TITLE
NIDCR Protocol Number:
NIDCR Funding Mechanism:
Pharmaceutical/Other Support Provided by
Other Identifying Numbers:
IND Sponsor:
Principal Investigator:
NIDCR Program Official:
NIDCR Medical Monitor:
Draft or Version Number:
Day Month Year
STATEMENT OF COMPLIANCE
SIGNATURE PAGE
The signature below constitutes the approval of this protocol and the attachments, and provides the necessary assurances that this trial/study will be conducted according to all stipulations of the protocol, including all statements regarding confidentiality, and according to local legal and regulatory requirements and applicable US federal regulations and ICH guidelines.
Site Investigator:
Signed: __________________________________________ Date: _________________
Name
Title
TABLE OF CONTENTS
Statement of Compliance
Signature Page
Table of Contents
List of Abbreviations
Protocol Summary
1 Key Roles
2 Introduction: Background Information and Scientific Rationale
2.1 Background Information
2.2 Rationale
2.3 Potential Risks and Benefits
2.3.1 Potential Risks
2.3.2 Known Potential Benefits
3 Objectives
3.1 Study Objectives
3.2 Study Outcome Measures
3.2.1 Primary Outcome Measures
3.2.2 Secondary Outcome Measures
4 Study Design
4.1 Substudies (if applicable)
5 Study Enrollment and Withdrawal
5.1 Subject Inclusion Criteria
5.2 Subject Exclusion Criteria
5.3 Strategies for Recruitment and Retention
5.4 Treatment Assignment Procedures
5.4.1 Randomization Procedures
5.4.2 Masking Procedures
5.4.3 Reasons for Withdrawal
5.4.4 Handling of Withdrawals
5.4.5 Termination of Study
6 Study Intervention/Investigational Product
6.1 Study Product Description
6.1.1 Acquisition
6.1.2 Formulation, Packaging, and Labeling
6.1.3 Product Storage and Stability
6.2 Dosage, Preparation and Administration of Study Intervention/Investigational Product
6.3 Modification of Study Intervention/Investigational Product for a Subject
6.4 Accountability Procedures for the Study Intervention/Investigational Product(s)
6.5 Assessment of Subject Compliance with Study Intervention/Investigational Product
6.6 Concomitant Medications/Treatments
7 Study Schedule
7.1 Screening
7.2 Enrollment/Baseline
7.3 Follow-up
7.4 Final Study Visit
7.5 Early Termination Visit
7.6 Unscheduled Visit
8 Study Procedures/Evaluations
8.1 Clinical Evaluations
8.2 Laboratory Evaluations
8.2.1 Clinical Laboratory Evaluations
8.2.2 Special Assays or Procedures
8.2.3 Specimen Preparation, Handling, and Shipping
9 Assessment of Safety
9.1 Specification of Safety Parameters
9.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters
9.2.1 Adverse Events
9.2.2 Expected Adverse Reactions
9.2.3 Serious Adverse Events
9.2.4 Unanticipated Problems
9.2.5 Procedures to be Followed in the Event of Abnormal Laboratory Test Values or Abnormal Clinical Findings
9.3 Reporting Procedures
9.3.1 Serious Adverse Events
9.3.2 Regulatory Reporting for Studies Conducted Under NIDCR-Sponsored IND
9.3.3 Regulatory Reporting for Studies Not Conducted Under NIDCR-Sponsored IND
9.3.4 Other Adverse Events (if applicable)
9.3.5 Other Unanticipated Problems
9.3.6 Reporting of Pregnancy
9.4 Type and Duration of Follow-up of Subjects after Adverse Events
9.5 Halting Rules
9.6 Safety Oversight (ISM plus SMC or DSMB)
10 Clinical Monitoring
10.1 Site Monitoring Plan
11 Statistical Considerations
11.1 Study Hypotheses
11.2 Sample Size Considerations
11.3 Planned Interim Analyses (if applicable)
11.3.1 Safety Review
11.3.2 Efficacy Review
11.4 Final Analysis Plan
12 Source Documents and Access to Source Data/Documents
13 Quality Control and Quality Assurance
14 Ethics/Protection of Human Subjects
14.1 Ethical Standard
14.2 Institutional Review Board
14.3 Informed Consent Process
14.3.1 Informed Consent/Assent Process (in Case of a Minor)
14.4 Exclusion of Women, Minorities, and Children (Special Populations)
14.5 Subject Confidentiality
14.6 Study Discontinuation
14.7 Future Use of Stored Specimens
15 Data Handling and Record Keeping
15.1 Data Management Responsibilities
15.2 Data Capture Methods
15.3 Types of Data
15.4 Timing/Reports
15.5 Study Records Retention
15.6 Protocol Deviations
16 Publication Policy
17 Literature References
Supplements/Appendices
Appendix A: Schedule of Events
LIST OF ABBREVIATIONS
| AE |
Adverse Event/Adverse Experience |
| CFR |
Code of Federal Regulations |
| CIOMS |
Council for International Organizations of Medical Sciences |
| CONSORT |
Consolidated Standards of Reporting Trials |
| CFR |
Code of Federal Regulations |
| CIB |
Clinical Investigator’s Brochure |
| CRF |
Case Report Form |
| CRO |
Contract Research Organization |
| CSOC |
Clinical Study Oversight Committee |
| DCC |
Data Coordinating Center |
| DHHS |
Department of Health and Human Services |
| DMFS |
Decayed, missing, and filled tooth surfaces |
| DSMB |
Data and Safety Monitoring Board |
| eCRF |
Electronic Case Report Form |
| FDA |
Food and Drug Administration |
| FWA |
Federalwide Assurance |
| GCP |
Good Clinical Practice |
| HIPAA |
Health Insurance Portability and Accountability Act |
| ICF |
Informed Consent Form |
| ICH |
International Conference on Harmonisation |
| ICMJE |
International Committee of Medical Journal Editors |
| IDE |
Investigational Device Exemption |
| IND |
Investigational New Drug Application |
| IRB |
Institutional Review Board |
| ISM |
Independent Safety Monitor |
| JAMA |
Journal of the American Medical Association |
| JADA |
Journal of the American Dental Association |
| MedDRA® |
Medical Dictionary for Regulatory Activities |
| MOP |
Manual of Procedures |
| N |
Number (typically refers to subjects) |
| NDA |
New Drug Application |
| NEJM |
New England Journal of Medicine |
| NIDCR |
National Institute of Dental and Craniofacial Research, NIH, DHHS |
| NIH |
National Institutes of Health |
| OCTOM |
Office of Clinical Operations and Management, NIDCR, NIH, DHHS |
| OHRP |
Office for Human Research Protections |
| OHSR |
Office of Human Subjects Research |
| PHI |
Protected Health Information |
| PI |
Principal Investigator |
| QA |
Quality Assurance |
| QC |
Quality Control |
| SAE |
Serious Adverse Event/Serious Adverse Experience |
| SMC |
Safety Monitoring Committee |
| SOP |
Standard Operating Procedure |
| US |
United States |
| WHO |
World Health Organization |
Please modify list to include your protocol-specific terms.
PROTOCOL SUMMARY
Title:
Précis:
Objectives:
Primary:
Secondary:
Population:
Phase:
Number of Sites:
Study Duration:
Subject Participation Duration:
Description of Agent or Intervention:
Estimated Time to Complete Enrollment:
Schematic of Study Design:
1 KEY ROLES
Individuals:
Principal Investigator:
Medical Monitor or Behavioral Scientist: (if applicable)
Program Official:
Institutions:
Optional:
2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE
2.1 Background Information
2.2 Rationale
2.3 Potential Risks and Benefits
2.3.1 Potential Risks
2.3.2 Known Potential Benefits
3 OBJECTIVES
3.1 Study Objectives
3.2 Study Outcome Measures
3.2.1 Primary Outcome Measures
3.2.2 Secondary Outcome Measures
4 STUDY DESIGN
4.1 Substudies (if applicable)
5 STUDY ENROLLMENT AND WITHDRAWAL
5.1 Subject Inclusion Criteria
5.2 Subject Exclusion Criteria
5.3 Strategies for Recruitment and Retention
5.4 Treatment Assignment Procedures
5.4.1 Randomization Procedures
5.4.2 Masking Procedures
5.4.3 Reasons for Withdrawal
5.4.4 Handling of Withdrawals
5.4.5 Termination of Study
6 STUDY INTERVENTION/INVESTIGATIONAL PRODUCT
6.1 Study Product Description
6.1.1 Acquisition
6.1.2 Formulation, Packaging, and Labeling
6.1.3 Product Storage and Stability
6.2 Dosage, Preparation and Administration of Study Intervention/Investigational Product
6.3 Modification of Study Intervention/Investigational Product for a Subject
6.4 Accountability Procedures for the Study Intervention/Investigational Product(s)
6.5 Assessment of Subject Compliance with Study Intervention/Investigational Product
6.6 Concomitant Medications/Treatments
7 STUDY SCHEDULE
7.1 Screening
7.2 Enrollment/Baseline
7.3 Follow-up
7.4 Final Study Visit
7.5 Early Termination Visit
7.6 Unscheduled Visit
8 STUDY PROCEDURES/EVALUATIONS
8.1 Clinical Evaluations
8.2 Laboratory Evaluations
8.2.1 Clinical Laboratory Evaluations
8.2.2 Special Assays or Procedures
8.2.3 Specimen Preparation, Handling, and Shipping
8.2.3.1 Instructions for Specimen Preparation, Handling, and Storage
8.2.3.2 Specimen Shipment
9 ASSESSMENT OF SAFETY
9.1 Specification of Safety Parameters
9.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters
9.2.1 Adverse Events
9.2.2 Expected Adverse Reactions
9.2.3 Serious Adverse Events
9.2.4 Unanticipated Problems
9.2.5 Procedures to be Followed in the Event of Abnormal Laboratory Test Values or Abnormal Clinical Findings
9.3 Reporting Procedures
9.3.1 Serious Adverse Events
9.3.2 Regulatory Reporting for Studies Conducted Under NIDCR-Sponsored IND
9.3.3 Regulatory Reporting for Studies Not Conducted Under NIDCR-Sponsored IND
9.3.4 Other Adverse Events (if applicable)
9.3.5 Other Unanticipated Problems
9.3.6 Reporting of Pregnancy
9.4 Type and Duration of Follow-up of Subjects after Adverse Events
9.5 Halting Rules
9.6 Safety Oversight (ISM plus SMC or DSMB)
10 CLINICAL MONITORING
10.1 Site Monitoring Plan
11 STATISTICAL CONSIDERATIONS
11.1 Study Hypotheses
11.2 Sample Size Considerations
11.3 Planned Interim Analyses (if applicable)
11.3.1 Safety Review
11.3.2 Efficacy Review
11.4 Final Analysis Plan
12 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS
13 QUALITY CONTROL AND QUALITY ASSURANCE
14 ETHICS/PROTECTION OF HUMAN SUBJECTS
14.1 Ethical Standard
14.2 Institutional Review Board
14.3 Informed Consent Process
14.3.1 Informed Consent/Assent Process (in Case of a Minor)
14.4 Exclusion of Women, Minorities, and Children (Special Populations)
14.5 Subject Confidentiality
14.6 Study Discontinuation
14.7 Future Use of Stored Specimens
15 DATA HANDLING AND RECORD KEEPING
15.1 Data Management Responsibilities
15.2 Data Capture Methods
15.3 Types of Data
15.4 Timing/Reports
15.5 Study Records Retention
15.6 Protocol Deviations
16 PUBLICATION POLICY
17 LITERATURE REFERENCES
SUPPLEMENTS/APPENDICES
APPENDIX A: SCHEDULE OF EVENTS
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