Process Notes
The estimated MW QC Check Duration (business days) for a protocol with an operations manual.
What is 2 business days? (Table 1 of the PNs)
On the MWQC Smartsheet, this is the default status for new documents, representing a document still waiting for all QC resources to be assigned.
What is Not Assigned?
Lot Genealogy Reports are located here.
What is Vault?
RDQA
What is Research and Development Quality Assurance?
Lot number information in CSRs
What is subject to QC?
The number of business days before QC of a document begins in which the assigned QC lead will send a pre-QC checklist
What is 1-2 days? (Section 5.2.1 of the PNs)
On the MWQC Request Smartsheet, MWQC staff should assign themselves as QC Lead, Additional QC, or this role.
What is QC Support?
This type of protocol typically has a master study and at least 1 sub-study.
What is an APEX protocol?
RIMS
What is Regulatory Information Systems?
Four subjects (12%) experienced a serious adverse event (SAE) of nausea.
What is subject to QC?
The number of business days MW will submit a QC request before the expected MW QC start date
What is 5? (Section 5.2.1 of the PNs)
The four document types that require Additional QC when audited.
What is CO, CSE, CSS, and CSR?
For a CSR, the Lead QCer is responsible for filling this out and saving this Assignment Matrix in the Strategic Medical Writing SharePoint.
What is the QC Assignment Matrix Template?
QDP
What is Quality Dossier Program?
In the X+ Y arm, the higher rates of anemia, blood bilirubin increased, and hyperuricemia were likely due to the hemolytic effect of Y.
What is not subject to QC
This role is performed by internal QC staff for documents that are scheduled for RDQA audit and documents that did not meet RDQA audit acceptance criteria. It occurs in RIMS in-parallel with the primary QC. It does not require an additional checklist.
What is Additional QC? (Section 5.2.4.1 of the PNs)
This is defined as last minute/additional edits of a document that has not 100% made it through QC review.
What is Re-Work?
This document type is a general overview of Safety Information over a 1-year reporting period and is generally comprised of an Executive Summary, Body, and Appendices.
What is a DSUR?
IDE
What is Investigational Device Exemption?
No clinically important trends in clinical chemistry variables were observed in the mean changes from baseline over time.
What is not subject to QC?
You can find information about MW QC Checklists (document titles, form numbers, and if available as full document processing) in this section of Process Notes.
What is Appendix A?
The General Pre-QC Checklist is for Documents other than these 3 document types.
What are IBs, DSURs, or CSRs?
For clinical summary documents (CO, CSS, CSE), it is best practice to use original TLG source outputs (instead of approved CSR or Summary Documents) to perform QC for this reason.
What is to prevent errors that may not have been resolved in the approved documents?
CIOMS
What is Council for International Organizations of Medical Science?
This trial is a multi-center, randomized, double-blind Phase 2 study in patients with moderately to severely active Crohn's disease.
What is not subject to QC? (Introductory information, mode of action, etc. is not subject to QC, per Section 5.2.2 of the PNs.)