Clinical Trial Protocol Compliance Analysis
Report Generated: January 12, 2026
Severity Breakdown: HIGH: 7, MEDIUM: 5
Unacceptable compliance. The protocol has critical gaps that require major revision before regulatory submission.
The protocol should specify inclusion and exclusion criteria for subject selection.
Sections Searched: 1.0, 1.1, 2.0, 2.1, 2.2, 3.0, 3.1
Synonyms Tried: Inclusion Criteria, Exclusion Criteria, Subject Selection, Eligibility, Eligibility Criteria, Selection Criteria
Pages Checked: 1, 2, 3
The protocol should specify efficacy parameters and assessment methods.
Sections Searched: 1.0, 1.1, 2.0, 2.1, 2.2, 3.0, 3.1
Synonyms Tried: Efficacy, Endpoints, Primary Endpoint, Efficacy Assessment, Outcome Measures, Assessments
Pages Checked: 1, 2, 3
The protocol should specify safety parameters, adverse event reporting, and safety monitoring procedures.
Sections Searched: 1.0, 1.1, 2.0, 2.1, 2.2, 3.0, 3.1
Synonyms Tried: Safety, Adverse Events, Safety Assessment, AE Reporting, Safety Monitoring, Toxicity
Pages Checked: 1, 2, 3
The protocol should include statistical methods, sample size calculation, and analysis plan.
Sections Searched: 1.0, 1.1, 2.0, 2.1, 2.2, 3.0, 3.1
Synonyms Tried: Statistics, Statistical Analysis, Sample Size, Statistical Methods, Analysis Plan, Statistical Plan
Pages Checked: 1, 2, 3
The sponsor should ensure adequate trial monitoring. For certain trials, a Data Safety Monitoring Board (DSMB) should be established.
Sections Searched: 1.0, 1.1, 2.0, 2.1, 2.2, 3.0, 3.1
Synonyms Tried: DSMB, DMC, Data Monitoring Committee, Safety Monitoring Committee, Data Safety Monitoring, Independent Safety Committee
Pages Checked: 1, 2, 3
The protocol should describe the informed consent process and include consent form templates.
Sections Searched: 1.0, 1.1, 2.0, 2.1, 2.2, 3.0, 3.1
Synonyms Tried: Informed Consent, Consent Process, Consent, ICF, Consent Form, Subject Consent
Pages Checked: 1, 2, 3
The protocol should describe the ethics committee review process and IRB approval requirements.
Sections Searched: 1.0, 1.1, 2.0, 2.1, 2.2, 3.0, 3.1
Synonyms Tried: Ethics Committee, IRB, Institutional Review Board, Ethics Review, Ethics Approval, IRB Approval
Pages Checked: 1, 2, 3
The protocol should include a title page with protocol title, version number, and date.
Sections Searched: 1.0, 1.1, 2.0, 2.1, 2.2, 3.0, 3.1
Synonyms Tried: Title Page, Protocol Title, Version Control, Protocol Version
Pages Checked: 1, 2, 3
The protocol should describe the treatment regimen, dosing schedule, and administration procedures.
Sections Searched: 1.0, 1.1, 2.0, 2.1, 2.2, 3.0, 3.1
Synonyms Tried: Treatment, Dosing, Drug Administration, Treatment Regimen, Dosing Schedule, Study Treatment
Pages Checked: 1, 2, 3
The sponsor should implement quality control and quality assurance systems.
Sections Searched: 1.0, 1.1, 2.0, 2.1, 2.2, 3.0, 3.1
Synonyms Tried: Quality Control, Quality Assurance, QC, QA, Quality Management, Quality Systems
Pages Checked: 1, 2, 3
The sponsor should use data management procedures to ensure data quality and integrity.
Sections Searched: 1.0, 1.1, 2.0, 2.1, 2.2, 3.0, 3.1
Synonyms Tried: Data Management, Data Handling, Data Collection, EDC, Case Report Forms, CRF
Pages Checked: 1, 2, 3
The protocol should reference essential documents required for trial conduct and regulatory submission.
Sections Searched: 1.0, 1.1, 2.0, 2.1, 2.2, 3.0, 3.1
Synonyms Tried: Essential Documents, Regulatory Documents, Trial Documents, Study Documents
Pages Checked: 1, 2, 3
Base Score: 100
| Severity | Count | Points Each | Total Deduction |
|---|---|---|---|
| HIGH | 7 | 10 | -70 |
| MEDIUM | 5 | 5 | -25 |
| LOW | 0 | 2 | -0 |
| Final Score | 5 |
Formula Version: 1.0.0
This analysis follows the FDA's January 2025 guidance "Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products."
Pre-submission protocol compliance review to identify regulatory gaps before filing.
Final compliance determination remains with protocol sponsor and regulatory authorities. ClinShield is an advisory tool designed to support, not replace, expert judgment.