Sample Protocol Template - NHLBI, NIH
Table of Contents
A Introduction 3
A1 Study Abstract 3
A2 Primary Hypothesis 3
A3 Purpose of the Study Protocol 3
B Background 3
B1 Prior Literature and Studies 3
B2 Rationale for this Study 3
C Study Objectives 3
C1 Primary Aim 3
C2 Secondary Aim 3
C3 Rationale for the Selection of Outcome Measures 3
D Investigational Agent 3
D1 Preclinical Data 3
D2 Clinical Data to Date 4
D3 Dose Rationale and Risk/Benefits 4
E Study Design 4
E1 Overview or Design Summary 4
E2 Subject Selection and Withdrawal 4
2.a Inclusion Criteria 4
2.a Exclusion Criteria 4
2.b Ethical Considerations 4
2.c Subject Recruitment Plans and Consent Process 4
2.d Randomization Method and Blinding 4
2.e Risks and Benefits 4
2.f Early Withdrawal of Subjects 4
2.g When and How to Withdraw Subjects 4
2.h Data Collection and Follow-up for Withdrawn Subjects 4
E3 Study Drug 5
3.a Description 5
3.b Treatment Regimen 5
3.c Method for Assigning Subjects to Treatment Groups 5
3.d Preparation and Administration of Study Drug 5
3.e Subject Compliance Monitoring 5
3.f Prior and Concomitant Therapy 5
3.g Packaging 5
3.h Blinding of Study Drug 5
3.i Receiving, Storage, Dispensing and Return 5
F Study Procedures 5
F1 Screening for Eligibility 5
F2 Schedule of Measurements 5
F3 Visit 1 5
F4 Visit 2 etc. 6
F5 Safety and Adverse Events 6
5.a Safety and Compliance Monitoring 6
5.b Medical Monitoring 6
i Investigator only 6
ii Independent expert to monitor 6
iii Institutional Data and Safety Monitoring Board 6
iv Independent Data and Safety Monitoring Board 6
5.c Definitions of Adverse Events 6
5.d Classification of Events 6
i Relationship 6
ii Severity 6
iii Expectedness 6
5.e Data Collection Procedures for Adverse Events 6
5.f Reporting Procedures 6
5.g Adverse Event Reporting Period 7
5.h Post-study Adverse Event 7
F6 Study Outcome Measurements and Ascertainment 7
G Statistical Plan 7
G1 Sample Size Determination and Power 7
G2 Interim Monitoring and Early Stopping 7
G3 Analysis Plan 7
G4 Statistical Methods 7
G5 Missing Outcome Data 7
G6 Unblinding Procedures 7
H Data Handling and Record Keeping 7
H1 Confidentiality and Security 7
H2 Training 7
H3 Case Report Forms and Source Documents 7
H4 Records Retention 8
H5 Performance Monitoring 8
I Study Monitoring, Auditing, and Inspecting 8
I1 Study Monitoring Plan 8
I2 Auditing and Inspecting 8
J Study Administration 8
J1 Organization and Participating Centers 8
J2 Funding Source and Conflicts of Interest 8
J3 Committees 8
J4 Subject Stipends or Payments 8
J5 Study Timetable 8
K Publication Plan 8
L Attachments 9
L1 Tables 9
L2 Informed consent documents 9
L3 Patient education brochures 9
L4 Special procedures protocols 9
L5 Questionnaires or surveys 9
M References 9
Introduction
1 Study Abstract
2 Primary Hypothesis
3 Purpose of the Study Protocol
Background
1 Prior Literature and Studies
2 Rationale for this Study
Study Objectives
1 Primary Aim
2 Secondary Aim
3 Rationale for the Selection of Outcome Measures
Investigational Agent
1 Preclinical Data
2 Clinical Data to Date
3 Dose Rationale and Risk/Benefits
Study Design
1 Overview or Design Summary
2 Subject Selection and Withdrawal
1 Inclusion Criteria
2 Exclusion Criteria
3 Ethical Considerations
4 Subject Recruitment Plans and Consent Process
5 Randomization Method and Blinding
6 Risks and Benefits
7 Early Withdrawal of Subjects
8 When and How to Withdraw Subjects
9 Data Collection and Follow-up for Withdrawn Subjects
3 Study Drug
1 Description
2 Treatment Regimen
3 Method for Assigning Subjects to Treatment Groups
4 Preparation and Administration of Study Drug
5 Subject Compliance Monitoring
6 Prior and Concomitant Therapy
7 Packaging
8 Blinding of Study Drug
9 Receiving, Storage, Dispensing and Return
Study Procedures
1 Screening for Eligibility
2 Schedule of Measurements
3 Visit 1
4 Visit 2 etc.
5 Safety and Adverse Events
1 Safety and Compliance Monitoring
2 Medical Monitoring
1 Investigator only
2 Independent expert to monitor
3 Institutional Data and Safety Monitoring Board
4 Independent Data and Safety Monitoring Board
3 Definitions of Adverse Events
4 Classification of Events
1 Relationship
2 Severity
3 Expectedness
5 Data Collection Procedures for Adverse Events
6 Reporting Procedures
7 Adverse Event Reporting Period
8 Post-study Adverse Event
6 Study Outcome Measurements and Ascertainment
Statistical Plan
1 Sample Size Determination and Power
2 Interim Monitoring and Early Stopping
3 Analysis Plan
4 Statistical Methods
5 Missing Outcome Data
6 Unblinding Procedures
Data Handling and Record Keeping
1 Confidentiality and Security
2 Training
3 Case Report Forms and Source Documents
4 Records Retention
5 Performance Monitoring
Study Monitoring, Auditing, and Inspecting
1 Study Monitoring Plan
2 Auditing and Inspecting
Study Administration
1 Organization and Participating Centers
2 Funding Source and Conflicts of Interest
3 Committees
4 Subject Stipends or Payments
5 Study Timetable
Publication Plan
Attachments
1 Tables
2 Informed consent documents
3 Patient education brochures
4 Special procedures protocols
5 Questionnaires or surveys
References
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