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Regulated Product Submissions Release 2 Iteration 1 Design

Regulated Product Submissions Release 2 Iteration 1 Design. January 12th HL7 WGM Jason Rock Jason.Rock@GlobalSubmit.com 215-253-7473. Contents. Health Level 7 (HL7) Development Two way communication Contact information Product information. Reference Information Model (RIM).

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Regulated Product Submissions Release 2 Iteration 1 Design

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  1. Regulated Product SubmissionsRelease 2 Iteration 1Design January 12th HL7 WGM Jason RockJason.Rock@GlobalSubmit.com215-253-7473

  2. Contents • Health Level 7 (HL7) Development • Two way communication • Contact information • Product information

  3. Reference Information Model (RIM) • Built for health care • One big data model • Basis for all HL7 messages • Model driven development

  4. RIM Organization • System to system communication • Informs systems of entities (e.g. person) • that plays a role (e.g. surgeon) • that participates (e.g. perform) • in an action (e.g. surgery)

  5. Two-way communication • Status of regulatory activity • Organization of Submissions • e.g.; amendment is a supplement • Other content • e.g.; meeting request, questions, letters, etc.

  6. Mechanics • Regulator send RPS to Sponsor • Can update submission hierarchy • Can update status • Can provide content • e.g. letters, questions • New: title to submission unit

  7. Status of Regulatory Activity • Status code attribute • Withdrawn • Complete (approved) • Held (clinical hold) • etc.

  8. Context of Use • Pointer to a file (FileReference) • e.g.; like a hyperlink to a file • Link to table of contents (code) • Create versions of a document (setId) • Many in a submission unit

  9. Other content • If it walks and talks like a context of use…. • Many in a submission • Has a title • Has a type • Points to a file • New: Can be linked

  10. New: Category • Submission unit code • If initial, amendment, etc • Category event • Type of content in a submission • E.g.; IND Acknowledgement/Grant 30-Day Waiver

  11. New: Contact Information • Submission and Submission Unit • “Role” • Different Types of Contents (code) • Contacts change over time (statusCode)

  12. Person or Organization • Contact “Role” plays Person or Organization • Contact entity can be reused (Id) • Complex attributes • (e.g.; telcom is fax, work phone, etc.) • A person is an Agent

  13. New Product Information • Submission is a Regulatory Activity • Submission is for one or more products • HL7 has a common product model • Participants from SPL, ICSR and pharmacy

  14. Common Product Model

  15. RPS Model

  16. Contents • Health Level 7 (HL7) Development • Two way communication • Contact information • Product information

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