Get the free Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials - fda

This guidance recommends a standardized approach for collecting and reporting race and ethnicity information in clinical trials for FDA regulated products, emphasizing the importance of uniform methodologies

How to fill out guidance for industry

How to fill out Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials

1. Review the Guidance for Industry document to understand the purpose and requirements.
2. Identify the clinical trial's objectives related to race and ethnicity data collection.
3. Determine the appropriate demographic categories to be used in the trial based on the guidance.
4. Develop a strategy for collecting data, ensuring compliance with applicable laws and regulations.
5. Train staff and investigators on how to collect the data accurately and respectfully.
6. Implement the data collection process during the clinical trial, ensuring confidentiality and data integrity.
7. Analyze the collected data to assess representation and disparities in trial participation.
8. Report the findings in accordance with the guidance and relevant regulatory requirements.

Who needs Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials?

1. Clinical trial sponsors and researchers conducting trials that involve diverse populations.
2. Regulatory agencies that oversee clinical trial compliance and data reporting.
3. Health organizations and advocacy groups focused on health equity and representation.
4. Pharmaceutical and biotechnology companies developing treatments for diverse patient populations.

People Also Ask about

How to categorize race and ethnicity?

The minimum categories for data on race and ethnicity for Federal statistics, program administrative reporting, and civil rights compliance reporting are defined as follows: -- American Indian or Alaska Native. -- Asian. -- Black or African American. -- Hispanic or Latino. -- Native Hawaiian or Other Pacific Islander.

How do you list race and ethnicity on a survey?

We recommend using the following race/ethnicity question instead: American Indian, Alaska Native or Indigenous. "East Asian" "South Asian" "Southeast Asian" Black or African American. Hispanic or "Latino, Latina or Latine" Native Hawaiian or Other Pacific Islander. White.

What is considered a challenge of the collection of race and ethnicity data?

Race and ethnicity do not have standard scientific definitions making these variables difficult to measure. Without a standard scientific definition, many question whether meaningful comparative research can be done when there is so much opportunity for misclassification.

What do I put for race vs ethnicity?

Race is a social construct based on the color of the skin. Ethnicity is about your cultural inheritance including language, heritage, customs and geographic location.

How do I word an ethnicity question on a survey?

First ask, “Are you of Hispanic, Latino, or of Spanish origin?” (ethnicity), followed by a race identification question like, “How would you describe yourself?” The first question can be a simple Yes/No radio button; the second should include these commonly accepted options: American Indian or Alaska Native. Asian.

What is the FDA guidance for diversity in clinical trials?

In April 2022, the U.S. Food and Drug Administration (FDA) published a draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”1 The purpose of this guidance was to help improve the strength and generalizability of the evidence

What do you put for race and ethnicity on forms?

You can put whatever you want, bit I'd guess the large majority pick either ``White'' or ``American Indian or Alaska Native'' or both of those or ``some other race''.

For pdfFiller’s FAQs

What is Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials?

It is a document issued by regulatory agencies that provides recommendations for collecting and reporting race and ethnicity data in clinical trials to ensure that diverse populations are adequately represented and to improve the understanding of the effects of treatments across different demographic groups.

Who is required to file Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials?

Sponsors and investigators of clinical trials that seek approval from regulatory agencies such as the FDA are required to adhere to the guidelines provided in the document when collecting race and ethnicity data.

How to fill out Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials?

The guidance recommends using standardized categories for race and ethnicity, ensuring that all participants are asked to self-identify their race and ethnicity, and documenting this information in a consistent manner throughout the trial.

What is the purpose of Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials?

The purpose is to enhance the understanding of how different races and ethnicities respond to treatments, to support the development of more effective therapies, and to ensure that clinical research is inclusive and relevant to diverse populations.

What information must be reported on Guidance for Industry - Collection of Race and Ethnicity Data in Clinical Trials?

The guidance requires reporting the race and ethnicity of participants, including categories such as Asian, Black or African American, Hispanic or Latino, Native American, and White, as well as other relevant demographic information that may impact treatment outcomes.