MK Packages
This package is used when there is a change in Box 6 of the 1572 (no other changes were made).
What is an SMU Package?
This type of package is used when there is a change to the investigator in Box 1 of the 1572.
What is a PI Change Package?
These reports are posted monthly by the CTC to the SCOT for the CRM to review?
What is the Protocol Deviation Report, Open Action Items, and CTMS Missing Data (FOCUS) Report?
This tracker is used to ensure that CRAs/CRMs have completed all training required for the study.
What is the Protocol Specific Training (PST) Tracker?
This communication is sent out to sites within 14 days after site ready.
What is the Post Initiation Site Letter/Email?
These documents are available to walk CTCs step by step through the package process.
What is the CTC Package Checklist?
This package is specific to Vaccine studies only.
What is an IB/Amendment Package?
This report is used to check the site staff that are affiliated with a site in Spectrum and can be used when sending out monthly maintenance emails.
What is the Site Profile Report?
The spirit of this tracker is that CRAs, CRMs and COMs can find documents following the same structure for all trials.
What is the Study Document Tracker?
A Satellite Site receiving IP with it's own unique number would be listed under this box of the 1572.
What is Box 3?
A CTC receives an updated 1572 adding a new Sub-I to the 1572. This form is completed to add contact to Spectrum.
What is the Additional Accounts and Contacts Request Form?
You received an updated 1572 adding a Nurse Practitioner to Box 6 of the 1572. The CV for the new Sub-I does not show affiliation to the site. This is required.
What is an updated CV or NTF?
This report is used to reconcile all MyLearning Training on the Protocol Specific Training Tracker?
What is the MyLearning Curriculum Compliance Report?
This report is used to ensure that the number of documents expected matches what is actually filed in Veeva Vault.
What is the Essential Document List Report (EDL)?
An updated financial disclosure form would be required from a PI or Sub-I when this takes place.
What is a change in financial interest?
The approval of the package triggers a notification that goes to this group to determine if the event is reportable to the FDA.
What is the Worldwide Regulatory Coordination (WRC)?
You are a CTC working on a Vaccine Study. You recently received a notification from Advarra (the central IRB) stating that a site received approval for an updated Main ICF due to an updated patient stipend. This action is required from the CTC.
What is create an SMU Package?
This report is used when conducting a soft Clinical Study Review.
What is the List of Investigators and Independent Ethics Committees report?
A CTC is responsible from reconciling these documents on the EDL:
What are the:
Confidentiality Disclosure Agreement
Protocol Signature Page
Principal Investigator Curriculum Vitae
Sub-Investigator Curriculum Vitae
Statement of Investigator (1572)
Financial Disclosure Form
Non-Critical FDA 1572 Updates*
Data Privacy Agreement*
Essential Document Approval Form (EDA)
Site and Staff Qualification Supporting Information - PIQSD*
This report is used to verify that site staff have the appropriate access and training to necessary systems in accordance to their role on the study.
What is the Provisioning Dashboard and Error Report?
You are a CTC working on an MK study. You received an updated 1572 with a new PI listed in Box 1 (who has not previously worked on this study). These documents need to be in approved status in Veeva Vault prior to approving the package.
What is the updated 1572, Protocol Signature Page, CV for the new PI, FDF, IRB approval letter with new PI, IRB approval letter for updated ICFs, updated ICFs with new PI name, HIPAA (if separate document).
You are a CTC working on an Vaccine study. You recently received an updated 1572 from site that listed a new investigator in Box 1 of the 1572. No other changes were made to the 1572. These documents are attached as supporting documents to your package.
What is 1572, PI CV, IRB Approval of PI, IRB Approval of ICF(s), Main ICF, FBR ICF (if applicable)?
When sending out the CTMS Missing Data report to the study team this data is color coded purple?
What is Data Due within 1 week?
This report can be used to ensure that CVs and FDFs filed in Veeva Vault are captured on the PI/SubI Tab of the CTC Package Tracker?
What is the CTC Site End-To-End Primary and Sub I Investigator Report?
While reconciling Veeva Vault, Jenny the CTC, notices that there are missing SMU packages for 1572s filed. There are also missing CVs and FDFs for staff added on the affiliated 1572s. The following steps are required by Jenny to resolve these findings. Review the steps below and list them in sequential order.
A) Once TDOS filing confirmation email is received update the CTC Package Tracker under the SMU Package Tab and the PI and Sub-I Tab
B) Review SPECTRUM for active staff under the contacts tab and for any missing Sub-Investigators submit the Additional Contacts and Accounts form with the missing Investigators information to CTMS DE.
C) Follow up with the site and/or CRA with a list of missing documents (CVs and FDFs).
D) Submit a SMU Package request to TDOS for the filed 1572s and attach any missing CVs and/or FDFs.
What is B. C. D. A?