Form Builder: Hopkins-wide Data Collection Tool for Research Projects Joseph Finkelstein, MD, PhD Chronic Disease Informatics Program Johns Hopkins University

Clinical Research Management System (CRMS) CRMS is a web-based tool designed to organize and streamline clinical research management CRMS is supported by The Johns Hopkins Institute for Clinical and Translational Research (ICTR) It is designed to improve communication among study team members, store subject enrollment information in a secure location, and run real- time reports CRMS modules Subject Recruitment, Case Report Forms (Form Builder), Subject & Protocol Registry, Specimen Tracking, Protocol Schema & Patient Calendar, Data Warehouse, Financial Management Accessible by JHED ID, CRMS supports electronic forms, integrates with eIRB, and tracks signed consent forms http://ictr.johnshopkins.edu/ictr/2009/12/clinical-research-management-system-crms.html#more

Form Builder Form Builder is one component of CRMS This web-based tool allows researchers to build forms that are scientifically rigorous and user-friendly

Basic Functionality Form Level Research Protocol Level Form creation, storage, modification, deletion Data collection using web-based CRF Embedded CRF instructions Assigning multiple categories to the forms Form search Research Protocol Level Support main requirements for controlled randomized trials which include: Double entry, Blinding, Scoring, Reporting, Alerting, and Exporting operations with CRF for each trial Ability to limit access to their CRF by members of other research protocols Enterprise Level Maintaining and warehousing of research data coming from different research protocols Implement industry standards for naming and transmission of research data Ability to operate and store CRF in Hopkins data warehouse on an aggregate level

Form Library Display

Building Forms I Enter variable name (how you want to code it) and question text (how you want it to appear on the form). Data type: Date, Datetime, Float, Integer, Measurement, Multi-response, Option, String, Tabular, Temperature, Text, Time

Building Forms II

http://cdip. med. jhmi. edu/intro/Investigators/investigators_main http://cdip.med.jhmi.edu/intro/Investigators/investigators_main.aspx

Submission of forms

Stage I

Stage II

Repository of Questionnaires, Surveys, and Tools (ReQueST)

Any questions http://cdip.med.jhmi.edu/intro/Investigator s/investigators_main.aspx Email jfinkel9@jhmi.edu Right now we are putting together a Form Committee and if anyone is interested, please email me.