University of California, Davis
IND 00000
8/27/2014
Study Title
Study Protocol Template
STUDY PROTOCOL
STUDY TTITLE
PROTOCOL NUMBER
STUDY PHASE
STUDY DRUG
IND Number
Indication
PRINCIPAL INVESIGATOR
CO-PRINCIPAL INVESTIGATORS
Dr X, MD
Department of X
UC Davis School of Medicine
Address
Sacramento CA 95816
Phone: | Fax:
Dr Y, MD
Address
Phone
Dr.Z, MD
Address
Faranak Kamangar, MD
Address
Phone
Phone
MEDICAL MONITOR
[If applicable]
SPONSOR
Dr. X, MD
SPONSOR CONTACT
Address
Phone
DATE
September 2, 2014
University of California, Davis
IND 00000
8/27/2014
Study Title
SIGNATURE PAGE
Sponsor Approval:
Signature: _________________________________
Date:______________________
Name (print): Dr. X, MD
Investigator Agreement:
Signature: __________________________________ Date:__________________
Name (print): Dr. Y, MD
Institution (print): University of California, Davis
University of California, Davis
IND 00000
8/27/2014
Study Title
SYNOPSIS
Name of Sponsor:
Protocol Number:
Phase of Development:
Title of the Protocol:
Primary Objectives:
Secondary Objectives:
Study Design and Methodology:
Study Population and Main Criteria for inclusion/Exclusion:
Randomization:
Number of Subjects:
Test Product, Dose and Mode of Administration:
Duration of treatment:
Reference Therapy, Dose and Mode of Administration
Criteria for Evaluation (Primary Efficacy and Secondary Efficacy):
Safety:
Safety Monitoring:
Efficacy Data:
Pharmacokinetics Data:
Statistical Methods:
Schedule of Events
University of California, Davis
IND 00000
8/27/2014
Study Title
List of Acronyms, Abbreviations, Definitions of Terms
University of California, Davis
IND 00000
8/27/2014
Study Title
PROTOCOL NARRATIVE
1.
2.
3.
4.
ETHICS
INVESTIGATOR AND STUDY ADMINISTRATIVE STRUCTURE
OVERVIEW (RATIONALE FOR THE STUDY)
STUDY OBJECTIVES
4.1
Primary
4.2
Secondary
4.3
Exploratory
5. INVESTIGATIONAL PLAN
5.1
Overall Study Design and Plan
5.2
Discussion of study design, including the choice of control group
5.3
Selection of study population
5.3.1 Number of Subjects
5.3.2 Inclusion Criteria
5.3.3 Exclusion Criteria
5.3.4 Removal of Subjects from Therapy or Assessments
5.4
Treatments
5.4.1 Treatments Administered
5.4.2 Identity of Investigational Product
5.4.3 Method for Assigning Subjects to Treatment Groups
5.4.4 Subject Numbering
5.4.5 Blinding
5.4.6 Selection of Doses in the Study (safety, PK, therapeutic effects)
5.4.7 Selection and timing of dose for each subjects
5.4.8 Missed Doses
5.4.9 Excluded, prior and Concomitant medications
5.4.10 Treatment Compliance
5.5
Efficacy and Safety Assessment
University of California, Davis
IND 00000
8/27/2014
Study Title
5.5.1 Efficacy Assessments
5.5.2 Safety Assessments
5.5.3 Study Activities and Procedures by Study Visit
5.5.4. Study Extension
5.5.5 Appropriateness of Measurements
5.5.6 Primary Efficacy Variables
5.6
Study Drug Concentration measurements [if applicable]
5.7
Data Quality Assurance
5.8
Statistical Methods and Analytical Plans and Determination of Sample Size
5.8.1 Randomization
5.8.2 Analysis Population
5.8.3 Missing Data Group [if applicable]
5.8.4 Baseline and Demographic characteristics
5.8.5 Analysis of Primary Efficacy Variable
5.8.6 Secondary Analyses and Analysis of Secondary Efficacy Variable
5.8.7 Analysis of Safety Variables
5.8.8 Determination of Sample Size
5.8.9 Interim Analysis Methods [if applicable]
6. INVESTIGATOR REQUIREMENTS
6.1
Study Initiation
6.2
Study Completion
6.3
Study Discontinuation
6.4
Informed Consent
6.5
Adverse Events
6.5.1 Definitions
6.5.2 Evaluating and Recording Adverse Events
University of California, Davis
IND 00000
8/27/2014
Study Title
6.5.3 Reporting Adverse Events
6.6
Study Monitoring
6.7
Electronic Case Report Forms
6.8
Study Drug Accountability
6.9
Confidentiality of Data
6.10
Retention of Records
6.11
Protocol Adherence
7. REFERENCES
8. APPENDICES