Clinical Trials Management System
CA-01
About This Policy
- Effective Date:
- 04-21-2016
- Date of Last Review/Update:
- 04-21-2016
- Responsible University Office:
- Clinical Trials Office
- Responsible University Administrator:
- Executive Vice President for University Clinical Affairs
- Policy Contact:
- Ken Carlson
Director, Clinical Trials Office
khcarlso@iu.edu
Scope
This policy applies to all Indiana University employees and affiliated staff, including IU Health, who engage in clinical research (as defined below), which originates from any location.
Policy Statement
It is the policy of Indiana University that all clinical studies shall be registered in OnCore, a clinical trials management system. For the purpose of this policy, “clinical study” shall mean any prospective research study using human subjects to evaluate biomedical or health-related outcomes. This term encompasses interventional and expanded access trials as well as observational studies requiring informed consent and long term adverse event reporting.
This policy applies in all situations and activities of the University where human subjects are used in research regardless of the source(s) of support and/or funding.
Reason for Policy
The use of a single clinical trials management system will promote the safety of study subjects and allow for greater efficiency in conducting studies. This policy provides guidance to ensure consistency and best practices in the management of clinical studies.
Definitions
Clinical Studies: any prospective research study using human subjects to evaluate biomedical or health-related outcomes. This term encompasses interventional and expanded access trials as well as observational studies requiring informed consent and long term adverse event reporting.
Sanctions
Failure to adhere to the principles and procedures of this policy may result in the delay of patient enrollment in clinical studies.