Get the free Study #916 Protocol

This document outlines the protocol for a clinical investigation to evaluate the product performance of the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens. The study involves approximately 300 subjects at up to 20 investigative sites in the United States following good clinical practices standards. The objective is to assess lens performance in current soft contact lens wearers who require multifocal correction.

How to fill out study 916 protocol

How to fill out study 916 protocol

1. Begin by reviewing the objectives of the study to ensure proper understanding.
2. Gather all necessary materials and documentation required for the protocol.
3. Fill out the title section with the full name of the study.
4. Complete the background section, providing context and rationale for the study.
5. Specify the study design and methodology in detail.
6. List out the inclusion and exclusion criteria for participant selection.
7. Outline the procedures for data collection and analysis.
8. Assign roles and responsibilities to all personnel involved in the study.
9. Review budget and resources needed for implementation.
10. Ensure compliance with ethical standards by including plans for informed consent and data protection.
11. Double-check all entries for accuracy and completeness before submission.

Who needs study 916 protocol?

1. Researchers conducting clinical trials.
2. Institutional review boards overseeing study compliance.
3. Medical professionals involved in the trial.
4. Funding agencies assessing research proposals.
5. Participants who need to understand study requirements.

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What is study 916 protocol?

The study 916 protocol is a regulatory framework used for research and clinical trials to ensure compliance with ethical standards and data integrity.

Who is required to file study 916 protocol?

Researchers, institutions, and sponsors involved in clinical trials or related studies that require regulatory approval must file the study 916 protocol.

How to fill out study 916 protocol?

The study 916 protocol can be filled out by following the specific guidelines provided by the regulatory authority, which typically include sections on study objectives, methodology, and safety assessments.

What is the purpose of study 916 protocol?

The purpose of the study 916 protocol is to outline the objectives, methods, and ethical considerations of a research study, ensuring that it is conducted safely and effectively.

What information must be reported on study 916 protocol?

Key information to be reported includes study objectives, design, participant criteria, data collection methods, safety monitoring, and consent procedures.