Submission of Clinical Research Data to FDA to Support Product Marketing Applications

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Type Standard / Implementation Specification Standards Process Maturity Implementation Maturity Adoption Level Federally required Cost Test Tool Availability
Standard
Final
Production
Rating 5
Yes
Free
Yes
Standard
Final
Production
Rating 3
Yes
Free
N/A
Standard
Final
Production
Feedback Requested
No
Free
Yes
Standard
Final
Production
Rating 1
No
Free
N/A
Standard
Final
Production
Rating 5
Yes
Free
N/A
Standard
Final
Production
Rating 3
Yes
Free
N/A
Implementation Specification
Final
Production
Rating 1
No
Free
N/A
Standard
Final
Production
Rating 1
Yes
Free
N/A
Standard
Final
Feedback requested
Feedback Requested
No
Free
No
Emerging Implementation Specification
Balloted Draft
Feedback requested
Feedback Requested
No
Free
No
Limitations, Dependencies, and Preconditions for Consideration Applicable Value Set(s) and Starter Set(s)
  • Feedback Requested

Comment

OMOP CDM

AllOfUs research project is not using CDISC standards. Since it uses RWE, it chose to adopt OMOP CDM. OMOP should be added to the list with medium adoption. (adoption measured by sites generating the data)

On behalf of Wayne Kubick,…

On behalf of Wayne Kubick, CTO of HL7: "Row 3 - ODM is not accepted for regulatory submissions.  It’s true it has a high adoption level for other contexts, but it should be 1 for regulatory submissions 

Row 8 for Therapeutic Area Standards lists Process Maturity as Final, Implementation maturity as Production. But, in fact, this refers to a whole series of IGs, some of which are in development as draft, some provisional (not quite final).  It’s not appropriate to lump them together and adopt the most mature value, but you don’t want to separate them out either. I would change these values to Need Feedback or to some indication the they vary.  The phrase “apply across all therapeutic areas” is not correct.  They haven’t addressed, all, only some.

 In the comments section here, the statement "although CDISC standards are a requirement for CDER and CBER and not for CDRH,  all three Centers promote the use of Real World Data (RWD) in EHRs, registries, administrative claims and mobile health technology to generate Real World Evidence regarding the safety and effectiveness of medical products” implies that CBER, CDER and CDRH use CDISC for real world data.  That’s not accurate.  Instead, the secant should say “FDA CDER, CBER and CDRH promote the use of Real World data (RWD) in EHRs…. 

A comment from AllofUS makes a similar point."