Feb 13th - updated
BR&R Only
1439 | Reaffirm HL7 Version 3 Standard: Regulated Studies - Annotated ECG, Release 1 | OK |
| 1425 | CDISC LAB Semantics in FHIR | OK |
| 1310 | BRIDG v20190115v2 - May 2019 release | OK |
1240 | RCRIM FHIR Resources and Profiles | Can be closed |
936 | Clinical Study Functional Profiles UPDATE to harmonize with EU | Can be closed |
833 | Regulated Product Submission Release 2 Draft 2 (RPS R2D2) | Can be closed |
720 | Regulatory Activity Submission Hierarchy (RASH) | Can be closed |
718 | Clinical Study Functional Profiles | Can be closed |
716 | Clinical Trial Registration and Reporting R2 (CTR&R-R2) | Can be closed |
BR&R With OO
1368 | Pharmaceutical Quality/Chemistry Manufacturing & Controls (PQ/CMC) | Smita/Boris still doing some work, work continues at a low level - this is effectively an umbrella project |
1339 | Structured Product Labeling (SPL R9) | Can be closed Sent to OO for agreement |
1367 | FHIR resources to support IDMP 11615 Product Standard | Sort with Rik Keep project - review scope |
BR&R With Patient Care
1229 | Structured Product Labeling for Food (SPL R8) | Can be closed Sent to PC for agreement |
New - to Sept 2020
| 1531 | BRIDG 5.4 | Placeholder |
| 1537 | PQ/CMC | Active |
| 1540 | sIRB | Active |
| 1574 | BRIDG 2020 | Placeholder |
| 1644 | Transfusion & Vaccination AE IG | Active |
BR&R Co-Sponsor
1433 | Patient Reported Outcomes (PRO) | Dragon will provide status |
1422 | FHIR Resources for Evidence-Based Medicine Knowledge Assets (EBMonFHIR) | OK Had report back in San Antonio |
| 1416 | Exploration of FHIR resources for IDMP | Sort with Rik Keep project - review scope |
1390 | Structured Data Capture Update (SDC) | OK - Lloyd will report back in April |
1292 | Specimen DAM Update | Asked Riki for status |
1265 | Data Access Framework (DAF) FHIR Implementation Guide | Asked Dragon for status |
| 1426 | Women's Health Technology Coordinated Registry Network (CRN) | OK ballot in May |
| 1424 | Common Data Model Harmonisation (CDMH) | OK balloting in May |