Drexel University College of Medicine

Legal Notice Under Drexel University College of Medicine policy, only designated representatives are authorized to sign agreements (such as CDAs and CTAs).  Principal Investigators and other staff are not authorized  to sign research agreements (such as CDAs and CTAs) on behalf of the College.  If a Principal Investigator or other staff signs such an agreement, s/he will incur sole responsibility and the College 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 College approval.

Confidentiality Agreements

 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. 

Clinical Trial Agreements

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 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 at  stephanie.peterson@drexelmed.edu . 

 Master Clinical Trial Agreements

The Master Clinical Trial Agreement is a CTA that applies to a group of clinical research studies sponsored by the same company.  In order to reduce negotiation time as well as streamline the terms and conditions between a sponsor and a research site (such as the College), some companies will prefer enting into a Master CTAs with the site.  The College of Medicine currently holds Master CTAs with the below companies. 

It is important that principal investigators and research staff conducting clinical research with any of the below companies, review the terms and conditions of the associated Master CTA.  Please request a copy from Stephanie Peterson at stephanie.peterson@drexelmed.edu. 

 While the Master CTA reduces the time to negotiate the contractual terms, note that the budget for each study must still be negotiated.