Clinical Trials Physician Information

Information for Clinical Trials in the LSU Healthcare Network

This page will provide research teams with information on how to move trials quickly from initial proposal through contract execution.

Additionally, this page describes tools in Allscripts PM electronic health record for sponsored clinical trials at the LSU Healthcare Network Clinical Trials Office (CTO).  When research subjects are enrolled on a study that involves clinical services at the LSUHN (LSUHN), there are requirements within Allscripts to properly identify, schedule, charge for clinical services and document clinical study activities.

All research services utilizing LSUHN clinical services must have a research guarantor account set up in Allscripts done through the LSUHN CTO.

The purpose for this procedure is to facilitate quality clinical trial research and provide effective, efficient evaluation of new pharmaceuticals and medical devices. 

The CTO can assist principal investigators (PI) with trials funded by industry contracts. CTO start-up services include comprehensive budget development and coverage analysis, contract negotiation, regulatory guidance and budgeting/billing assistance.

The following initiatives are described below: confidentiality agreements, feasibility meetings to assess new protocols, budget preparation and contract negotiations. 

Before Getting Started

Before staff invest time and resources into initiating a new clinical trial, it is important to verify that the study is appropriate for the site. It is impractical to start a new project if the patient population does not exist or if there are not enough financial or personnel resources. The best way to avoid a failed study is to follow the outline set forth below. The following describes the process to appropriately screen studies by evaluating the feasibility of the protocol.

Confidentiality Agreements (CDA) Most industry sponsors consider their research protocol to be proprietary and will not share the information with a prospective investigator and site unless a confidentiality agreement is signed. Usually CDAs are straightforward; however, there are some potential pitfalls. For example, the agreement might be overly broad, going beyond the purpose of the protecting against disclosure of the sponsor’s protocol and other confidential information. Therefore, it is important to allow the LSUHN Legal to review the CDA before the investigator signs. The sponsor will usually request the institution to sign a CDA in which case the CEO of LSUHN signs. After the CDA is executed, the sponsor will provide the Principal Investigator (PI) the full protocol.

Feasibility Reviews 

Delays in research have significant time and cost implications and negatively impact departments and the organization. Clinical trial feasibility is one of the first steps in clinical trial conduct and the best means we have for decreasing the potential for delays and mitigating potential risks. Feasibility assessments include but are not limited to:

  • Investigator interest
  • Patient population to determine capacity and speed of enrollment
  • Possible confounding factors in patient recruitment
  • Successful patient recruitment techniques
  • Availability of qualified site personnel
  • Availability of equipment/facilities required to successfully conduct the trial
  • Cost of conducting the study

In order to perform the feasibility review, the sponsor will need to complete the Sponsor Protocol Information Form and provide electronic copies of the following to the CTO to perform the review:

  • Study protocol
  • Sponsor’s template clinical trial agreement
  • Sponsor’s budget proposal
  • Sponsor’s draft informed consent
  • Investigator Brochure and Pharmacy Manual, for investigational drugs
  • Instructions for Use, for devices
  • Lab Manual if using a central lab
  • Copy of case report forms
  • Copies of questionnaires, diaries, etc.

A Feasibility Decision Meeting is scheduled with all stakeholders involved in the proposed study to review the scientific, operational and fiscal considerations of the project to ensure an informed decision is made as to whether the investigator, department and institution are prepared to pursue the project. Additionally, the Feasibility Decision Meeting guarantees all critical players are involve in the final decision. Prior to the meeting, the Principal Investigator must complete the Clinical Trial Information Form and be prepared to give a preliminary overview of the study including a technical plan for how the project tasks will be accomplished. Also, the PI and the study team must be prepared to describe any ancillary services the project may require. The Clinical Trial Office will send out feasibility review packets to the proposed study team members identified on the Clinical Trial Information form and coordinate the meeting between the Principal Investigator and research team as well as all other ancillary services and offices that will be involved in the project. The completed review forms will be compiled and a determination of “Recommended” or “Not Recommended” will be made from the feasibility review.

Getting Started

Once the project has been recommended at the Feasibility Decision Meeting, the CTO can begin working on the different processes required to start a new clinical trial.

Estimated Timeline for Completion of CTO Services

Contracting: Clinical Trial Agreement

For every clinical trial performed at LSU Healthcare Network, there is a research agreement called the Clinical Trial Agreement (CTA) that is negotiated between LSU Healthcare Network and the sponsor, or the Contract Research Organization (CRO) representing the sponsor. The PI is asked to sign the agreement, indicating that he or she has read and understands his or her role and the terms. The CTA is a legal document and defines the important issues such as conduct of the study, publication, indemnification, confidentiality and data ownership. Typically sponsors prefer to use their own standard agreement to provide homogeneity for multi-site studies. If any of the language in the sponsor’s template is unacceptable, CTO will work directly with the sponsor to negotiate mutually acceptable language. The CTA will also include a budget and payment schedule. CTO will work with the study team to develop and negotiate a study budget and payment schedule. Once developed, the financial terms will be finalized with the sponsor by CTO. These negotiated terms are included in the final research agreement.

CTA Process

In order to reduce the start-up time for industry-sponsored clinical trials, CTO has implemented a process by which the language of the contract and financial terms can be negotiated concurrently with the submission of regulatory documents and IRB application. After approval from the feasibility review is obtained, CTO can start working with legal to negotiate the terms of the agreement with the sponsor.  LSUHN counsel must provide their final approval before language can be returned to the sponsor.

Budget and Billing Grid

The CTO will work directly with the PI and study team to ensure an appropriate budget is developed. The PI will need to identify all the procedures in the protocol as either standard of care or research related. A key point in making this decision is to recognize if the patient would have the service regardless if he or she is enrolled in the protocol. If the answer is no, then the sponsor must cover the expense of the service. CPT codes or services codes must be identified for each research related billable services, such as x-rays, laboratory tests or procedures. Once all CPT codes have been identified, the billing grid can be developed. The billing grid identifies all services to be charged to the research account. In addition to billable services, the budget must include salary support for coordinator or other support staff, overhead, pass through costs and invoiced items. Salary support is determined by estimating the number of hours each task will require, including time for data entry, query resolution, regulatory document maintenance, etc. All clinical trials must include a 35% overhead. Pass through cost are non-refundable fees due once the CTA has been executed. These costs might include:

  • Start-up costs (salary support for regulatory document & IRB submission, trainings, etc.)
  • Contract & budget negotiations

Invoiced items are services or items that can be invoiced only when they occur. Examples of items that might be invoiced are:

  • Serious Adverse Events
  • Audits
  • Advertising
Clinical Research Account Build in Allscripts PM

Allscripts must be customized with each new clinical trial initiated with billable clinical research services. The following is a description of the tasks to be completed.

  1. CTO will submit IT Helpdesk Ticket to create a new insurance policy for the study with the following information:

A. Abbreviation: IRB[number] B. Carrier Name: RESEARCH [PI Last Name] [Study Friendly Reference]                  Please note-The carrier name is limited to 30 characters including spaces. C. Contact Name: Billing Invoice contact/Name of Department D. Policy Number: IRB Number E. Group Number: NCT Number

  1. IT will create the new study insurance policy number in Allscripts. An autogenerated insurance policy number from Allscripts will be created.
  2. IT will send this autogenerated insurance policy number to the revenue cycle management company, ACS, with a copy to the CTO Director.
  3. ACS builds an account in their CompuMed System.
  4. All patients enrolled in a trial must be registered with the study insurance policy when scheduled for research-only visits. If a patient is scheduled for a mixed billing visit where routine care and research services will be performed, the patient’s primary insurance policy must be used during registration and allocating research services to the study insurance policy will be done on the back end by ACS.

BEFORE GETTING STARTED

Before staff invest time and resources into initiating a new clinical trial, it is important to verify that the study is appropriate for the site. It is impractical to start a new project if the patient population does not exist or if there are not enough financial or personnel resources. The best way to avoid a failed study is to follow the outline set forth below. The following describes the process to appropriately screen studies by evaluating the feasibility of the protocol.

Confidentiality Agreements (CDA) Most industry sponsors consider their research protocol to be proprietary and will not share the information with a prospective investigator and site unless a confidentiality agreement is signed. Usually CDAs are straightforward; however, there are some potential pitfalls. For example, the agreement might be overly broad, going beyond the purpose of the protecting against disclosure of the sponsor’s protocol and other confidential information. Therefore, it is important to allow the LSUHN Legal to review the CDA before the investigator signs. The sponsor will usually request the institution to sign a CDA in which case the CEO of LSUHN signs. After the CDA is executed, the sponsor will provide the Principal Investigator (PI) the full protocol.

Feasibility Reviews 

Delays in research have significant time and cost implications and negatively impact departments and the organization. Clinical trial feasibility is one of the first steps in clinical trial conduct and the best means we have for decreasing the potential for delays and mitigating potential risks. Feasibility assessments include but are not limited to:

  • Investigator interest
  • Patient population to determine capacity and speed of enrollment
  • Possible confounding factors in patient recruitment
  • Successful patient recruitment techniques
  • Availability of qualified site personnel
  • Availability of equipment/facilities required to successfully conduct the trial
  • Cost of conducting the study

In order to perform the feasibility review, the sponsor will need to complete the Sponsor Protocol Information Form and provide electronic copies of the following to the CTO to perform the review:

  • Study protocol
  • Sponsor’s template clinical trial agreement
  • Sponsor’s budget proposal
  • Sponsor’s draft informed consent
  • Investigator Brochure and Pharmacy Manual, for investigational drugs
  • Instructions for Use, for devices
  • Lab Manual if using a central lab
  • Copy of case report forms
  • Copies of questionnaires, diaries, etc.

A Feasibility Decision Meeting is scheduled with all stakeholders involved in the proposed study to review the scientific, operational and fiscal considerations of the project to ensure an informed decision is made as to whether the investigator, department and institution are prepared to pursue the project. Additionally, the Feasibility Decision Meeting guarantees all critical players are involve in the final decision. Prior to the meeting, the Principal Investigator must complete the Clinical Trial Information Form and be prepared to give a preliminary overview of the study including a technical plan for how the project tasks will be accomplished. Also, the PI and the study team must be prepared to describe any ancillary services the project may require. The Clinical Trial Office will send out feasibility review packets to the proposed study team members identified on the Clinical Trial Information form and coordinate the meeting between the Principal Investigator and research team as well as all other ancillary services and offices that will be involved in the project. The completed review forms will be compiled and a determination of “Recommended” or “Not Recommended” will be made from the feasibility review.

GETTING STARTED

Once the project has been recommended at the Feasibility Decision Meeting, the CTO can begin working on the different processes required to start a new clinical trial.

Estimated Timeline for Completion of CTO Services

CONTRACTING: CLINICAL TRIAL AGREEMENT

For every clinical trial performed at LSU Healthcare Network, there is a research agreement called the Clinical Trial Agreement (CTA) that is negotiated between LSU Healthcare Network and the sponsor, or the Contract Research Organization (CRO) representing the sponsor. The PI is asked to sign the agreement, indicating that he or she has read and understands his or her role and the terms. The CTA is a legal document and defines the important issues such as conduct of the study, publication, indemnification, confidentiality and data ownership. Typically sponsors prefer to use their own standard agreement to provide homogeneity for multi-site studies. If any of the language in the sponsor’s template is unacceptable, CTO will work directly with the sponsor to negotiate mutually acceptable language. The CTA will also include a budget and payment schedule. CTO will work with the study team to develop and negotiate a study budget and payment schedule. Once developed, the financial terms will be finalized with the sponsor by CTO. These negotiated terms are included in the final research agreement.

CTA Process

In order to reduce the start-up time for industry-sponsored clinical trials, CTO has implemented a process by which the language of the contract and financial terms can be negotiated concurrently with the submission of regulatory documents and IRB application. After approval from the feasibility review is obtained, CTO can start working with legal to negotiate the terms of the agreement with the sponsor.  LSUHN counsel must provide their final approval before language can be returned to the sponsor.

Budget and Billing Grid 

The CTO will work directly with the PI and study team to ensure an appropriate budget is developed. The PI will need to identify all the procedures in the protocol as either standard of care or research related. A key point in making this decision is to recognize if the patient would have the service regardless if he or she is enrolled in the protocol. If the answer is no, then the sponsor must cover the expense of the service. CPT codes or services codes must be identified for each research related billable services, such as x-rays, laboratory tests or procedures. Once all CPT codes have been identified, the billing grid can be developed. The billing grid identifies all services to be charged to the research account. In addition to billable services, the budget must include salary support for coordinator or other support staff, overhead, pass through costs and invoiced items. Salary support is determined by estimating the number of hours each task will require, including time for data entry, query resolution, regulatory document maintenance, etc. All clinical trials must include a 35% overhead. Pass through cost are non-refundable fees due once the CTA has been executed. These costs might include:

  • Start-up costs (salary support for regulatory document & IRB submission, trainings, etc.)
  • Contract & budget negotiations

Invoiced items are services or items that can be invoiced only when they occur. Examples of items that might be invoiced are:

  • Serious Adverse Events
  • Audits
  • Advertising

Clinical Research Account Build in Allscripts PM

Allscripts must be customized with each new clinical trial initiated with billable clinical research services. The following is a description of the tasks to be completed.

  1. CTO will submit IT Helpdesk Ticket to create a new insurance policy for the study with the following information:

A. Abbreviation: IRB[number] B. Carrier Name: RESEARCH [PI Last Name] [Study Friendly Reference]                  Please note-The carrier name is limited to 30 characters including spaces. C. Contact Name: Billing Invoice contact/Name of Department D. Policy Number: IRB Number E. Group Number: NCT Number

  1. IT will create the new study insurance policy number in Allscripts. An autogenerated insurance policy number from Allscripts will be created.
  2. IT will send this autogenerated insurance policy number to the revenue cycle management company, ACS, with a copy to the CTO Director.
  3. ACS builds an account in their CompuMed System.
  4. All patients enrolled in a trial must be registered with the study insurance policy when scheduled for research-only visits. If a patient is scheduled for a mixed billing visit where routine care and research services will be performed, the patient’s primary insurance policy must be used during registration and allocating research services to the study insurance policy will be done on the back end by ACS.