Drexel University College of Medicine

This submission process only relates to clinical research that is sponsored or supported by a private entity.  For information relating to government-funded research, please visit the Drexel University Office of Research Compliance and Administration website.

If you are a new or existing member of the College of Medicine's clinical research community, this page provides a general outline of the process to start a study in the most common chronological order.  In most clinical research sponsored by industry companies, the College of Medicine will serve as one site out of many sites conducting the study.  In order to ensure that all research sites are conducting the study in a uniform manner, each sponsor will have specific procedures that you will be required to meet.  Thus, the order of activities and requirement outlined below may differ slightly for each research study.

PRE-START UP CLINICAL RESEARCH ACTIVITY

A.  Initial Questionnaire and Site Survey
B.  Confidentiality Agreement:  Obtaining the Protocol and Other Research Documents
C.  Assessing Study Feasibility

START-UP CLINICAL RESEARCH ACTIVITY

A.  Regulatory Compliance
B.  Clinical Trial Agreement
     1.  Negotiating the Clinical Trial Agreements
     2.  Negotiating the Clinical Trial Budget
     3.  Executing the Clinical Trial Agreement

PRE-START UP CLINICAL RESEARCH ACTIVITY

A.  Initial Questionnaire and Site 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. If any questions relate to legal, contract, budget and/or financial issues, the CRG can assist in completing the questionnaire.  For assistance, please contact Stephanie Peterson.  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 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 the College 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 are kept confidential and 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). 

Once the terms of the CDA have been finalized, the CDA will be executed.  The CRG office will arrange the CDAs to be executed by an authorized representative. 

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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. 

If it is decided that the College will not serve as a site, the CRG should be notified. Based on the terms of the CDA, sponsor may require the College to return or destroy the protocol and other study materials.  

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 are reviewed by Western Institutional Review Board (WIRB). However, the Office of Regulatory Research Compliance (ORRC) manages and oversees this process. Thus, all submissions for WIRB review must be made to the ORRC. 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 ORRC website, click here.

Note that the sponsor is responsible for any fees associated with IRB review and approval (including continuing reviews).  Provided written approval is obtained, a study can be submtted for IRB review and approval prior to executing the CTA.  Written approval by the sponsor is necessary to ensure that the sponsor has agreed to pay for such IRB fees even if the study is not initiated by the College.  Also note that even if IRB approval is attained, the IRB will not release study documents until the CTA is executed. 

Patient Injury Compensation:  For studies in which the sponsor will not reimburse for patient injury, the ORRC must be notified prior to submission.  Any industry sponsored study that does not provide reimbursement for patient injury must be pre-approved by the ORRC prior to submitting to WIRB.  Once WIRB receives the pre-approved submission, it will verify ORRC's approval.  If WIRB does not receive such approval from ORRC, it will automatically amend the proposed informed consent to provide reimbursement for patient injury. 

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B.  Clinical Trial Agreement (CTA)

 1.  Negotiating the Clinical Trial Agreements (CTAs)

The Clinical Trial Agreement (CTA) is an agreement between a sponsor and Drexel University College of Medicine to establish the terms and conditions in which the College will conduct the study. Notable terms established in most CTAs are compliance, access to information, intellectual property, publication rights, compensations (budget), confidentiality and privacy, and publicity.  

CTAs can appear in many different forms. CTAs are also known as “Research Agreements” or “Clinical Research 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 at  stephanie.peterson@drexelmed.edu . 

All CTAs must be submitted to the CRG for contract and budget review. To request review of a sponsor’s CTA, please click on the appropriate e-mail form on the right hand column.  

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   2.  Negotiating the Clinical Trial Budget

For any clinical research study, the principal investigator must ensure that s/he has the appropriate funding to support the research activity.  The study budget is contained in the CTA and must be negotiated along with the CTA.  The CRG has appointed a budget analyst for each clinical department within the College.  Once the principal investigator or study coordinatorrequest the CTA (and budget), the designated CRG budget analyst will analyze and negotiate the budget.  Analyzing the budget requires review and assessment of the research protocol, the College's and Tenet's pricing schedules, as well as the effort required by the principal investigator and study coordinator to conduct the research.  After the budget analyst confirms an appropriate budget with the principal investigator and study coordinator, the analyst starts negotiations with the sponsor or company providing support  the research.  Once the budget analyst and the sponsor agree upon the budget, it is attached to the finalized CTA, which is then signed by both parties.

To learn more about this process, please visit the CRG budget webpage (click here).   

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   3.  Executing the Clinical Trial Agreement

As stated in the Legal Notice above, the finalized CTA (which contains the final budget) is executed by both the College and the sponsor.  Once the CTA is fully executed, the CRG will notify the Office of Regulatory Research Compliance, who will arrange the release of IRB-approved documents.

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