Protocol Creation Sheet, Version 2.1C

Application For Using Imaging Research Facilities

Mallinckrodt Institute of Radiology

Title of Proposed Research
DIRECTIONS: Fill in the Title

Type of Application
DIRECTIONS: Each of the following three fields contain list boxes. Select the appropriate value in each of the boxes. NOTE FOR COMPLETING "SUBMITTED TO": If you are a member of any of the laboratories listed under "Submitted To," select that lab to review your research application unless you are only requesting the use of BJC equipment. If you are only requesting the use of BJC equipment, or if you are not a member of any of the labs listed, select the Clinical Research Laboratory to review your application.
Type of Application	For	Submitted For Review To

Specific Aims
DIRECTIONS: Enter the objective of the study stated as a hypothesis or specific research question. THIS FIELD WILL BE TRUNCATED AT 1600 CHARACTERS (1/3 OF A PAGE)

Background & Significance
DIRECTIONS: Enter a succinct discussion of the importance of the problem, the originality of this approach, and the contribution it will make if successful. THIS FIELD WILL BE TRUNCATED AT 4800 CHARACTERS (1 PAGE)

Preliminary Results
DIRECTIONS: Enter only if available and relevant to the protocol. THIS FIELD WILL BE TRUNCATED AT 4800 CHARACTERS (1 PAGE)

N/A	Description of Tasks Used
	DIRECTIONS: Enter a complete description of the tasks used during each scan(PET) and/or study(fMR). Each description will contain part or all of the following information: ID; NAME; DESCRIPTION; and CATEGORIES to which it belongs.
		The following information needs to be entered for new tasks: ID:(leave blank) NAME: DESCRIPTION: CATEGORY: For tasks currently in the database, enter: ID: task number NAME:

Methods & Data Analysis
DIRECTIONS: Please discuss how the data will be collected and, briefly, how the data will be analyzed. (While there is no page limit for this section, you are strongly encouraged to be concise in describing your experimental techniques)

Sample Size Justification
DIRECTIONS: Explain rationale for number of studies requested.

References Pertinent To This Protocol
DIRECTIONS: (This field is optional.) Enter references pertinent to this protocol. THIS FIELD WILL BE TRUNCATED AT 4800 CHARACTERS (1 PAGE)

N/A	Facilities
	DIRECTIONS: Select the equipment you will be using.Multiple values may be selected. (On Macintoshes, you must hold down the COMMAND key when selecting multiple values. On PC's, you must hold down the CONTROL key when selecting multiple values.) Specify any other facilities required in the space provided.
		Other

N/A	Scanner Room Equipment and Materials
	DIRECTIONS: Select the equipment you will be using. Multiple values may be selected. (On Macintoshes, you must hold down the COMMAND key when selecting multiple values. On PC's, you must hold down the CONTROL key when selecting multiple values.) Specify any other equipment or materials required in the space provided.
		Other

Please confine responses to space allotted on this form and allow at least 2 weeks for review and final decision. The submit button at the end of the form will email this document to the Radiology Research Office. Additionally, a signed hardcopy of this form must be sent to Pat McCosky, Box 8131, in the Radiology Research Office. You will be notified by email after approval and will need to provide any missing information such as approval dates and numbers for all of the relevant committees (Research Review, HSC, RDRC, ASC) before your studies can commence.

Title of Proposed Research

DIRECTIONS: Fill in the Title

Type of Application

DIRECTIONS: Each of the following three fields contain list boxes. Select the appropriate value in each of the boxes. NOTE FOR COMPLETING "SUBMITTED TO": If you are a member of any of the laboratories listed under "Submitted To," select that lab to review your research application unless you are only requesting the use of BJC equipment. If you are only requesting the use of BJC equipment, or if you are not a member of any of the labs listed, select the Clinical Research Laboratory to review your application.

Type of Application For Submitted For Review To

Investigator Information

DIRECTIONS: Only the login name is needed for each investigator. On the first line, enter the login name for the Primary Investigator (the individual primarily responsible for carrying out the specific studies included in this research application). On each additional line, enter the login name for the collaborators. Select the box in the "A" column for each investigator who is authorized to conduct scans under this protocol.

A Login Name Academic Rank, Dept (if Wash U)
Full Address (if not Wash U) Telephone Box # E-Mail

N/A
Other Personnel

DIRECTIONS: Please identify any additional personnel required. Select the title and enter the name and percentage of time required (i.e., "10% over six months"), if applicable.

Title Name Percentage of Time

Keywords

DIRECTIONS: Enter any keywords in the space provided

Specific Aims

DIRECTIONS: Enter the objective of the study stated as a hypothesis or specific research question.
THIS FIELD WILL BE TRUNCATED AT 1600 CHARACTERS (1/3 OF A PAGE)

Background & Significance

DIRECTIONS: Enter a succinct discussion of the importance of the problem, the originality
of this approach, and the contribution it will make if successful.
THIS FIELD WILL BE TRUNCATED AT 4800 CHARACTERS (1 PAGE)

Preliminary Results

DIRECTIONS: Enter only if available and relevant to the protocol.
THIS FIELD WILL BE TRUNCATED AT 4800 CHARACTERS (1 PAGE)

N/A
Description of Tasks Used

DIRECTIONS: Enter a complete description of the tasks used during each scan(PET) and/or study(fMR). Each description will contain part or all of the following information: ID; NAME; DESCRIPTION; and CATEGORIES to which it belongs.

The following information needs to be entered for new tasks:
ID:(leave blank)
NAME:
DESCRIPTION:
CATEGORY:

For tasks currently in the database, enter:
ID: task number
NAME:

Methods & Data Analysis

DIRECTIONS: Please discuss how the data will be collected and, briefly, how the
data will be analyzed. (While there is no page limit for this section, you are
strongly encouraged to be concise in describing your experimental techniques)

Sample Size Justification

DIRECTIONS: Explain rationale for number of studies requested.

References Pertinent To This Protocol

DIRECTIONS: (This field is optional.) Enter references pertinent to this protocol.
THIS FIELD WILL BE TRUNCATED AT 4800 CHARACTERS (1 PAGE)

N/A
BJC Clinical Equipment

DIRECTIONS: For equipment located in the hospital, enter the equipment in the boxes on the right, next
to the appropriate location.

BJC North

BJC South

Childrens

Other

N/A
Facilities

DIRECTIONS: Select the equipment you will be using.Multiple values may be selected. (On Macintoshes, you must hold down the COMMAND key when selecting multiple values. On PC's, you must hold down the CONTROL key when selecting multiple values.) Specify any other facilities required in the space provided.

Other

N/A
Scanner Room Equipment and Materials

DIRECTIONS: Select the equipment you will be using. Multiple values may be selected. (On Macintoshes, you must hold down the COMMAND key when selecting multiple values. On PC's, you must hold down the CONTROL key when selecting multiple values.) Specify any other equipment or materials required in the space provided.

Other

Protocol Budget

DIRECTIONS: The Protocol Budget section is divided into three main sections: MIR Research Facilities, BJC Clinical Equipment, and Additional Supplies. ONLY fill out the sections that apply. Check N/A for those sections that do not apply.

MIR Research Facilities

N/A Facilities (including Technical Support) Charged by the Hour

DIRECTIONS: Use the select boxes to pick the scan description, the scanning time and the scanner. Enter the requested number of hours. DO NOT ENTER THE OTHER FIELDS. They will be returned to you when SAVE or SUBMIT (located at bottom of form) is selected. NOTE: A "C/S" (cost sharing) will be returned for Rate if the scanner selected is a PET scanner.

Category--Description Scanning Time Scanner Time
(hrs) Rate ($/hr) Amount

Totals

N/A Examinations Charged by Exam Code

DIRECTIONS: Use the select boxes to pick the description and scanner. Enter in the requested number of exams. DO NOT ENTER THE OTHER FIELDS. They will be returned to you when SAVE or SUBMIT (located at bottom of form) is selected.

Exam Code--Description Scanner Requested
Number Rate ($/exam) Amount

Totals

Funds Allocated

DIRECTIONS: If either of the total amounts above is greater than $0, then complete the IDO (Interdepartmental Order) Request Form (available seperately), submit a copy to your accounting personnel and transfer the following entries to this page. [Blanket Order IDO Request form for The MR Facility: Microsoft Word 6.0 (Mac, PC), Word Perfect 6.1 (PC) (Hold Down The Shift Key And Click To Download From Netscape)] IDO Number Order Amount IDO Expiration
Date (mm/dd/yy)

Grants

DIRECTIONS: If the funding for your studies is provided by a grant, please select the grant(s) in the spaces below. It is possible to identify up to 3 gran ts. If your grant is not listed and you wish to identify it, please enter the name in the space provided.

If needed, please enter unlisted or additional grant name(s) here:

BJC Clinical Equipment

DIRECTIONS: Use the select boxes to pick the category of study to be completed. Under "Exam Description," enter a short description of the exam. If the exam code is known, please enter it in the third column. Finally, enter in the requested number (if human study) or requested hours (if animal study) for this exam.

N/A Human Studies

Category Exam Description Exam
Code Requested
Number

Total

N/A Animal Studies

Category Exam Description Exam
Code Requested
Number

Total

Clinical Research Departmental Funding

If you are requesting Department Funding for Pilot Studies, please enter the amount (in $) in the space provided.

Clinical Research Discount Request

If you are requesting a discount to be applied to this research, please enter the percentage (10, 15, 20, ...) in the space provided.
NOTE: The maximum discount allowable is 30% for commercially funded studies and 38% for federally funded studies.

Clinical Research Contact Information

DIRECTIONS: Please enter all appropriate contact information for billing purposes. (For clinical research studies, this person may or may not be the primary investigator.)

Name

Address

Phone Number
Department
Account Number

N/A Additional Supplies Requested

DIRECTIONS: Please type in the additional supplies required and the cost of those supplies.

Description Amount ($)

Total

N/A
Investigator Certification

DIRECTIONS: DO NOT ENTER ANY INFORMATION INTO THIS SECTION. This section will retrieve (from the database) the names of all collaborators who have passed MR Certification and the Radiation Safety Exam. All investigators conducting the experiments must be certified on the equipment used in the protocol.

MR Certification:

Radiation Safety Exam:

N/A
Human Studies Committee Approval

DIRECTIONS: Fill in and set the appropriate values.

Approval Status
Date of approval (mm/dd/yy)
HSC Number

N/A
Approval for Using and Administering Radioactive Materials

DIRECTIONS: If this protocol does not require the use of radioactive material, please select the "N/A" box and proceed to the next section. If radioactivity is involved in the study, list the name of the collaborator who is the Radiation Safety Committee Approved User of the radioactive material(s). If it is a human study, fill in the appropriate Radioactive Drug Research Committee Approval information.

Authorized User

Name

Expiration Date (mm/dd/yy)

Radioactive Drug Research Committee Approval (Human Studies Only)

Approval Status
Date of Approval (mm/dd/yy)
RDRC Number

N/A
Animal Studies Committee Approval

DIRECTIONS: Fill in and set the appropriate values.

Approval Status
Date of approval (mm/dd/yy)
ASC Number

Investigator Signature Blocks

Following are the signature blocks for the Primary Investigator and the Principal Investigator.
Each block explains who must sign in that space. However, please note that if this Research
Application is for studies without funding, such as pilot studies, only the Primary Investigator
block needs to be signed. Additionally, if the Primary Investigator and the Principal Investigator
are the same person, only the Principal Investigator block needs to be signed.

Signature of Primary Investigator

The Primary Investigator is the individual responsible for coordinating the proposed study from
experimental setup through data acquisition and final data analysis. This investigator is normally
the first author listed on the study. No signature is needed in this section if this investigator is also
the Principal Investigator (see below).

Name Date (mm/dd/yy)

Signature of Principal Investigator

The Principal Investigator is the individual who is approving the use of funds directly under his/her
control for the costs associated with the proposed study.

Name Date (mm/dd/yy)

Review Committee Chairman Signature

Name Date (mm/dd/yy)

Protocol Number

Protocol Number Assigned by Research Committee:

Save

Submit for Review

Editorial Comments

DIRECTIONS: This field is for comments by the approval committee and responses
from the primary investigator.

Investigator Information
DIRECTIONS: Only the login name is needed for each investigator. On the first line, enter the login name for the Primary Investigator (the individual primarily responsible for carrying out the specific studies included in this research application). On each additional line, enter the login name for the collaborators. Select the box in the "A" column for each investigator who is authorized to conduct scans under this protocol.
A	Login	Name	Academic Rank, Dept (if Wash U) Full Address (if not Wash U)	Telephone	Box #	E-Mail

Other Personnel
DIRECTIONS: Please identify any additional personnel required. Select the title and enter the name and percentage of time required (i.e., "10% over six months"), if applicable.
Title	Name	Percentage of Time

N/A	BJC Clinical Equipment
	DIRECTIONS: For equipment located in the hospital, enter the equipment in the boxes on the right, next to the appropriate location.
	BJC North
	BJC South
	Childrens
	Other

Protocol Budget
DIRECTIONS: The Protocol Budget section is divided into three main sections: MIR Research Facilities, BJC Clinical Equipment, and Additional Supplies. ONLY fill out the sections that apply. Check N/A for those sections that do not apply.
MIR Research Facilities
N/A	Facilities (including Technical Support) Charged by the Hour
	DIRECTIONS: Use the select boxes to pick the scan description, the scanning time and the scanner. Enter the requested number of hours. DO NOT ENTER THE OTHER FIELDS. They will be returned to you when SAVE or SUBMIT (located at bottom of form) is selected. NOTE: A "C/S" (cost sharing) will be returned for Rate if the scanner selected is a PET scanner.
	Category--Description	Scanning Time	Scanner	Time (hrs)	Rate ($/hr)	Amount





	Totals
N/A	Examinations Charged by Exam Code
	DIRECTIONS: Use the select boxes to pick the description and scanner. Enter in the requested number of exams. DO NOT ENTER THE OTHER FIELDS. They will be returned to you when SAVE or SUBMIT (located at bottom of form) is selected.
	Exam Code--Description		Scanner	Requested Number	Rate ($/exam)	Amount





	Totals
	Funds Allocated
	DIRECTIONS: If either of the total amounts above is greater than $0, then complete the IDO (Interdepartmental Order) Request Form (available seperately), submit a copy to your accounting personnel and transfer the following entries to this page. [Blanket Order IDO Request form for The MR Facility: Microsoft Word 6.0 (Mac, PC), Word Perfect 6.1 (PC) (Hold Down The Shift Key And Click To Download From Netscape)]			IDO Number	Order Amount	IDO Expiration Date (mm/dd/yy)

	Grants
	DIRECTIONS: If the funding for your studies is provided by a grant, please select the grant(s) in the spaces below. It is possible to identify up to 3 gran ts. If your grant is not listed and you wish to identify it, please enter the name in the space provided.

	If needed, please enter unlisted or additional grant name(s) here:

N/A	Additional Supplies Requested
	DIRECTIONS: Please type in the additional supplies required and the cost of those supplies.
	Description				Amount ($)





	Total

N/A	Investigator Certification
	DIRECTIONS: DO NOT ENTER ANY INFORMATION INTO THIS SECTION. This section will retrieve (from the database) the names of all collaborators who have passed MR Certification and the Radiation Safety Exam. All investigators conducting the experiments must be certified on the equipment used in the protocol.
	MR Certification:
	Radiation Safety Exam:

N/A	Human Studies Committee Approval
	DIRECTIONS: Fill in and set the appropriate values.
	Approval Status
	Date of approval (mm/dd/yy)
	HSC Number

N/A	Approval for Using and Administering Radioactive Materials
	DIRECTIONS: If this protocol does not require the use of radioactive material, please select the "N/A" box and proceed to the next section. If radioactivity is involved in the study, list the name of the collaborator who is the Radiation Safety Committee Approved User of the radioactive material(s). If it is a human study, fill in the appropriate Radioactive Drug Research Committee Approval information.
	Authorized User
	Name
	Expiration Date (mm/dd/yy)
	Radioactive Drug Research Committee Approval (Human Studies Only)
	Approval Status
	Date of Approval (mm/dd/yy)
	RDRC Number

Signature of Primary Investigator
The Primary Investigator is the individual responsible for coordinating the proposed study from experimental setup through data acquisition and final data analysis. This investigator is normally the first author listed on the study. No signature is needed in this section if this investigator is also the Principal Investigator (see below).
Name	Date (mm/dd/yy)

Signature of Principal Investigator
The Principal Investigator is the individual who is approving the use of funds directly under his/her control for the costs associated with the proposed study.
Name	Date (mm/dd/yy)