Policies and Guidance


IRB Meeting Dates and DeadlinesIs It Human Subject Research?Templates and Samples
  • Developing a Protocol

    The quality of science is often improved when study objectives and methods are clearly thought through and described. A written protocol facilitates high quality science and is an invaluable tool to investigators as they develop and conduct studies.

    Regardless of the scientific discipline in which the study is undertaken, the same scientific method is used. Further, while the scientific content will differ across studies, the general elements of the study protocol will be similar.

    The Excellence in Science committee at the Centers for Disease Control and Prevention (CDC) has developed a general protocol checklist and companion guide to assist scientists in preparing protocols The checklist is intended as an aid in suggesting a format for writing protocols and in identifying issues that scientists should consider as they design the study. The checklist was developed to have utility in conducting laboratory and basic science studies, epidemiologic studies, and behavioral and social science studies employing a variety of study designs.

    In using the checklist, investigators should select the items that apply to their types of studies.It is unlikely that any protocol would include every item on the checklist.

    General protocol checklist

    This checklist is intended as an aid in suggesting a format for writing protocols and in identifying issues that scientists should consider as they design a study or surveillance system. When using the checklist, investigators should select the items that apply to their specific project. It is not expected that every item on the checklist is applicable to each protocol for a study or surveillance system.

     

    SectionItem 
    Project overviewTitle  
    Protocol summary 
    Investigators & roles/collaborators & roles/funding sources 
    Introduction
     
     
     
    Literature review/current state of knowledge about project topics 
    Justification for study 
    Intended/potential use of study findings 
    Study design/locations 
    Objectives 
    Hypotheses or questions 
    Procedure/methods designHow study design or surveillance system address hypothese and meets objectives 
    Audience and stakeholder participation 
    Study timeline 
    Procedures/methods
    study population

     
     
     
     
     
    Description and source of study population 
    Case definitions 
    Participant inclusion criteria 
    Participant exclusion criteria 
    Justification of exclusion of any sub-segment of the population 
    Estimated number of participants 
    Enrollment 
    Consent Process - WILL SEEK WAIVER 
    Procedures/methods
    Variables/interventions
    Variables 
    Study instruments, including questionnaires, laboratory instruments and analytic tests (including abstract form, paper and electronic) 
    Training for all study personnel 
    Data collection
     
     
     
    Information management and analysis software (abstracting software) 
    Data entry, editing and management, including handling data collection forms, different versions of data and data storage and disposition (including treatment data consolidation) 
    Quality control/assurance 
    Bias in data collection, measurement and analysis 
    Intermediate reviews and analyses (pilot test) 
    Limitations of study 
    Procedure/methods
    disseminations, notification and reporting of results
    Notifying participants of study findings 
    Anticipated products or inventions resulting from the study and their uses 
    Disseminating results to public (including data publication guidelines and manuscript writing roles 
    ReferencesLiterature searches 
    Appendix materialsData collection forms 
    Proposed tables and figures 
    Other relevant documents