Forms and Policies

Contracts and Clinical Research

Resource	Description
Extramural Project Intake Form	A form that provides basic information about the study and approval from the division to perform the study. A completed intake form is required for all industry sponsored clinical trial/research projects.
Material Transfer Agreement (MTA)/Data Use Agreement (DUA) Intake Form	A form that provides basic information about the study and approval from the division to send or receive data or material. A completed intake form is required for material and/or data transfers.
Service Agreement/Equipment Purchase Agreement Questionnaire	A form used to request new service, equipment, and software purchases. The purchase must be for research purposes.
Request for Residual Funds	Residual funds are unobligated, unspent cash balances remaining in a privately funded fixed-price sponsored project cost center at the conclusion of an award.
CHLA Clinical Trials Next-Generation Therapy Definition	Next-generation therapies address significant unmet medical needs and offer transformative potential for various diseases. See document for Clinical Trials Next-Generation Therapy definition.

Grants

Resource	Description
Extramural Project Intake Form	The Extramural Project Intake Form is an approval by the PI and Department/Division Administrator attesting to certain assurances, and provides pertinent information about the application to ensure appropriate review and submission. A completed intake form is required for all extramurally funded grant applications.
Grants Intake Form for Intramural Awards	The Grants Intake Form For Intramural Awards is an approval by the PI and Department/Division Administrator attesting to certain assurances, and provides pertinent information about the application to ensure appropriate review and submission. A completed intake form is required for all intramurally funded grant applications.
CHLA Budget Template (NIH)	To be used for NIH proposals only. *A completed budget template is required for all extramurally funded projects.
CHLA Non-NIH MTDC Budget Template	To be used for non-NIH MTDC proposals only. *A completed budget template is required for all extramurally funded projects.
CHLA TDC Budget Template	To be used for non-NIH TDC proposals only. *A completed budget template is required for all extramurally funded projects.
Subrecipient Commitment Form	This form is required for all proposed Non FDP Expanded Clearinghouse subrecipients at the time of proposal submission.
Incoming Grant Transfer Checklist	To be used when submitting a Transfer Application.
FDP Expanded Clearinghouse Letter of Intent	This form is required for all proposed FDP Clearinghouse subrecipients at the time of proposal submission.
FDP Clearinghouse-Finding an Organization Job Aid	A job Aid on how to find participants of the FDP Expanded Clearinghouse.
Cost Share/IDC Waiver Form Indirect Cost Waiver Calculator	Cost sharing or an indirect cost (IDC) waiver may be requesting by an investigator or funding agency for a specific project. Please ADM 057.0 (Cost Sharing) or ADM 241.0 (Indirect Costs), as applicable, prior to requesting cost sharing or an IDC waiver. When requesting and IDC waiver please to be sure to complete and include the Indirect Cost Waiver Calculator.

Space and Facilities

Resource	Description
The Saban Research Institute Space Assignment Guidelines	The purpose of this document is to outline a set of principles and procedures to help guide the allocation of research and office space in the Saban Research building (Saban) and Smith Research Tower (SRT) at CHLA. The guidelines are designed to assign space to a Principal Investigator (PI), defined as a faculty member in the Keck School of Medicine who has an active research program that (a) is supported by extramural research funding and/or (b) is supported by start-up funds.
Research Space Request Form	The designated form to request research and office space in the Saban Research building (Saban) and Smith Research Tower (SRT) at CHLA.

Resource

Description

The Saban Research Institute Space Assignment Guidelines

The purpose of this document is to outline a set of principles and procedures to help guide the allocation of research and office space in the Saban Research building (Saban) and Smith Research Tower (SRT) at CHLA.
The guidelines are designed to assign space to a Principal Investigator (PI), defined as a faculty member in the Keck School of Medicine who has an active research program that (a) is supported by extramural research funding and/or (b) is supported by start-up funds.

Research Space Request Form

The designated form to request research and office space in the Saban Research building (Saban) and Smith Research Tower (SRT) at CHLA.

Post Award and Research Finance

Resource	Description
Intramural Project Setup Request Form	A form to set-up a new intramural projects which are linked to net asset accounts
List of General Ledger Expense Accounts	A list of general ledger expense accounts most often used
Reconciliation Workbook Template	A tool to reconcile extramurally funded projects' expenses and adjustments. This also facilitates in generating invoices and information required for the Federal Financial Report (FFR)
Journal Creation Procedure	Process detailing the steps in creating a journal and uploading it to PeopleSoft
Guidelines for Cost Transfers	The Cost Transfer Policy covers both wage and non-wage transfers. To transfer expenses that were inadvertently charged to a project and has to be retroactively moved and charged to the correct project. The division has to prepare a journal to this effect and forward it to the post award analyst.
Request for Residual Funds	Residual funds are unobligated, unspent cash balances remaining in a privately funded fixed-price sponsored project cost center at the conclusion of an award.
Non-wage Expense Transfer Form	A form to capture the summary of expenses other than payroll, being transferred to and from departments, with required approvals, period of transfer and reason for such transfer
Payroll Expense Transfer Form	This is a form to process payroll expense transfers. Departments process payroll expense transfers in cases where the original payroll expense was charged to the wrong account and the department needs to correct it.
Participant Cash Fund Request Form	A form requesting TSRI approval to obtain gift cards and/or funds which are expensed to research projects, to distribute to participants who enroll in studies
Carryforward Request Form	A form to transfer unused funds from one budget period to the next budget period within a project
Rebudget Request Form	A form for modifying the budget of a single period within a project
Request for Advanced Spending Form	When a delay in receiving an award is expected, or on a federal award which allows pre-award spending, Advanced Spending allows expenditures to be charged to the correct project and therefore limits cost transfers and retroactive personnel actions. Also reference policy: FIN – 059.0 Sponsor Authorized Pre-Award Spending and Requests for Advanced Spending (RAS)
Change in PI Form	A form for when a change in principal investigator is needed on any given project.
Financial Report Template	A financial report template to be used only in the case where the sponsor does not have their own standard financial report template.

Technology Commercialization

Resource	Description
ADM 142.0 - Intellectual Property Policy – For Invention and Copyright Disclosures prior to December 2, 2020	This policy is applicable prior to December 2, 2020. The purpose of the policy is to educate faculty, staff, students, and visitors about their rights and responsibilities regarding intellectual property and inventions.
EGEN – 013.0 - New Intellectual Property Policy – For Invention and Copyright Disclosures after December 2, 2020	This policy is applicable after December 2, 2020. The purpose of the policy is to educate faculty, staff, students, and visitors about their rights and responsibilities regarding intellectual property and inventions.
Record of Invention Form	A form to disclose an invention to OTC.
Record of Copyright Form	A form to disclose a copyright to OTC.

Key Policies and Information

Resource	Description
FIN – 002.0 - Equipment Acquisition and Maintenance	To establish policies and procedures for the for the acquisition, maintenance, and control of CHLA equipment at the hospital, which provides appropriate accountability, controls, cost containment and flexibility in support of CHLA’s mission.
FIN – 005.0 - Petty Cash	Governs disbursement and management of petty cash, which may be used for subject stipend or visit payments.
FIN – 043.0 – Cost Sharing/Cost Matching Policy	The policy of the hospital is to make a cost sharing commitment only when required by the sponsor or by the competitive nature of the award and then to cost share only to the extent necessary to meet the specific requirements of the sponsored project.
FIN -010.0 Procurement	To establish policies and procedures for the procurement function at Children’s Hospital Los Angeles (CHLA), which provides appropriate accountability, controls, cost containment and flexibility in support of CHLA’s mission.
FIN – 044.0 – Cost Transfer Policy	The purpose of this policy is to prescribe the conditions under which expense transfers between cost centers and/or project numbers may be made.
FIN – 045.0 Time and Effort Certification	Children’s Hospital Los Angeles requires faculty/employees to certify the percentage of time (i.e., effort) that they devote to the federally funded grants and contracts
FIN – 046.0 - Research Grant Accounts	This policy explains the need to identify clinical research patients, delineate the routine costs versus research charges, and ensure that appropriate billing occurs.
FIN – 047.0 Residual Funds on Sponsored Awards	Describes the process for review and approval to move any project residual funds to a discretionary account for use.
FIN – 048.0 - Indirect Costs	Research Operations will ensure that all proposals submitted to any sponsoring agency include the appropriate indirect cost recovery rate.
FIN – 049.0 Research Agreements, Applications and Proposals for Extramural/Sponsored Project Funds	CHLA actively promotes research as one of its primary missions. The pursuit of external sources of funds to support research and other activities through sponsored projects is one of the most important efforts of the researchers and staff of the hospital.
FIN – 059.0 Sponsor Authorized Pre-Award Spending and Requests for Advanced Spending (RAS)	The purpose of this policy is to outline the circumstances and other administrative matters when a Principal Investigator/Project Director (“PI/PD”) needs to incur expenditures on an extramural grant prior to receiving the official notice of award.
ADM 142.0 - Intellectual Property Policy – For Invention and Copyright Disclosures prior to December 2, 2020	This policy is applicable prior to December 2, 2020. The purpose of the policy is to educate faculty, staff, students, and visitors about their rights and responsibilities regarding intellectual property and inventions.
EGEN – 013.0 New Intellectual Property Policy – For Invention and Copyright Disclosures after December 2, 2020	This policy is applicable after December 2, 2020. The purpose of the policy is to educate faculty, staff, students, and visitors about their rights and responsibilities regarding intellectual property and inventions.
COMP – 004.0 Authorization to Use or Disclose PHI	The purpose of this policy is to implement the requirements of the applicable state and federal laws governing the use and disclosure of Protected Health Information (PHI).
COMP – 007.0 – HIPAA Minimum Necessary	The purpose of this policy and procedure is to implement HIPAA provisions that require a covered entity to reasonably limit the use and disclosure of Protected Health Information (PHI) to the minimum necessary to accomplish a particular purpose.
COMP – 012.0 Research and Patient Privacy; De-identification and Limited Data Sets	This policy implements requirements of applicable state and federal privacy laws governing how the Protected Health Information (PHI) of patients and research subjects may be used or disclosed.
COMP – 019.0 Record Retention	Standards for the retention of records of CHLA. Refer to COMP 019.1 for the retention schedule.
COMP – 021.0 Conflicts of Interest in Research	For faculty, staff, and students to disclose their business and financial interests to encourage transparency so as to not conflict with the highest ethical standards for their employment and research at CHLA. Requests for information regarding significant financial interests for key or senior research investigators on Public Health Service (PHS) or National Institutes of Health (NIH) funded projects determined to be financial conflicts of interest (fCOI) may be directed to the Office of Compliance & Privacy at compliance@chla.usc.edu.
COMP – 022.0 - Institutional Conflicts of Interest in Research	This policy promotes the highest ethical standards in the conduct of Research in situations where Institutional Conflicts of Interest may occur, and to determine those instances when an Institutional Conflict of Interest is unacceptable.
COMP – 030.0 Compliance Training and Education	This Policy and Procedure implements state and federal mandates for training the CHLA workforce on CHLA privacy policies and procedures.
FIN – 032.0 - Signature Authority	Describes the appropriate signature authority for contracts, and designates Research Operations as appropriate signatory for research agreements.
PC – 006.0 Communication Assistance	The purpose of this policy is to establish the Children’s Hospital Los Angeles workplace policy is to assist in facilitating communication between patients/research subjects/families and care providers/researchers, especially those with limited English Proficiency (LEP) or suspected communication vulnerability.
MARCOM – 006.0 Interactions with News Media	This statement will serve as the standard and policy in providing information to the news media. In the release of any information, full consideration is first given to the best interest of the patient and their family, to the ethics of the medical profession and to other hospital policies.