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Human Subjects QA/QI

Clinical Research Management Templates

This page includes a collection of documents developed to assist research teams in the conduct of clinical trials. They focus mainly on the needs of investigator-initiated or non-industry funded studies but may be adapted for various types of studies.

Please note that research teams are not required to follow the documents exactly. Rather, these template documents are to be used as a starting point and will likely need to be customized to accommodate the needs of each individual study. Some of the documents are not applicable to all studies. Also, the nature of some research may warrant additions or changes to these forms or the development of additional tools related to specific research specialties or subject populations. Additionally, some sponsors, CROs, or federal agencies may require that investigators keep additional documents that are not specifically provided here. If you have questions regarding these documents or other human subjects research compliance issues, contact the QIO Human Subjects QA/QI Audit Team via the email listed under 'Contact Us' to the left of this page.

Prior to Study Initiation

Study Conduct

Informed Consent Process Documentation Templates:

Audit Preparation

Audit Preparation Checklist Templates:

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