytology/cell count if required] — [Completed / Pending / Not Applicable] — [Source]
• Staging/risk stratification inputs: [Items required] — [Source(s) and dates] — [Calculated stage/risk group if applicable]

Safety Assessments

• Vital signs and anthropometrics: [Date] — Height [value], Weight [value], BSA [value] — [Meets protocol thresholds: Yes / No / Not Applicable]
• Key laboratory values: [Date] — CBC, CMP, LFTs, Creatinine/eGFR, Coagulation [values or summary] — [Meets thresholds: Yes / No] — [Source]
• Cardiac testing: ECHO EF [value] [Date]; ECG QTc [value] [Date] — [Meets thresholds: Yes / No] — [Source]
• Other protocol-specific tests: [Audiology / Pulmonary function / Viral serologies / Ophthalmology / Other] — [Date] — [Completed / Pending / Scheduled / Not Applicable] — [Source]

Baseline Medications

• [Active medication list relevant to protocol interactions with doses/frequencies and start/stop dates if relevant]
• Prohibited medication review completed: [Yes / No] — [Actions taken if prohibitions identified]

Baseline Symptoms

[Concise inventory of pre-existing symptoms/signs with CTCAE grade if required and onset/chronology if relevant] (Include only items present prior to study treatment to prevent misclassification as treatment-emergent.)

Consent Process

(Document who, what, when, and how. Ensure the person obtaining consent is authorized per IRB delegation.)

Date/Time of Consent Discussion: [Date and time]

Person Obtaining Consent: [Name, role] (Confirm authorized per IRB delegation.)

Persons Present: [Patient]; [Parent(s)/Guardian(s) with relationship]; [Interpreter with ID if used]; [Witness if required]; [Others]

Method: [in-person / video] — [paper / electronic signature] — [Language] — Interpreter services: [Yes with details / No]

Parental Permission: [One parent signed / Both parents signed / Legal guardian signed] (Document guardianship status if applicable.)

Assent Status: [Obtained / Waived by IRB / Not required due to age / Not capable due to clinical condition] — [Brief explanation if waived or not capable]

Consent Artifacts: Signed main consent: [Yes / No]; Signed assent obtained or waived: [Yes / No]; Copies provided to family: [Yes / No]

Optional Sub-Studies: [List each with Consented or Declined]

Key Elements Discussed: Research nature and purpose; randomization/placebo if applicable; foreseeable risks and potential benefits; alternatives to participation; confidentiality and monitor/auditor access to records; voluntary participation and right to withdraw without penalty.

Consent Discussion Narrative: [2–3 sentence summary of the interaction, questions asked, how understanding was assessed (e.g., teach-back), and the decision reached]

Study-Specific Procedures Prior to Consent: [None / Performed under standard-of-care / Performed under IRB-approved pre-screening authorization] — [Details if applicable]

Randomization and Stratification

(Include this section only for randomized trials. Maintain blinding: do not document treatment assignment in blinded trials.)

Randomization Status: [Not applicable / Pending / Completed] — [Date/time if completed]

Randomization Method: [Central web-based system / Other]

Stratification Factors:

• [Factor name]: [Participant value] — [Source and date]
• (Repeat for each factor required by protocol.)

Treatment Assignment: [Open-label: Assigned arm] / [Blinded: Randomization completed; assignment blinded to clinical team; emergency unblinding procedures acknowledged]

Study Schedule and Next Steps

• Remaining screening tasks: [List with planned/expected dates within protocol windows]
• Anticipated Cycle 1 Day 1: [Approximate date or window] (Subject to eligibility confirmation and scheduling.)
• Premedication/admission planning: [Requirements and timing]
• Visit cadence overview: [Early cycles vs later cycles visit/lab frequency; imaging frequency; approximate total study duration]
• Participant responsibilities: [Diaries / temperature logs / medication adherence / questionnaires / device care]
• Research-only procedures: [PK draws, optional biopsies, central imaging review, other] (Describe at high level.)

Orders and Actions

• Orders placed today: [Screening/baseline labs, imaging, procedures, study drug preparation, other]
• Research coordination actions: [Registration submitted / Specimen kits ordered / Scheduling requests sent / Pharmacy notified / Source templates prepared / Other]
• Enrollment Status: [Green / Yellow / Red] — Green: all enrollment steps complete, ready to proceed; Yellow: [list pending items, do not start study drug until resolved]; Red: [screen failure or consent not obtained, document alternate plan]

Discussion Summary

[2–4 sentence summary of patient/family questions, key concerns addressed, and explicit decision to enroll, defer, or decline; if deferring or declining, document reasons if volunteered; include direct quote for pivotal decisions if appropriate]