Protocol Design Assistant

Study Overview

Let's start with the basics of your study

Study Title *

Short Summary *

Research Objectives

What are you trying to learn or accomplish?

Research Objective(s) *

Hypothesis (Optional)

Study Design

Define your research approach

Study Type *

Observational (collecting data without intervention)

Interventional (testing an intervention or treatment)

Temporal Design *

Prospective (collecting data going forward)

Retrospective (analyzing existing data)

Population & Sample

Who will participate in your study?

Inclusion Criteria *

Exclusion Criteria (Optional)

Expected Sample Size *

Procedures & Data Collection

What will participants do?

Procedures & Activities *

Data Collection Method *

Data will include identifiable information (names, contact info, etc.)

Risks & Mitigations

How will you protect participants?

Risk Level *

Minimal risk (no greater than everyday life)

Greater than minimal risk

Risk Description *

Risk Mitigations *

Safety Monitoring (Optional)

Consent Process

How will you obtain informed consent?

Consent Type *

Written consent

Verbal consent

Consent waiver (requesting exemption)

Consent/Assent Plan *

Data Handling

How will you manage and protect data?

Confidentiality Measures *

Data Storage *

Data Retention *

Data Access *

Build Your Protocol Draft