SMARTFORM 3.0 January, 2012 Overview of Major Changes

Why Make Changes? Feedback from customers – Annual Research Community Survey – IRB Post Approval Survey Many of the webridge questions are tedious and can be found in the protocol easily. Further, some standard questions (i.e. rationale of exclusion of HIV patients) are standard within cancer protocols and providing generic answers to satisfy the application process seems like a waste of effort. Feedback from IRB Analyst Pre-Review – Comprehensive evaluation of additional information most commonly requested during pre-review – Comprehensive review of questions posed during post –meeting correspondence Updates to address policy updates

Goals of the Enhancement Combine “Description of Research”, Item #3, Sample Size Information, and “Clinical Research Summary Form” Allow for abbreviated application for certain research types (HUD, Compassionate Use, Case Reports, etc) Combine “Inclusion/Exclusion” and “Subject Population Checklist”, and Item #8 Process of Informed Consent page Address redundancy between “Analysis of Specimens/Data” and Prospective Collection page Address overlap in questions related to the use of investigational drugs and investigational devices Address redundancy among SCRO subpages Revise prompts for relying on approvals issued by a non-CSMC IRB Revise NCI IRB page to be inclusive of all reliance agreements Eliminate redundant questions Improve guidance and help text Update previous GCRC pages to reflect recent CTSA grant

Any new staff team member added or deleted is now notified via notification

Combined similar questions previously posed on three different pages, Description of Research, Clinical Research Summary and Sample Size Information

Converting Existing Studies Submissions in Process to Be Converted by IRB Analysts Approved Studies to be Converted by Study Staff at first Amendment

DATA MIGRATION Existing responses to questions in approved studies and studies in progress maintained Related responses transferred over using background scripts Default responses entered for new questions

Edits to Continuation SMARTFORM Generalize for all facilitated review submissions Require additional information regarding DSMB reports Allow separate uploads for different reports Allow uploads for closure notices Add questions related to prior re-consent

Edits to Amendment SMARTFORM Combining discussion of proposed modifications and need for reconsent Clarification of wording