Real-World Data Retrieval for Clinical Research

Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Adoption Level	Federally required	Cost	Test Tool Availability
Implementation Specification	FHIR to CDISC Joint Mapping Implementation Guide	Balloted Draft	Pilot		No	Free	N/A
Implementation Specification	HL7® FHIR® Retrieval of Real-World Data for Clinical Research	Balloted Draft	Pilot		No	Free	No

FFAP icon = Federal FHIR Action Plan: Marks standards for coordinated federal adoption. See Appendix V: Federal FHIR Action Plan for more details.

Federal FHIR Action Plan Alignment
HL7® FHIR® Retrieval of Real-World Data for Clinical Research The HL7® FHIR® Retrieval of Real-World Data for Clinical Research IG aims to address this need by providing implementation guidance to collect and use real-world data and real-world evidence. This Implementation Guide specifies the retrieval of RWD from Certified Health IT via HL7 FHIR APIs – users should note this specification does not provide guidance on downstream use of RWD once the RWD is obtained from the Certified Health IT. Implementers should note that this specification uses the HL7® FHIR® International Patient Access (IPA) IG as a baseline. The HL7® FHIR® Retrieval of Real-World Data for Clinical Research IG leverages the IPA IG to access the RWD but provides additional specifications on data elements and HL7 FHIR resources specific to clinical research.

Federal FHIR Action Plan Alignment

HL7® FHIR® Retrieval of Real-World Data for Clinical Research

The HL7® FHIR® Retrieval of Real-World Data for Clinical Research IG aims to address this need by providing implementation guidance to collect and use real-world data and real-world evidence. This Implementation Guide specifies the retrieval of RWD from Certified Health IT via HL7 FHIR APIs – users should note this specification does not provide guidance on downstream use of RWD once the RWD is obtained from the Certified Health IT.
Implementers should note that this specification uses the HL7® FHIR® International Patient Access (IPA) IG as a baseline. The HL7® FHIR® Retrieval of Real-World Data for Clinical Research IG leverages the IPA IG to access the RWD but provides additional specifications on data elements and HL7 FHIR resources specific to clinical research.

Limitations, Dependencies, and Preconditions for Consideration	Applicable Security Patterns for Consideration
The FHIR to CDISC Joint Mapping Implementation Guide defines mappings between FHIR release 4.0 and the following CDISC standards: Study Data Tabulation Model Implementation Guide (SDTMIG) 3.2 Clinical Data Acquisition Standards Harmonization Implementation Guide (CDASH) 2.1 LAB 1.0.1 The HL7 Retrieval of Real-World Data for Clinical Research implementation guide is dependent on the International Patient Access (IPA) for a baseline dataset. Refer to FDA’s Data Standards for Drug and Biological Product Submissions Containing Real-World Data for guidance on the use of real-world data (RWD) to generate real-world evidence (RWE) in regulatory decision-making.	Feedback requested

Limitations, Dependencies, and Preconditions for Consideration

Applicable Security Patterns for Consideration

The FHIR to CDISC Joint Mapping Implementation Guide defines mappings between FHIR release 4.0 and the following CDISC standards:
The HL7 Retrieval of Real-World Data for Clinical Research implementation guide is dependent on the International Patient Access (IPA) for a baseline dataset.
Refer to FDA’s Data Standards for Drug and Biological Product Submissions Containing Real-World Data for guidance on the use of real-world data (RWD) to generate real-world evidence (RWE) in regulatory decision-making.

Feedback requested

Form Guide

1. Optional: Background Text / Cover Letter

The "Optional Background Text / Cover Letter" field provides space for additional context or introductory information related to your comment.

This field is entirely optional and serves the following purposes:

Provides context for reviewers
Serves as an introduction if submitting multiple comments
Functions as a cover letter for formal submissions

If you are submitting a single comment for a specific data class or element, you may leave this field blank. For multiple comments, this space is useful for explaining the overall purpose or connection between your comments.

Fig 1 The "Optional Background Text / Cover Letter" field allows users to provide contextual information or introductory remarks for their comment submission.

2. Complete the Comment Form

The comment form contains several fields that require your input:

ISA Content: This field is automatically populated based on the page you are currently viewing. No action is required.

Standards and Implementation Specifications: This drop-down menu is pre-selected based on the topic you're commenting on. The selection reflects the relevant standard or implementation specification for your current page.

Subject: Enter a concise title that summarizes the focus of your comment. This helps reviewers quickly understand the nature of your feedback.

Comment: This is the main field where you provide your detailed feedback, concerns, or suggestions. The comment box includes a text editor with formatting options that allow you to:

Format text as bold or italic
Insert hyperlinks
Create bullet points
Create numbered lists
Apply strike-through formatting
Attach images
Insert tables

Use these formatting options as needed to clearly present your information.

Fig 2 The comment text editor toolbar provides formatting options including bold, italic, links, lists, tables, and image insertion capabilities.

3. Optional: Add Additional Comments

If you need to provide feedback on multiple aspects of the ISA content, you can add additional comments:

After completing your first comment, locate and click the link labeled "Comment on another interoperability need" at the bottom of the form.
A new comment section will appear, allowing you to enter details for your additional comment.
For this new comment section, the "ISA Content" and "Standards and Implementation Specifications" fields will not be automatically populated. You must select the appropriate content and specification from the drop-down menus for each additional comment.
Complete all required fields for your additional comment.
Repeat this process for each additional comment you wish to submit.

Fig 3 The "Comment on another interoperability need" link enables users to add multiple comments within a single submission.

4. Optional: Upload Supporting Files

The platform allows you to upload supporting documentation to enhance your comment:

Locate the "File Upload" section at the bottom of the comment form.
Click to upload any files (such as PDFs or documents) that provide additional context, evidence, or clarification for your comment.

Important: If you have already entered your comments using the form fields, there is no need to upload duplicate content in PDF format. The file upload feature is intended for supplementary materials only. Please avoid uploading files that contain the same information already provided in your comment text.

Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.

5. Optional: Save and Exit

If you need to pause your work and return to complete your comment later:

Click the "Save and Exit" button at the bottom of the form.
Your comment will be saved as a draft that you can access and complete later.
When you return to the platform, you will see a red triangle with an exclamation mark next to the "Return to saved Comment" button, indicating that you have saved comments in draft status.
Click the "Return to saved Comment " button to continue working on your draft.
You will be taken to a review page where you can:
1. Select "Submit Comment" to officially submit your feedback.
2. Click "Edit" to return to the comment form and make changes
3. Select "Discard Draft" to delete the saved draft and start fresh

Fig 5 A red triangle with exclamation mark indicator appears next to the "Return to saved Comment" button when draft comments are saved in the system.

6. Review and Submit

Once you have completed your comment:

Click the "Review and Submit" button at the bottom of the form.
This will take you to a review screen displaying your comment(s) in full.
Review all information for accuracy and completeness.
On this review screen, you have three options:
1. Click "Submit Comment" to officially submit your feedback
2. Click "Edit" to return to the comment form and make changes
3. Click "Discard Draft" to delete the comment and start fresh
The review screen also includes a "Print" button that allows you to create a printed copy of your comments for your records.
If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.