PRE-START UP CLINICAL RESEARCH ACTIVITY
A. Initial Site Questionnaire and Survey
Sponsors will usually contact the department either by phone, e-mail, fax or in person regarding potential clinical trials. If the principal investigator is interested in participating in a clinical trial, the sponsor should be contacted to express the College’s interest in the clinical trial. The sponsor will provide a site questionnaire it will use to evaluate the College as a site for the particular clinical trial. Once the questionnaire is completed, it must be reviewed by the principal investigator before it is returned to the sponsor.
The sponsor may also visit the College to conduct an initial site survey as part of the evaluation. The study coordinator and the principal investigator must be present for the initial site survey visit. The sponsor will want to tour laboratories and other support service areas which will be used to potentially conduct the clinical trial. The study coordinator will provide the sponsor with a tour of the College and the relevant clinical facilities. If hospital facilities are to be used for the study, then those areas should also be toured. Be sure to contact the appropriate the College and hospital personnel to make arrangements for the tour. The study coordinator should remain with the sponsor representative for the entire survey. The tour and discussions should only be limited to the College and Tenet facilities and staff. Other research studies or projects should not be discussed during the tour.
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B. Confidentiality Agreement: Obtaining the Protocol and Other Research Documents
Before providing a protocol and other research documents regarding the clinical trial, the sponsor may require Drexel University College of Medicine to enter into a confidentiality disclosure agreement (CDA). A CDA is an agreement between a sponsor and the College to ensure that any research documents will only be used to evaluate the clinical trial. All CDA’s must be reviewed and approved by the CRG. CDA’s are also known as “Secrecy Agreements” or “Nondisclosure Agreements.” CDAs can also appear in many different ways such as in a letter form or even as an item in the initial site questionnaire. The only way to identify a CDA is to read and interpret the words. All CDAs must be submitted to the CRG for review. If you have any questions regarding whether a certain document is a CDA, contact Stephanie Peterson (stephanie.peterson@drexelmed.edu). trial as well as the name of the study compound, drug or device.
Legal Notice: Under university policy, only designated representatives are authorized to sign agreements (such as CDAs) on behalf of Drexel University College of Medicine. Principal Investigators and other staff are not authorized to sign research agreements (such as CDAs) on behalf of the College. If a Principal Investigator or other staff signs such an agreement, s/he will incur sole responsibility and the University will be unable to provide legal support in the event that the terms of the Agreement are breached. In addition, the Principal Investigator should never be the named party to the CDA or any other research agreement relating to the clinical trial without university approval. The university should be the named party in the agreement. Drexel University College of Medicine’s legal name is: Philadelphia Health & Education Corporation d/b/a Drexel University College of Medicine.
DrexelMed Template CDA: To facilitate the CDA review process, the College of Medicine has a template agreement that can be executed immediately without review by the CRG. To view and prepare the College’s template CDA, click here.
The template must be prepared “as is” using the instructions found on the page preceding the template agreement. Any changes to the template will require CRG review. Such a review usually takes a shorter period of time than review of a sponsor’s CDA template. Sponsors may contact Stephanie Peterson (stephanie.peterson@drexelmed.edu) to request an editable electronic version of the template agreement.
Sponsor Template CDA: If a sponsor requires the use of its own template CDA, CRG review is required. To request review of the sponsor’s CDA template, please click on the button below.
Please be sure to Include the following information and documentation in the e-mail:
- Name of Principal Investigator
- Department
- Department Code (if available)
- Name of Clinical Research Coordinator
- Name of Sponsor
- Name of CRO (if applicable)
- Sponsor Contact for Contract Review (e-mail, phone number, mailing address)
- Title of Study
- Protocol No.
- Study Drug/Device (if Title of Study not available)
- CDA (Electronic copy of contract in MS Word format)
Once the terms of the CDA have been finalized, the CRG office will have two (2) original copies executed. If necessary, the CRG will forward both copies to the principal investigator for signature. Once the CDA is executed by the College, the CRG will forward both copied to the sponsor for signature. The sponsor will then return one of the fully signed original copies to the CRG. The sponsor will then provide the protocol and other research documents for review. Click here.
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C. Assessing Study Feasibility
The Principal Investigator and Study Coordinator will review the protocol and other research documents provided by the sponsor and assess the feasibility of Drexel University College of Medicine as a site for the clinical trial. Based on the initial site survey and questionnaire and review of the protocol and other documentation, the principal investigator and the sponsor will then decide whether the College shall serve as a site to the clinical trial.
The principal investigator and study coordinator will review the protocol and other research documents provided by
If it is decided that the College will not serve as a site, notify the CRG. Based on the terms of the CDA, you may be required to return or destroy all materials provided by the sponsor.
If it is decided that the College will serve as a site, the below “Start-Up” process should be completed.
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START-UP CLINICAL RESEARCH ACTIVITY
A. Regulatory Compliance
Any research involving human subjects must be reviewed and approved by an Institutional Review Board (IRB). All industry-sponsored clinical trials conducted at Drexel University College of Medicine will be reviewed by Western Institutional Review Board (WIRB). However, the Office of Research Compliance (ORC) manages and oversees this process. Thus, all submissions for WIRB review must be made to the ORC. No submissions (full reviews, continuing reviews, amendments and adverse events) shall be made directly to WIRB. Information and guidance on how to submit your clinical research to WIRB can be found on the ORC website, click here.
Patient Injury Compensation: For studies in which the sponsor will not reimburse for patient injury, ORC must be notified prior to submission. Any industry sponsored study that does not provide reimbursement for patient injury must be pre-approved by the ORC prior to submitting to WIRB. Once WIRB receives the pre-approved submission, it will verify ORC's approval. If WIRB does not receive such approval from ORC, it will automatically amend the proposed informed consent to provide reimbursement for patient injury.
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B. Clinical Trial Agreement or Other Clinical Research Agreement
1. Negotiating and Executing Clinical Trial Agreement
The Clinical Trial Agreement is an agreement between a sponsor and Drexel University College of Medicine to establish the terms and conditions in which the College will serve as a research site for a particular study. Notable terms established in most CTAs are intellectual property and publication rights, compensations (budget), confidentiality and indemnification obligations, publicity, and access to information.
CTAs can appear in many different forms. CTAs are also known as “Research Agreements” or “Clinical Service Agreements.” CTAs can also appear in many different ways such as in letter form, statement of work, or even as a section in a form. Just like a CDA, the only way to identify a CTA is to read and interpret the text. If you have any questions regarding whether a certain document is a CTA, contact Stephanie Peterson ( stephanie.peterson@drexelmed.edu ). All CTAs must be submitted to the CRG for contract and budget review.
Legal Notice: Under university policy, only designated representatives are authorized to sign agreements (such as CTAs) on behalf of the College. Principal Investigators and other staff are not authorized to sign research agreements (such as CTAs) on behalf of the College. If a Principal Investigator signs such an agreement, the Principal Investigator will incur sole responsibility and the University will be unable to support him/her in the event that the terms of the Agreement are breached. In addition, the Principal Investigator should never be the named party to the CTA or any other research agreement relating to the clinical trial without university approval. The university should be the named party in the agreement. Drexel University College of Medicine’s legal name is: Philadelphia Health & Education Corporation d/b/a Drexel University College of Medicine.
Requesting CRG Review of the CTA and Budget: To request review of a sponsor’s CTA, please e-mail Stephanie Peterson ( stephanie.peterson@drexelmed.edu ) or click on the below button
Please include the following information and documentation in the e-mail:
- Name of Principal Investigator
- Department
- Department Code (if available)
- Name of Clinical Research Coordinator
- Name of Sponsor
- Name of CRO (if applicable)
- Date of IRB Submission / Expected Date of IRB Submission
- Sponsor Contact for Contract Review (e-mail, phone number, mailing address)
- Sponsor Contact for Budget Review (e-mail, phone number, mailing address)
- Title of Study
- Protocol No.
- Study Drug/Device (if Title of Study not available)
- Will the study take place in any facilities owned by Tenet?
- Will Tenet services or personnel be used in any way?
Please include the following required documents:
- Protocol (Electronic copy of protocol)
- Contract (Electronic copy of contract in MS Word format)
- Budget (Electronic copy in MS Word or Excel)
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2. Master Clinical Trial Agreement
A Master Clinical Trial Agreement is an agreement between a sponsor and the College in which both parties agree upon a set of common terms and conditions for future designated research. These terms and conditions are normally covered in research agreements such as publication, confidentiality, intellectual property, indemnification, publicity, notice and access to information. These terms and conditions will govern future studies that are designated by the parties. The establishment of a Master Agreement cuts down on contract negotiations and ensures consistency in the College’s relationship with a sponsor. A Master Clinical Trial Agreement usually only covers Phase I, Phase II, and Phase III studies. It does not cover investigator-initiated research.
Once the Master Agreement is established, the College may use an "addendum" to add a new study to the Master Agreement. The addendum contain the terms and conditions that are specific to a study such as the protocol number and title of the study, the principal investigator, and budget terms. Each Addendum is "attached" to the Master Agreement and becomes part of the agreement.
Drexel University College of Medicine will work with sponsors to negotiate and establish a master agreement. Sponsors interested in establishing a master agreement with the College should contact the CRG office at 215-255-7805 or e-mail Stephanie Peterson at stephanie.peterson@drexelmed.edu .
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3. Amendments
Once a CTA is fully executed, it may be necessary to change the terms of the CTA or the budget. The following are examples of events that may require the College and Sponsor to execute an amendment to the CTA and/or budget.
Change in Principal Investigator
Change in the design of the study
Any changes to the budget
Change in enrollment expectations
Adding / Removing procedures
Any additional requirements that require substantial additional resources (e.g. personnel/administrative time).
If you have any questions regarding whether an amendment is necessary, contact Stephanie Peterson ( stephanie.peterson@drexelmed.edu ).
Requesting CRG Review of the CTA and Budget: To request review of a sponsor’s amendment, please e-mail Stephanie Peterson ( stephanie.peterson@drexelmed.edu ) or click the below button
Please include the following information and documentation in the e-mail:
- Name of Principal Investigator
- Name of Clinical Research Coordinator
- University Id. No.
- Name of Sponsor
- Sponsor Contact for Amendment Review (e-mail, phone number, mailing address)
- Title of Study
- Protocol No.
- Copy of Amendment (Electronic copy of contract in MS Word format)
C. Assessing the Budget
An adequate budget accurately assesses a research site’s financial needs for conducting a clinical study. In setting a budget for a study, sponsors will either set a certain amount per study patient or request that a research site develop a budget. It is very important to ensure that the budget amount agreed upon will adequately cover all costs associated with conducting the clinical trial. Since study protocols are unique from one another, assessing and calculating the costs for each protocol requires a comprehensive understanding of the financial aspects of patient care. In addition, an understanding of the College and its relationship with its affiliated hospitals is key in determining a budget. The College has appointed personnel in the CRG who assess and negotiate all budgets for industry-sponsored or investigator-initiated clinical trials. Principal investigators, study coordinators or other research staff should not assess and negotiate a budget without direction from the CRG.
As indicated above (see "Requesting CRG Review of the CTA and Budget"), an electronic version of the sponsor’s proposed budget must be emailed along with a copy of the contract and protocol to the CRG for review. The contract facilitator will forward the proposed budget and protocol to the financial coordinator for initial evaluation of your budget.
1. Required Costs
a. Facilities & Administrative (F&A) Costs
Under Drexel University College of Medicine policy, all clinical trials are subject to a standard Facilities & Administrative (F&A) cost rate (i.e., indirect cost rate, overhead, etc.). For fiscal year 2008, this rate is 30.0%. F&A costs cannot be waived. The College cannot assume the cost of performing research for a for-profit corporation. This would be inconsistent with its status as a non-profit, educational institution.
All fees (except the IRB fee) must include F&A costs. This includes Administrative Study Start-Up Fees (See below) and all invoiced costs such as MRI's, EKG's, advertising, etc. For example, if a sponsor reimburses $100.00 for an EKG required by the protocol, $76.92 will be available to pay the cost of the EKG (i.e., divide $100.00 by 1.30). The $76.92 takes into consideration the $23.08 F&A cost.
b. Administrative Study Start-up Fee
The Administrative Study Start-Up Fee is a one-time, nonrefundable fee to be paid within thirty (30) days of either execution of the CTA or upon receipt of the first invoice. The amount of this fee will vary depending upon the type of trial. The administrative start-up fee covers a combination of costs including but not limited to protocol review, IRB presentation, site selection visit, initiation visit, IRB application preparation and submission, chart review, database review, study-specific training, contract negotiation time, budget negotiation time, regulatory review, informed consent form review and preparation, etc.
c. Internal Review Board (IRB) Fee
Under Drexel University College of Medicine policy, all industry-sponsored clinical trials must be submitted to WIRB. WIRB’s fees cover the initial application, amendments, renewals, SAE reporting, etc. The WIRB fees are not subject to F&A costs. To simplify the payment process, WIRB will directly invoice a sponsor for all fees.
d. Storage Fees
It is the policy of Drexel University College of Medicine to negotiate a storage fee. This fee is a one-time, nonrefundable fee paid within thirty (30) days of either the close-out visit or upon receipt of an invoice. The amount of this fee will vary depending upon the type of trial. However, the standard minimum fee is $500.00.
e. Hospital Pharmacy Fee
In some studies, the hospital’s pharmacy must be used for the storage and dispensing of the investigational drugs. The hospital pharmacy fees vary depending upon the nature of the clinical trial. It is expected that the pharmacy fees will be included in your budget. The pharmacy fees must be obtained by providing the hospital pharmacist a copy of the most up-to-date protocol. The hospital pharmacist will then provide a pharmacy budget including the one-time and per-patient fees. It is important to understand the fee structure especially when reviewing the pharmacy’s invoice for payment processing.
f. Other Affiliate Hospital Costs
A number of costs are incurred by utilizing the hospital’s services including but not limited to radiology, cardiology and laboratory tests. The financial coordinator works with the sponsor by applying these costs to the proposed budget.
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2. Evaluating Time and Effort in Conducting the Clinical Trial
Most trials require costs and efforts that are often overlooked. Such costs include administrative costs such as copying of documents, telephone calls, mailing, cost of office supplies, storage, and equipment. The cost of the Principal Investigator, Study Coordinator or other research staff’s time should also be considered. The budget and protocol will provide a schedule of events listed by tasks as well as deadlines. Estimation of the cost per hour to conduct each clinical as well as administrative task.
The following are examples of common tasks commonly included in a clinical trial:
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Recruiting and advertising
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Screening
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Review of records
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Consenting patients
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Explaining or giving directions to a subject
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Answering questions by subject
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All procedures required by the protocol
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Taking a subject’s history
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Concomitant medications
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Conducting physical examinations
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Explaining the activities of the protocol
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Setting up and dispensing study drug
The following are examples of tasks that are administrative in nature that are required in most clinical trials:
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Maintaining research records
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Completing case report forms or other forms required in the protocol
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Communicating with the sponsor via telephone or in person during monitor visits
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Sending documents or records via e-mail, fax, or mail
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Answering queries
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Reporting adverse events
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