Identify and track enterprise-wide metrics of ongoing industry sponsored clinical trial activities

Indiana University Clinical Trials Office (IU-CTO): Negotiates, reviews, approves, and executes contracts (human subject clinical trials) supported by private industries and other for-profit entities

For more information, please contact the IU-CTO (insert link to the “Contact Us” navigation page)

Supports the IRBs and human research protection program.  It ensures education, research, and clinical activities are conducted in a manner that is consistent with applicable regulatory, statutory, and organizational requirements.

 

http://researchcompliance.iu.edu/cs.html

The IU and IU Health Investigators’ departments must email specific information to the IU-CTO to begin the CDA negotiation process.  Please email the following information:  the CDA (editable Word format), industry sponsor contact information, study or compound specific information, and IU/ IU Health Investigator and department contact information.  Email all information to the IU-CTO general mailbox at cto@iu.edu

Study Feasibility: Generally, an industry sponsor will provide a feasibility questionnaire to the investigator and study coordinator following the execution of the CDA.  The questionnaire is used to assess and determine: Investigator’s interest; existence of patient population; ability to recruit and enroll; capabilities; availability of qualified personnel; and access to equipment and facilities

*Each study varies.  Please contact the specific department for details.

Clinical Trial Agreement (CTA) & Budget: Legally binding agreement between two or more parties that details the terms and conditions for the conduct of a specific study and the obligations of each party.  Each CTA has a study-specific budget.  The intent of the budget is to detail payment terms and identify all costs to be incurred.
For more information, please contact the IU-CTO (insert link to the “Contact Us” navigation page)

Kuali Coeus Grants (KC Grants): Indiana University’s web-based approval process required for all clinical trials.  The approval process must be initiated by the investigator’s department.

KC Grants is an IU-hosted system protected by CAS authentication and can be accessed only by those with an IU computing account (username and passphrase).

*Please contact the specific department for updates.

Kuali Coeus IRB (KC IRB): Indiana University’s web-based system for entry and management of IRB submissions. All IRB submissions to the IU Human Subjects Office are made via KC IRB.  The Human Subjects Office uses KC IRB to manage submissions and maintain information about IRB committees and members.

KC IRB is an IU-hosted system protected by CAS authentication and can be accessed only by those with an IU computing account (username and passphrase).

*Please contact the specific department for updates.

Indiana University’s Clinical Trials Management System (CTMS) that provides an integrated system for managing studies.  The system is comprised of three specific applications: Clinical Research Management (CRM), Biospecimen Management (BSM) and Unified Registries Management (URM).  It is web-based and provides secure access to users from any location.

 

Additional OnCore information is available online

Indiana University Institutional Review Boards (IRBs) are responsible for the review and approval of all human subject research conducted at Indiana University and affiliated institutions, as well as, administers the human research protection program at Indiana University.

http://researchcompliance.iu.edu/hso/index.html

Western Institutional Review Board (WIRB) can be utilized in certain circumstances.  Please contact the Human Subjects Office for additional information

http://researchadmin.iu.edu/ora_faqs.html?data=wirb

A process in which study teams initiate/complete study-related activities: FDA 1572 form, financial disclosure form, investigator brochure, IRB documents, etc.

*Each study varies. Please contact the specific industry sponsor for details.

Once IRB documents are approved, the Human Subjects Office will post the approved versions in the KC IRB system. PIs and Study Coordinators can access and download these documents as needed.

*Please contact the specific department for IRB review and approval updates.

The IU and IU Health Investigators’ departments must email specific information to the IU-CTO to begin the CDA negotiation process.  Please email the following information:  the CDA (editable Word format), industry sponsor contact information, study or compound specific information, and IU/ IU Health Investigator and department contact information.  Email all information to the IU-CTO general mailbox at cto@iu.edu

The Indiana University Institutional Review Boards (IRB) are responsible for the review and approval of all human subject research conducted at Indiana University and affiliated institutions, as well as, administers the human research protection program at Indiana University.

Western Institutional Review Board (WIRB) can be utilized in certain circumstances. Please contact the Human Subjects Office for additional information

http://researchcompliance.iu.edu/hso/index.html

WIRB information

http://researchadmin.iu.edu/ora_faqs.html?data=wirb