Prospective Research Study Protocol Template - Can a Prescribed Walking Program with or without Monitoring Impact Dizziness in the Older Adults?

Sep 5, 2026

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Prospective research study protocol template for evaluating whether a prescribed walking program, with or without monitoring, affects dizziness among older adults. The protocol identifies study sponsorship and principal investigator information and organizes key methodological elements, including objectives, study and research design, intervention description, recruitment and screening, consent procedures, randomization, and study visit schedules. It also specifies outcome measures, data management and quality plans, confidentiality and de-identification, sample size determination, statistical analysis, and a comprehensive risk/benefit and mitigation framework.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages29

Reading Time1 h 13 min

AccessFree to download

List of Abbreviations

Introduction

Background Information and Scientific Rationale

Study Objectives

Study Design

Research Design

Study Agent, Device, and/or Intervention Description

Study Site(s)/Location(s) and Number of Subjects

Multi-Site Research Logistics/Communication Plan

Research Conducted in a Foreign Country

Community-Based Participatory Research

Subject Selection

Vulnerable Populations (if applicable)

Inclusion Criteria

Exclusion Criteria

Resources Available

Study Procedures

Subject Recruitment and Screening

Consent Process

Documentation of Informed Consent Process

Randomization

Study Visits

Study Duration

Materials of Human Origin: Collection, Preparation, Handling and Shipping

Study Outcome Measures (Endpoints)

Data Management and Quality Plan

Data De-identification

Data Confidentiality, Storage, and Retention

Data Quality

Data Sharing (outside of Florida Hospital)

Sample Size Determination

Statistical Analysis Plan

Potential Risks and Benefits

Potential Benefits

Potential Risks

Mitigation of Risks

Provisions to Protect the Privacy Interest of Subjects

Early Withdrawal of Subjects

Investigator Withdrawal of Subjects

Subject Request for Withdrawal from Study

Prospective Research Study Protocol Template Study Protocol Title: “Can A Prescribed Walking Program with or without Monitoring Impact Dizziness in the Older Adults?” Study Sponsor: Florida Hospital Principal Investigator: Amie Marie Jasper Current Version Date: Previous Version Date: 11/30/2018 12/28/2018 IRBNet \#: 1038487 Page 1 of 26 Research Study protocol template version date 11/3/2016 List of Abbreviations: ..................................................................................................................... 4 Introduction ..................................................................................................................................... 5 Background Information and Scientific Rationale ......................................................................... 5 Study Objectives ............................................................................................................................. 8 Study Design ................................................................................................................................... 8 Research Design.......................................................................................................................... 8 Study Agent, Device, and/or Intervention Description ............................................................... 9 Study Site(s)/Location(s) and Number of Subjects .................................................................... 9 Multi-Site Research Logistics/Communication Plan .................................................................. 9 Research Conducted in a Foreign Country ............................................................................... 10 Community-Based Participatory Research ............................................................................... 10 Subject Selection ........................................................................................................................... 10 Vulnerable Populations (if applicable) ..................................................................................... 10 Inclusion Criteria ...................................................................................................................... 10 Exclusion Criteria ..................................................................................................................... 10 Resources Available ...................................................................................................................... 10 Study Procedures .......................................................................................................................... 12 Subject Recruitment and Screening .......................................................................................... 12 Consent Process ........................................................................................................................ 12 Documentation of Informed Consent Process .......................................................................... 12 Randomization .......................................................................................................................... 12 Study Visits ............................................................................................................................... 14 Study Duration .......................................................................................................................... 16 Materials of Human Origin: Collection, Preparation, Handling and Shipping........................ 17 Study Outcome Measures (Endpoints) ......................................................................................... 17 Data Management and Quality Plan ............................................................................................. 18 Data De-identification ..............................................

FAQs

What is the primary research question of this study protocol?

Whether a prescribed walking program, with or without monitoring, impacts dizziness in older adults.

How does the protocol address participant recruitment and consent?

It includes subject recruitment and screening steps, a consent process, and documentation of the informed consent procedures.

What major elements cover study execution and data handling?

The protocol specifies research design, intervention details, randomization, study visits and duration, outcome measures, and data management including de-identification, confidentiality, storage/retention, and data quality.

Sep 5, 2026

Upload by Gloria