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MCA Submission

All new clinical studies will start at the MCA Request regardless of funding sources (ie. Extramural industry or private funding, extramural non-profit or government funding, and/or intramural funding). This includes investigator-initiated, cooperative group, industry, and federal studies. It will then be determined whether an MCA/CA, Calendar only or Study Shell will be required.

Requesting a MCA build

The starting point begins with serious consideration of a study.

1. Send an email to the following recipients: jvillasin@queens.org

with a cc: to sdelacruz@queens.org , dtani@queens.org , ltsue@queens.org , rohta@queens.org.
if the study involves a drug, cc: ids_manamana@queens.org

2. Include the following in the Subject of the email:

MCA Request: [Short Name of Study] [PI]
Example: “MCA Request: CSTUDY Doe”

3. Fill out ONE of the following form and attach to the email:

for new MCA request, fill out the MCA Study Intake Form
to update an existing MCA, fill out the MCA Study Change Form

4. Provide the following soft copy documents as attachments for the applicable study types:

NCI/Cooperative group studies	Pharma/Industry (including Registry/Data Collection type)	Investigator-initiated	Other
Protocol	Protocol	Protocol	Protocol
ICF*	ICF*	ICF*	ICF*
Funding Sheet	Prelim budget	Prelim budget	Prelim budget
NCA** (if there is one)	Prelim contract		Prelim contract
Investigator’s Brochure	Investigator’s Brochure	Investigator’s Brochure
Device Instructions for Use	Device Instructions for Use	Device Instructions for Use
	Lab Manual – mandatory for phase 1 studies	Lab Manual – mandatory for phase 1 studies
	Case Report Forms	Case Report Forms
	Pharmacy Manual
	FDA IDE Letter (Device)
	CMS Category Letter (Device)

* Make note whether the consent is a template or the proposed version for QMC

** NCAs (National Coverage Analysis) are provided for certain Oncology Cooperative Group studies from NCI. It is expected that each institution reviews the NCA and make any modifications that are justified to create an institution MCA.

MCA OR STUDY SHELL COMPLETION

If it is determined that a Study Shell only is required, an entry will be made in Clinical Conductor with the RA number. Final IRB approved documents (eg protocol and ICF) should be provided. Any changes to the study should be notified to Jeremiah.
If it is determined that an MCA is required, then an MCA will be built on an Excel file within 10 business days and will be provided to the Study Coordinator for review, feedback and edits.
Once finalized, the MCA will be provided to the Research Business Office (RBO) or Sponsored Program Office (SPO) for budget negotiations, if necessary

CALENDAR BUILD PROCESS AND COMPLETION

Studies may proceed to Budget Process and Calendar Build where sponsor says for all and no procedures are billed to Insurance/Patient.
Once the budget is finalized, the study calendar will be built in Clinical Conductor
The calendar will be provided to the Study Coordinator within 10 business days for review, feedback and edits in the format of an excel file.
Changes to the MCA/Study Calendar can be made after budget negotiations.

QUESTIONS/CONCERNS:

Contact Jeremiah Villasin at 808-691-4645 or jvillasin@queens.org

Rebecca Ohta at 808-691-4106 or rohta@queens.org