The Resident and New Investigator Program includes training resources to help program directors fill their training gaps:

• Observational Research Study Design – live webinar training
• CITI Program Research Study Design – NEW*
• CITI Program Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov – NEW*
• Literature search, protocol-writing and research project advice articles
• Helps prepare studies for publication

* Available with 3 year subscription for CITI Program members.

Faculty and residents program-wide can use a common tool to collaborate on writing protocols for research projects:

• Online tool available 24/7
• Standardize template options include Chart Review, Observational, Repository and Interventional templates
• Faculty can create starter protocols to share with students for them to edit
• Needs Review List alerts users to section changes in the protocol that need to be reviewed
• Commenting options including in-line editing with before/after comparison and Commenting Tool.

Templates, content and tools to help comply with IRB requirements and lower IRB support needs:

• Section guidance and sample content for all templates has been CIP and IRB Director review – now updated to reflect Revised Common Rule guidance.
• Standard protocol templates need to be followed – sections cannot be deleted or changed
• Protocol dashboard and section completeness indicators drive 100% completeness of protocols*
• Resource Center content supports understanding of regulations and protocol writing – including the recent Revised Common Rule.

* Hollis, S., Irvine, K. “Can technology tools improve the protocol-writing process?  A Proof of Concept Study by Ascension Healthcare System”; August 2018.

Proof of Concept: 85% less IRB support costs

Read about Ascension Health’s proof of concept study results – 85% less IRB support costs and 100% protocol completeness.