Study Start-Up FAQ’s

Resources for Starting a Clinical Study

I received a Confidentiality Disclosure Agreement or a non-disclosure agreement. What do I do? How do I get it approved?

A Confidentiality Agreement (also referred to as an "CDA", "NDA" or "Nondisclosure Agreement") protects a party's proprietary or non-public information, and is typically used when parties must disclose such information in order to evaluate a possible relationship with the other party. Completion of a CDA (or NDA) is usually the first step in evaluating initiation of a clinical trial. Generally, if the Rutgers investigator expects to disclose to or receive any confidential information from the outside entity, then the Confidentiality Agreement should be set up between Rutgers and the other party. Please note, Rutgers investigators are not authorized to sign on behalf of Rutgers.

All CDAs are to be forwarded to Legal Management.   Legal will review the CDA and route for signatures.  If you have questions regarding a CDA, please call the Legal Department at (732) 235-8700.

Document Submission Form:

 

 

___________________________________________________________________________

I have a signed CDA and have received a copy of the protocol. What next?

There are four major components to complete and have approved to start a study. These four areas should be done concurrently.

I. Protocol
II. Budget
III. Contract
IV. UMDNJ Forms

Other items of importance, including invoicing and sample close-out list.

_____________________________________________________________________________________

I. Protocol

The protocol can be submitted for review simultaneously with the contract/budget. Western IRB (WIRB), an independent commercial IRB located in Olympia, WA, has been contracted to act as UMDNJ's IRBs to review, approve and monitor industry-sponsored human subjects research.

All submissions to WIRB must go through the RBHS Human Subjects Protection Program.

Submittal Criteria and submittal checklist for the WIRB
Policies and Guidance for the WIRB
WIRB Guide For Researchers (2009)                                                                                               

Part of the protocol you received may include an Informed Consent. To ensure the Informed Consent you received (or need to write) is appropriate, clear and within regulation you may review  the Informed Consent webpage at UMDNJ's Human Subjects Protection Program (HSPP) Institutional Review Boards (IRBs).

Updated regulations require that for any study that is a clinical trial registered on Clinical Trials.gov the following language must be inserted into the Informed Consent no later than March 1, 2012. This language must be provided verbatim in the section addressing privacy and confidentiality :

"A description of this clinical trial will be available on ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this website at any time."

This language and more regarding Informed Consent can be found at RBHS' HSPP

                               top of page

Return to Top of Page___________________________________________________________________

II Budget/Project Feasibility

The Principal Investigator is responsible to ensure that the amount agreed upon will adequately cover all costs associated with conducting a clinical trial. Sponsors have been known to use many options when presenting a budget. Three potential options sponsors use when presenting a budget are: 1) they may offer a certain amount per patient and ask that you work within that amount or 2) they may present a budget or 3) ask you to formulate a budget.

• Sponsors may provide a budget, but,
• Sponsor's budget may not identify all of the cost of the trial at our institution, or
• Sponsor's budget may not reflect charges or annual inflation increase at our institution.

You should determine the feasibility of the study by gathering your potential costs and revenues. Each school has their own separate research office to review budgets and relevant documents. Your schools’ office may be able to help you conduct the feasibility or have specific budget requirements.

Here are some helpful hints and tips for preparing a feasibility of costs/revenues.

Costs
1) Need to identify relevant costs of the study. Some questions to ask are: is it inpatient and outpatient care? Do you need the services of the Clinical Research Center at your School? Will you be using a provider, such as laboratory outside of the University? Will you be paying for records retention during or after the study? Do you charge for screening failures? What will be paid for subjects, such as incentives, parking, travel?

2) Indirect Rate 30% is applied to all direct costs associated with clinical trials.

It is the policy of the University to charge industry sponsors for all direct and indirect costs incurred in the conduct of industry-supported clinical trials. All potential sponsors of clinical trial programs must be informed of this policy before beginning negotiation of research project budgets that will be included in the research contract.

To calculate indirect cost when the direct costs are known, add 30% of the direct costs. The sum of these two figures is the per-patient amount. Example: If $1,000 is needed to cover per-patient direct costs, 30% ($300) should be added for indirect, bringing the total to $1,300 per patient. The indirect cost rate is NOT applied to the institutional IRB review fee and any applicable pass through fees, such as advertising expenses

Revenues

1) Is there revenue outside of trial sponsor revenue? Can we bill private health insurance or Medicare for health care provided during research?

Because many third party payers follow Medicare's rules and regulations for covering standard or routine care associated with a clinical trial, it is important to understand or find someone who understands the Medicare guidelines on covering patient care during clinical trials. Costs of research are not reimbursable by Medicare and other third party payers. Patient-care costs for study subjects incurred for research purposes, over and above usual patient care, must be billed to the account associated with the investigational protocol for which study subjects have volunteered. However,  where research is conducted in conjunction with or as a part of the care of patients, the costs of usual patient care may be reimbursed by third party payers or Medicare to the extent such costs are not covered in the investigational study budget. Usual patient care is the care which is medically reasonable, necessary, and ordinarily furnished (absent any research programs) in the treatment of patients by providers under the supervision of physicians as indicated by the medical condition of the patients. However, Medicare will cover routine care costs of a clinical trial only if the trial "qualifies" under Medicare.

2) How does a trial get third party payment? Does this trial qualify for Medicare?

To answer these questions, a Medicare Coverage Analysis (MCA) should be done. The primary objective of the coverage analysis is to ensure that all costs of a clinical trial are billed to the appropriate payer whether it is the sponsor, a third-party payer, or the patient. Properly performed MCAs are also necessary to protect the researchers and institution against violations of the False Claims Act and other regulations.

The Centers for Medicare & Medicaid Services (CMS) National Coverage Decision for Routine Costs in Clinical Trials only allows for coverage of routine costs during a qualifying clinical trial. A coverage analysis will not only help you determine how to bill for your research, but will also enable you do determine if your clinical trial qualifies for third party coverage. If you need help conducting one, please contact your school's research office. Here is a link to a NJMS presentation regarding MCA and how to determine if your trial will qualify for Medicare. Note, since 1999, the state of NJ has a consensus agreement with private, NJ health insurance companies, including those affiliated with the New Jersey Association of Health Plans, to pay for the cost of the standard of care in covered cancer clinical trials. New Jersey Cancer Trial Connect has further information on this topic.

3) How do I estimate how much revenue the trial will provide? How do I know what is billed to research and what is billed to another party?

Create a document with a grid outlining what procedures or actions are to be performed during the trial and if that action will be paid for by research vs medicare vs other private, third party insurance. A sample grid is found here from NJMS. This form is also called a Budgeted Schedule of Events (BSOE), which is a tool that combines a calendar of events, items & services and costs to establish a budgeted billing plan. The BSOE delineates pure research from routine care in clinical research, which is vital to compliant clinical research billing. Contact your school, which may have a template already created.

Revenue Issues:
The sponsor negotiates the rate they will reimburse the researcher for each patient in the study. This rate is often governed by industry norms rather than actual costs of doing the research. In addition, the actual number of dollars received from the sponsor may vary greatly from the proposed amount because the number of participants recruited for the study could vary from the estimated number. There are many ways a sponsor could propose to pay for the study. Examples include payment

• on a per-patient basis with provisions for pro-rated payment for patients who do not complete the study, or
• at achievement at enrollment benchmarks.

Some practices are detrimental to or inappropriate for the University, such as bonus payments at a pre-specified level or payment only if a specified number of patients are recruited.

Tips on Collecting Revenue:
• Set enrollment targets as part of the budget negotiations, but also negotiate payment terms that will cover your incurred costs whether or not you meet the target.
• Avoid holdback clauses in any agreements if possible. They make payment reconciliation extremely difficult.
• Ideally payments should be made on a monthly basis if at all possible. The more you can standardize payment methods and schedules across sponsors, the easier it will be to follow-up, track, and reconcile payments from industry.
• If monthly payments are not possible, quarterly would be the second preference, with purely milestone based being the third preference unless the milestone based allow for more timely collection in a particular study.
• The contract should state that the sponsor must provide payment detail with each payment to facilitate reconciliation.
                                                                                                                                                                                       top of page                                        

Return to Top of Page     

_____________________________________________________________________________________

III The Clinical Trial Contract/Agreement

If  you are given a contract by a sponsor, contact your school’s research office or Legal Management at (732) 235-8700 to review this contract.  The Clinical Trial Agreement is reviewed and approved by Legal Management and signed by the designated Research Dean at the appropriate school.  Prinicpal Investigators can not execute an agreement on behalf of Rutgers.

Click here to submit CDA, CTA or other agreement to Legal Management.

Some Key Points Subjects of a contract include:

• Liability/payment for adverse events
• Material Transfer Agreements
• Publication vs Publication Restrictions:
• Intellectual property
• Confidentiality/Proprietary Information
• Indemnification
• Insurance
• Private Health Information                                                                                                                                                                                                                                                         top of page

Return to Top of Page                                                                                   ___________________________________________________________________________

IV Forms to Complete

The Endorsement Form

This form is the internal mechanism utilized to obtain the necessary research project information in order to process a proposal to a sponsor.  In the case of clinical trials, the completed and signed Endorsement Form is requested 10 business days prior to sponsor deadline date for any proposal for sponsored funding. The Office of Research and Sponsored Programs fully explains the Endorsement Form for Clinical Trials (a link to the PDF form is here) and the Endorsement Form for other types of clinical and non-clinical research.

Other Forms

Visit the Office of Research and Sponsored Programs for a full explanation of the other forms which may be required.                                                                                                                                                                 top of page 

 

Return to Top of Page                                                                                                                                               ___________________________________________________________________________________

Other Items of Importance to Know

Study Close-Out

There are many reasons why a study may close, including the list below:

Potential reasons for closure:
         The study has successfully completed.
         Enrolment goals cannot be met.
         The drug has proven to be unsafe (safety reasons).
         The drug has proven to be so effective that continuing is not necessary.
         The investigator has died and there is no replacement.
         Repeated fraud and misconduct, etc.

Things to consider when closing a study include the final monitor visit, notifying sponsor, notifying IRB, accounting for remaining investigational product, accounting for final costs and incoming revenue, document verifying study closure, and document archiving.  A sample checklist is availalbe here.

Invoicing Sponsor

Checks shall be made payable to "Rutgers, The State Univerity of New Jersey", and sent to:

Rutgers, The State University of New Jersey

RBHS-Division of Grant & Contract Accounting

65 Davidson Rd. Room 306

Piscataway, NJ 08854-5602

For identification purposes, each payment shall include the Principal Investigator’s name and the invoice number as referenced on the invoice. The New Tax ID/EIN# for RBHS is 46-2354111

 

 

Copyright ©2013, Rutgers, The State University of New Jersey, an equal opportunity, affirmative action institution.