Clinical Trial Protocol Outline
I.
II.
III.
IV.
V.
Background/justification/rationale
A.
Description of disease being studied and problem being
addressed
B.
Description of current therapy and any shortcomings
C.
Description of drug and its activity
D.
Description of any comparator drugs and justification for its use
as the control
E.
Summaries of studies conducted to date
Objectives
A.
Primary
B.
Secondary
Study Design
A.
Single center or multicenter
B.
Phase
C.
Number and definition of arms
D.
Blinding
E.
Randomization if multiple arms
F.
Indication and patient population
G.
Sample size
H.
Duration and number of sites
Study population
A.
Inclusion
B.
Exclusion
Schedule of visits/assessments
VI.
A.
Screening/eligibility determination
B.
Consent
C.
Enrollment/randomization
D.
Baseline evaluation
E.
Treatment schedule
F.
Follow-up schedule
Ethical and Regulatory Considerations
A.
Regulatory document collection
B.
IRB review
C.
Informed consent administration
VII.
Study Procedures
VIII.
Clinical assessment
IX.
A.
Special procedures (QOL, bronchoscopy, biopsy, PK, genetic
sampling, etc.)
B.
Laboratory testing
Study drug and comparator
A.
Drug shipment/receipt
B.
Drug packaging
C.
Drug storage
D.
Drug preparation
E.
Drug dispensing and accountability
F.
Drug administration
G.
Contraindications/concomitant medications
H.
Breaking the blind
I.
Drug destruction
J.
X.
Adverse Experiences (AEs)
A.
Documentation of AEs
B.
Coding of AEs
C.
Serious Adverse Events
D.
XI.
XII.
Medication compliance assessment
1.
Definition
2.
Reporting
Expected AEs/toxicities
Subject Completion and Early Withdrawal
A.
Procedures for completion
B.
Procedures for early withdrawals
C.
Reasons for withdrawals
Data Collection
A.
Method of data collection
B.
Procedures for data collection
C.
Data submission
XIII.
Study Monitoring/Audits
XIV.
Data Analysis
A.
Sample size determination
B.
Efficacy analyses
C.
Safety analyses
D.
Other analyses (if applicable)
E.
Interim analyses (if applicable)
F.
Data Safety Monitoring Board (if applicable)
XV.
Confidentiality
XVI.
Publication Policy
XVII. References
XVIII. Appendices
A.
Declaration of Helsinki
B.
Template informed consent form
C.
Toxicity criteria
D.
Health status measurement scale
E.
Laboratory sample preparation and shipment
F.
Standardized clinical procedure methodology
G.
Standardized questionnaire instructions
H.
Standardized measurement instructions