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Trial Protocol Template
Clinical protocol template for inclusion criteria, endpoints, monitoring, and governance responsibilities.
templateEvidence status: active sourceUpdated 2026-02-15
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Section index
- 1) Trial Overview
- 2) Intended Use and Claims Under Evaluation
- 3) Study Design
- 4) Eligibility
- Inclusion criteria
- Exclusion criteria
- 5) Data Collection Plan
- 6) Endpoints
- Primary endpoints
- Secondary endpoints
- Safety endpoints
- 7) Sample Size and Power Inputs
- 8) Statistical Analysis Summary
- 9) Monitoring and Safety Oversight
- 10) Data Integrity and Governance
- 11) Acceptance Criteria
- 12) Appendices
--- doc_id: ASTRACBC-OCULAR-TRIAL-PROTOCOL-TEMPLATE title: Clinical Trial Protocol Template - Ocular Smartphone-Only SaMD version: v0.1-draft status: template owner: Clinical Validation audience: Clinical Ops, Biostatistics, Regulatory device_name: AstraCBC updated_at: 2026-02-15 ---
Trial Protocol Template
1) Trial Overview
- Protocol ID:
- Trial phase:
- Countries/sites:
- Sponsor:
- Principal investigator:
- Product build version:
2) Intended Use and Claims Under Evaluation
- Primary claim(s):
- Secondary claim(s):
- Explicit non-claims:
3) Study Design
- Design type (prospective, multicenter, blinded, etc.):
- Comparator/reference methods:
- Enrollment targets:
- Subgroup quotas:
- Device-family quotas:
4) Eligibility
Inclusion criteria
-
Exclusion criteria
-
5) Data Collection Plan
- Capture protocol (conjunctiva/sclera/pupil):
- Reference label timing windows (for example Hb +/-2h):
- Repeat measurements and adjudication workflow:
- Monitoring schedule:
6) Endpoints
Primary endpoints
-
Secondary endpoints
-
Safety endpoints
- QC failure rates
- abstain rates
- adverse event reporting pathways
7) Sample Size and Power Inputs
- Formula for proportion endpoints: `n ~= z^2 p(1-p)/w^2`
- Formula for continuous error endpoints: `n ~= (z*sigma/w)^2`
- Assumptions table:
| Parameter | Value | Source | |---|---:|---| | z | | | | p | | | | w | | | | sigma | | |
8) Statistical Analysis Summary
- Primary analysis population:
- Missing data handling:
- Subgroup analysis plan:
- Multiplicity control:
- Interim analysis rules:
9) Monitoring and Safety Oversight
- DSMB charter reference:
- Stopping rules:
- Unblinding conditions:
- Serious adverse event reporting timeline:
10) Data Integrity and Governance
- Audit trail requirements:
- Source verification strategy:
- Protocol deviation classification:
- CAPA workflow:
11) Acceptance Criteria
- Predefined pass/fail thresholds:
- Subgroup/fairness gates:
- Maximum allowed abstain rates:
- Required confidence bounds:
12) Appendices
- Site checklist
- Consent forms
- Case report forms
- Monitoring plan