Sample Protocol Template by JohnKirkpatrick

VIEWS: 82 PAGES: 9

									NHLBI Sample Protocol Template                                                                                                            September, 2006

______________________________________________________________________________________




                                                         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 ...............................................................................................................3
    D3          DOSE RATIONALE AND R ISK/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 ..................................................................................................................................4
      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 E LIGIBILITY ..........................................................................................................5
    F2          SCHEDULE OF MEASUREMENTS ......................................................................................................5
    F3          VISIT 1 ............................................................................................................................................5



                                                                                1
NHLBI Sample Protocol Template                                                                                                                                  September, 2006

______________________________________________________________________________________
    F4       VISIT 2 ETC. ....................................................................................................................................5
    F5       SAFETY AND ADVERSE EVENTS ......................................................................................................5
         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................................................................................................6
         5.h         Post-study Adverse Event ..........................................................................................................6
    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 M ETHODS ..................................................................................................................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 .....................................................................................................................7
    H5             PERFORMANCE MONITORING ..........................................................................................................7
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 .................................................................................................................................8
    L1             TABLES ...........................................................................................................................................8
    L2             INFORMED CONSENT DOCUMENTS ...................................................................................................8
    L3             PATIENT EDUCATION BROCHURES ...................................................................................................9
    L4             SPECIAL PROCEDURES PROTOCOLS .................................................................................................9
    L5             QUESTIONNAIRES OR SURVEYS .......................................................................................................9
M        REFERENCES .....................................................................................................................................9




                                                                                             2
NHLBI Sample Protocol Template                                          September, 2006

______________________________________________________________________________________

A Introduction

A1 Study Abstract


A2 Primary Hypothesis


A3 Purpose of the Study Protocol


B Background

B1 Prior Literature and Studies


B2 Rationale for this Study


C Study Objectives

C1 Primary Aim


C2 Secondary Aim


C3 Rationale for the Selection of Outcome Measures


D Investigational Agent

D1 Preclinical Data


D2 Clinical Data to Date




                                          3
NHLBI Sample Protocol Template                                          September, 2006

______________________________________________________________________________________

D3 Dose Rationale and Risk/Benefits


E Study Design

E1 Overview or Design Summary


E2 Subject Selection and Withdrawal


2.a    Inclusion Criteria


2.a    Exclusion Criteria


2.b    Ethical Considerations


2.c    Subject Recruitment Plans and Consent Process


2.d    Randomization Method and Blinding


2.e    Risks and Benefits


2.f    Early Withdrawal of Subjects


2.g    When and How to Withdraw Subjects


2.h    Data Collection and Follow-up for Withdrawn Subjects



E3 Study Drug




                                          4
NHLBI Sample Protocol Template                                          September, 2006

______________________________________________________________________________________

3.a    Description


3.b    Treatment Regimen


3.c    Method for Assigning Subjects to Treatment Groups


3.d    Preparation and Administration of Study Drug


3.e    Subject Compliance Monitoring


3.f    Prior and Concomitant Therapy


3.g    Packaging


3.h    Blinding of Study Drug


3.i    Receiving, Storage, Dispensing and Return


F Study Procedures

F1 Screening for Eligibility


F2 Schedule of Measurements


F3 Visit 1


F4 Visit 2 etc.


F5 Safety and Adverse Events



                                          5
NHLBI Sample Protocol Template                                          September, 2006

______________________________________________________________________________________

5.a    Safety and Compliance Monitoring


5.b    Medical Monitoring


i        Investigator only


ii       Independent expert to monitor


iii      Institutional Data and Safety Monitoring Board


iv       Independent Data and Safety Monitoring Board


5.c    Definitions of Adverse Events


5.d    Classification of Events


i        Relationship


ii       Severity


iii      Expectedness


5.e    Data Collection Procedures for Adverse Events


5.f    Reporting Procedures


5.g    Adverse Event Reporting Period


5.h    Post-study Adverse Event




                                          6
NHLBI Sample Protocol Template                                          September, 2006

______________________________________________________________________________________

F6 Study Outcome Measurements and Ascertainment


G Statistical Plan

G1     Sample Size Determination and Power


G2     Interim Monitoring and Early Stopping


G3     Analysis Plan


G4     Statistical Methods


G5     Missing Outcome Data


G6     Unblinding Procedures



H Data Handling and Record Keeping

H1 Confidentiality and Security


H2 Training


H3 Case Report Forms and Source Documents


H4 Records Retention


H5 Performance Monitoring




                                          7
NHLBI Sample Protocol Template                                          September, 2006

______________________________________________________________________________________

I    Study Monitoring, Auditing, and Inspecting

I1    Study Monitoring Plan


I2    Auditing and Inspecting


J Study Administration

J1 Organization and Participating Centers


J2 Funding Source and Conflicts of Interest


J3 Committees


J4 Subject Stipends or Payments


J5     Study Timetable



K Publication Plan




L    Attachments

L1     Tables


L2     Informed consent documents



                                          8
NHLBI Sample Protocol Template                                          September, 2006

______________________________________________________________________________________

L3     Patient education brochures


L4     Special procedures protocols


L5     Questionnaires or surveys



M References




                                          9

								
To top