Radiology Logistics Implementation Review

Radiology Logistics Implementation Review

Protocol Name: / Click here to enter text.
CRU: / Click here to enter text.
Title of study: / Click here to enter text.
Sponsor: / Click here to enter text.
PI name and info: / Click here to enter text.
Radiologist collaborator name: / Click here to enter text.
Study coordinator name and info: / Click here to enter text.
Regulatory coordinator name and info: / Click here to enter text.
Financial coordinator name and info: / Click here to enter text.
eIRB #: / Click here to enter text. / IRB start date: / Click here to enter text.
How will Imaging be Billed? / Click here to enter text. / Notes concerning billing / Click here to enter text. /
Is the study NIH funded? (Please include group or corporate code) / Click here to enter text. /
Imaging CRO name and contact information (if applicable): / Click here to enter text.
Site Survey / Choose an item. / Form included? / Choose an item.
De-IDENTIFICATION required? / Choose an item. / RECIST / Choose an item.
Modalities Involved with study / Click here to enter text.
Parts of Protocol that are research s (nonclinical ) / Click here to enter text.
Parts of Protocol that are clinical scans / Click here to enter text.

Role of Scanning Staff:

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II. IMAGING MODALITY REQUIRED:

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Name of Modality Reviewer: / Click here to enter text. /
Is this an existing Radiology Clinical Protocol? / Choose an item. / Ability to do this study? / Choose an item.
Are there extra processes/effort that are not standard of care? / Choose an item. / Is there Tech training / Choose an item.

Additional comments:Click here to enter text.

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Name of Modality Reviewer: / Click here to enter text. /
Is this an existing Radiology Clinical Protocol? / Choose an item. / Ability to do this study? / Choose an item.
Are there extra processes/effort that are not standard of care? / Choose an item. / Is there Tech training / Choose an item.

Additional comments: Click here to enter text.

Choose an item.

Name of Modality Reviewer: / Click here to enter text. /
Is this an existing Radiology Clinical Protocol? / Choose an item. / Ability to do this study? / Choose an item.
Are there extra processes/effort that are not standard of care? / Choose an item. / Is there Tech training / Choose an item.

Additional comments: Click here to enter text.

PET:

Name of Modality Reviewer: / Click here to enter text. /
Is this an existing Radiology Clinical Protocol? / Choose an item. / Ability to do this study? / Choose an item.
Are there extra processes/effort that are not standard of care? / Choose an item. / Is there Tech training / Choose an item.
Protocol Development? / Choose an item. / Extra fees / Click here to enter text. /
Oversight of each scan required? / Choose an item. / Phantom required? / Choose an item.

Additional comments:Click here to enter text.

III . DATA HANDLING:

Multi D Lab (de-ide, RECIST & other measurements) services?
It is suggested to schedule the RECIST read by calling the Multi-D Laboratory (919-681-0492) at the time of scheduling the clinical procedure. / Click here to enter text. /
Transfer to sponsor via cd/dvd? / Choose an item.

Additional comments: Click here to enter text.

1. RADIOLOGIST INVOLVEMENT:

Name of Faculty Radiologist / Click here to enter text. /
Manual Reference Page / Click here to enter text. /
Protocol Development Required? / Choose an item. / # Hours of Effort ($500.00 per hour) / Click here to enter text. /
Radiologist Oversight of each Scan Required? / Choose an item. / Reading for Incidental Findings
(If primary interpretations done centrally) / Click here to enter text.
Scoring Sheet or Case Report Form (CRF) needed? / Choose an item.

Role of Radiologist: Click here to enter text.

1. BUDGET OVERVIEW:

Billed to Grant or Insurance? / Click here to enter text. /
CPT Code for scans / Click here to enter text. /
Charge / Fee
PROTOCOL REVIEW / Choose an item. /
RECIST tumor measurements / Choose an item. /
Data De-identification / (681-0492)
Fees for CD/De-identification / Choose an item. /

Summary of other roles:

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Please note it is the PI's (coordinators) responsibility to notify the appropriate Radiology division contact approximately four (4) weeks prior to study enrollment. This allows time to properly prepare imaging equipment and staff members to initiate your protocol. Additional clinical trial study requirements, phantoms, training for imaging staff should be scheduled with division contacts allowing time to train all relevant staff.

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Radiology Review Form Version 4.2 Please return via email to