Capture.Study
Observational Study
FDA Compliant

Observational Study

Simplified consent for non-interventional research focused on data collection and privacy. Ideal for surveys and registry studies.

Consent Form Sections

This template includes 8 sections covering all required elements

1

Introduction

You are being invited to participate in a research study. This study involves observation and data collection only - there are no experimental treatments or procedures.

Please read this form carefully. Feel free to ask questions before deciding whether to participate.

2

Purpose of the Study

The purpose of this study is to [STUDY_PURPOSE].

We hope to learn [EXPECTED_OUTCOMES]. This information may help [POTENTIAL_BENEFITS_TO_SCIENCE].

3

What Will Happen

If you agree to participate, you will be asked to:

  • Complete questionnaires about [TOPICS]
  • [OTHER_ACTIVITIES]

This will take approximately [TIME_COMMITMENT]. You can complete the questionnaires [LOCATION/METHOD].

4

Risks

This study involves minimal risk. Possible risks include:

  • Discomfort when answering personal questions
  • Time required to complete questionnaires
  • [OTHER_MINIMAL_RISKS]

You may skip any questions you do not wish to answer.

5

Benefits

There are no direct benefits to you for participating. Your participation will contribute to research that may benefit others in the future.

6

Privacy and Data Protection

Your responses will be kept confidential. Your data will be:

  • Stored securely with encryption
  • Identified only by a coded participant number
  • Accessible only to authorized research staff
  • Never sold or shared for commercial purposes

Your name will not appear in any reports or publications from this study.

7

Voluntary Participation

Your participation is voluntary. You may:

  • Choose not to participate
  • Skip questions you do not want to answer
  • Withdraw at any time without penalty

Withdrawing will not affect any services you receive.

8

Contact Information

For questions about this study: [RESEARCHER_NAME] [RESEARCHER_CONTACT]

For questions about your rights as a participant: [IRB_CONTACT]

Regulatory Compliance

  • Includes all FDA-required elements per 21 CFR 50.25
  • Complies with ICH-GCP E6(R2) guidelines
  • Written at appropriate reading level (8th grade or below)
  • Customizable for your study-specific requirements

Use This Template

Get started with compliant eConsent

✓ Fully customizable template

✓ Electronic signature capture

✓ Audit trail & version control

✓ 21 CFR Part 11 compliant

Template Details

Sections8
CategoryObservational Study
Compliance
FDA

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