Research Sponsor Information


Contractual Requirements

Regulatory Requirements

Contractual Requirements

The Johns Hopkins School of Medicine abides by the following contractual requirements for sponsor-initiated clinical studies:

The sponsor of the clinical study must indemnify Johns Hopkins University, its employees, its agents, and its affiliated hospitals from any liability, loss, or damage resulting form the performance of a study.

The sponsor must reimburse Johns Hopkins University for any cost that is necessitated, as a direct result of participation in the study and that is not covered by the participant’s medical insurance.

View the School of Medicine’s Model Clinical Trial Agreement

View the School of Medicine’s list of Master Clinical Trial Agreements

For information on TDC rates, please refer to the Sponsored Projects Handbook, published by the School of Medicine’s Office of Research Administration.

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Regulatory Requirements

The Johns Hopkins University School of Medicine, The Johns Hopkins University School of Nursing, the Johns Hopkins Hospital, and the Kennedy Krieger Institute require that no research project involving human subjects be initiated until the project has been reviewed and approved, or declared exempt from review.

The Joint Committee on Clinical Investigation (JCCI) is the Institutional Review Board (IRB) charged with the responsibility for review and approval of human subjects research conducted by faculty members (full or part-time) of The Institutions, and all research involving patients and/or employees of The Johns Hopkins Hospital or The Kennedy Krieger Institute, and/or employees or students of the School of Medicine. Review is required regardless of source (or lack of source) of funding for a project and regardless of the site at which the research is performed. The JCCI operates in compliance with the U.S. Code of Federal Regulations, Department of Health and Human Services (DHHS) Title 45 Part 46, entitled "Protection of Human Subjects", as well as the Food and Drug Administration (FDA) regulations on human subjects research.

The JCCI has a useful and informative website:

Here you can find direct links to most JCCI forms. It's also a great resource to familiarize yourself with guidelines and operating procedures.

Some forms you might need for your IRB submission would be:

Research Project RPN application
Consists of a form and questionnaire

Consent form
Should be on pastel blue colored paper

Radiation forms
The radiation committee is so helpful. Call them!

Drug data form
Is it an IND study? Remember to submit a copy of the protocol and Investigator's brochure for studies of investigational drugs or devices.

A new application is called an RPN (Research Project Notification). If your study is an industry-initiated project, you are typically required to fill out the application form, obtain the sponsor's IND#, protocol, investigator's brochure, investigational new drug form and the radiation forms. Tip: To save time, submit the consent form for review by the sponsor at the same time that you submit to the IRB. You can always make changes later. If your study is NIH-funded, be sure to submit the Human Subjects Section of the grant along with the application, as well as a full copy of the grant.

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