Study Configuration

Overview

Study Configuration is used to set study information as well as setting supporting functions according to study protocol.

This guide consists of the following information:

To access the Build Study page, user needs to be logged in as study direct or data manager.

The layout of the page includes:

To configure the information and settings of the study, user needs to access the 'Study Configuration' function in the build study page

A dialogue to update study then appears.

Update A Study Dialogues has 5 tabs corresponding to 5 Groups of Information to Configure

Field	Description	Filling instructions
Unique Protocol ID	Unique Protocol ID is set by the sponsor. This Unique Protocol ID is unique and does not match any other protocols.	Maximum 30 characters
Brief Title	Short title of study is written in simple languages. Title should include information on participants, statuses being evaluated, and studied interventions	Maximum 100 characters
Official Title	Study's official title	Maximum 255 characters
Study System Status	Study's current status
Secondary IDs	Other IDs of the study	Can input multiple comma-separated IDs
Principal Investigator		Maximum 255 characters
Brief Summary
Detailed Description		Maximum 1000 characters
Sponsor		Maximum 255 characters
Study Phase	Current Study Phase	Select from one of many phases of a clinical trial Read more on phases in a clinical trial here.
Protocol Type		Select from one of the following: Interventional Observational
Protocol Verification / IRB Approval Date
Study Start Date
Study Completion Date
Purpose
Allocation	How study subjects are allocated in the study	Select from the following: N/A (not applicable) Randomized Nonrandomized Find out more here.
Masking		Select from the following: Open Single-Blind Double-Blind
Control		Select from the following: Placebo Active Uncontrolled Historical Does Comparision
Intervention Model		Select from a list of values. Find out more here.
Study Classification		Select study classification.

Trường dữ liệu	Bắt buộc	Hướng dẫn nhập liệu
Collect Subject Date of Birth?		Select from the following: Yes Only Year Of Birth Not Used
Allow Discrepancy Management?		Select from the following: Yes No
Sex Required?		Select from the following: Yes No
Person ID Required?		Select from the following: Required Optional Not Used
Show Person ID on CRF Header?		Select from the following: Yes No
Method to generate the Study Subject ID?		Select from the following: Manual Entry Auto-generated and Editable Auto-generated and Non-editable
Study Subject ID Auto Increment Strategy		Select from the following: By Site: Study Subject ID increments by site By Study: Study Subject ID increments by study
When Performing Data Entry, Interviewer Name Required?		Select from the following: Yes No Not Used
Interviewer Name Default as Blank?		Select from the following: Blank Pre-Populated from active user
Interviewer Name Editable?		Select from the following: Yes No
Interview Date Required?		Select from the following: Yes No Not Used
Interview Date Default?		Select from the following: Blank Pre-Populated from Study Visit
Interview Date Editable?		Select from the following: Yes No
Secondary Label Viewable?		Select from the following: Yes No
Forced Reason For Change in Administrative Editing?		Select from the following: Yes No
Visit Location Required?		Select from the following: Yes No Not Used
Auto Lock CRF After Sign?		Select from the following: Yes No
Auto Freeze CRF After Verify?		Select from the following: Yes No