Drug Trial Agreement

Drug Trial Agreement

This drug-trial agreement form outlines the intentions of DSI (Drug Study Institute) to act as an SMO (Site Management Organization) with you for the purpose of working together performing Investigational New Drug Trials to help Sponsors (Drug Companies) get their experimental Investigational New Drugs (IND) on the market faster.
We will offer you an opportunity from time to time to get involved with us on a particular IND. Of course you are never under any obligation to participate. However, if you decide to participate on a particular IND, you will be expected to follow a set of research rules to make sure that your patient, who has now become a research subject volunteer, has his rights and safety preserved, and that the Sponsors' research protocol is followed. If for any reason you deviate from the protocol, everyone must be informed right away including: DSI, the Sponsor, the CRO (Contract Research Organization: helps sponsor administer the IND) and the IRB (Institutional Review Board: assures human subject volunteer safety and preserves their rights).
Our goal is to enable you to conduct INDs in your office as a sub-investigator affiliated with DSI. You will identify one of your patients as a potential research subject volunteer. You will go over the Inclusion/Exclusion Criteria to make sure he/she is eligible. You will then briefly discuss the research protocol with the subject. If they seem interested, you can either take out the ICF (Informed Consent Form) and read it over with the patient and provide them with proper IC (Informed Consent) and/or call us and one of our CRC's (Clinical Research Coordinators) will come and provide the patient with proper IC and have you then go over it with your patient. Our CRC will bring the study drug to your site (office) and copy some of your source documents (charts) to make a shadow chart to bring to DSI, where we will "work" the chart. That is, we will fill out the CRFs (Case Report Forms) and respond to the sponsors' Queries/DCFs (Data Clarification Forms). Periodically, the sponsor will send a monitor/CRA (Clinical Research Associate) to review the progress of the study. Our CRC will go over the shadow charts in our office and bring the monitor to your site to see your original source documents and to meet with you to determine if you have been conducting the research according to GCP-ICH Guidelines (see footnotes below).
Your patient will never need to come to DSI; you will conduct the whole study with our CRC's help at your own office. You will see how rewarding it is to spend more time with your patients, actively asking them if they had any (S)As (Serious) Adverse Events, providing them with free medical care and medications, and actually paying them and thanking them for coming in and volunteering.
It is my intention to set up a "Research Consortium Network"/SMO that will be comprised of Doctors doing quality, reliable, ethical reserach that will provide their patients with a higher standard of care without the current financial burdens of modern medical care in a relaxed attentive atmosphere.
This non-exclusive agreement states that should you choose to participate as a Sub-I (Sub-Investigator) with DSI, that you agree to:

respect your patients' rights and well-being
to conduct the drug trial in compliance with the principles of GCP (Good Clinical Practice)
to maintain compliance with ICH (International Conference on Harmonization)
the CFR (Code of Federal Regulations), Title 45, Part 46
the Nuremberg Code
the most recent version of the Declaration of Helsinki
the Belmont Report
familiarize yourself with these fundamental principles of good medical research. You can find helpful links to help your review in the Suggested Reading section of this web site.

Your signature below attests to your willingness to act as a Sub-I with DSI on an IND, to respect the confidentiality of your patients' records and the proprietary information of the sponsors that will be shared with you. In addition, that you will abide by all applicable local laws and adhere to all regulatory requirements relevant to the use of new therapeutic agents.

Sincerely,

Joseph Saponaro, MD, DABIM, FACP, CPI, CCRI, CCRC, CCRP
Principal Investigator

Melody I. Sanger, BSN, RN, MD, CCRC, CCRP
Director of Clinical Research

Dr. (print name)_________________________________

Dr. (sign name)_________________________________

Date___________________

Please fax this Drug Trial Agreement back to DSI at 561-745-6664, along with copies of your:

Curriculum Vitae
Medical License
DEA Certificate
Occupational License
Board Certification