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Protocol Development

Developing a Protocol

IRB accreditation logo.jpgThe 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

References

Literature searches
Appendix materialsData collection forms
Proposed tables and figures
Other relevant documents