1 / 23

SMARTFORM 3.0 January, 2012

SMARTFORM 3.0 January, 2012. Overview of Major Changes. Why Make Changes?. Feedback from customers Annual Research Community Survey IRB Post Approval Survey

casper
Download Presentation

SMARTFORM 3.0 January, 2012

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. SMARTFORM 3.0January, 2012 Overview of Major Changes

  2. 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

  3. 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

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

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

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

  7. 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

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

More Related