Reg Objects 1
ARC-27 New Investigators Q2 2024
ARC-27 Clinical Study Support
Other: Notice of Noncompliance Site 100204 ARC-10
ARC-10 Clinical Study Support
AB154 DSUR 6 (01Aug2023 - 31Jul2024)
IND Annual Reports
AB154 Investigator's Brochure 8.0
IND XXXXXX AB154 IB 8.0
AB801 DSUR 1 (13Sep2023 - 12Sep2024), and Change in Contact
IND Annual Reports
Letter of Authorization IST Massachusetts General
IND XXXXXX Non-Study Application Support
Response to questions
An RTQ submission should be housed under the same RO as its related Application/Lead submission and RFI record.
AB122CSP0002 - CSR
AB122CSP0002 Clinical Study Support
Initial IND Submission
[Study Name] Protocol - Original IND
ARC-27 Protocol v3, ICF v3, Info Amend, Q1 2024 New Investigators & TORO
ARC-27 Protocol 3.0
Protocol Amendment ARC-4 v11.0
IND XXXXXX ARC-4 Protocol 11.0
New Study/Protocol added to existing IND
[Study Name] Protocol
AB801 CMC IND Amendment
Going forward CMC updates should get their own RO. The M3 Update RO will be retired.
0015 - AB122 DSUR 7 (03Mar2024 - 31Jul2024) - Cross-ref to 138933-0276
Going forward all X-references will be bucketed under a single X-ref RO. This includes but is not limited to (IB X-refs, CMC Amendment X-refs, and DSUR X-ref). RI&S will clean up all the past submissions/ROs in an upcoming data quality project.
STAR-221 Type C Format & Content Meeting Request and Change in Contact
As this submission relates to a meeting, it will get its own Meeting RO. However, if the meeting topic is closely related to an RO that already exists, then you can use that previously created RO.