Study Configuration

Owned by
Linh Tran (Unlicensed)
Last updated: May 08, 2018
2 min read

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:

Build Study Page

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

Build Study Interface

The layout of the page includes: 

  • Change Study Status: Quickly change the status of the current status
  • Build Study Tasks: List of tasks to be completed in the study building process
  • Site List: list of sites of the study
  • CheckPad's extensions: 
    • ePro
    • Randomization

Update Study Configuration

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

Study Description and Status

Field
Required?
Description
Filling instructions
Unique Protocol ID(tick)

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(tick)

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 titleMaximum 255 characters
Study System Status(tick)Study's current status
Secondary IDs(tick)Other IDs of the studyCan input multiple comma-separated IDs
Principal Investigator(tick)
Maximum 255 characters
Brief Summary(tick)

Detailed Description

Maximum 1000 characters
Sponsor(tick)
Maximum 255 characters
Study Phase(tick)

Current Study Phase

Select from one of many phases of a clinical trial

Read more on phases in a clinical trial here.

Protocol Type(tick)

Select from one of the following:

  • Interventional
  • Observational
Protocol Verification / IRB Approval Date


Study Start Date(tick)

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.

Facility Information

Field
Required
Filling instructions
Facility Name
Maximum 255 characters
Facility City
Maximum 255 characters
Facility State/Province
Maximum 20 characters
Postal Code
Maximum 64 characters
Facility Country
Maximum 64 characters
Facility Contact Name
Maximum 255 characters
Facility Contact Degree
Maximum 255 characters
Facility Contact Phone
Maximum 255 characters
Facility Contact Email
Must follow email format

Related Information

Field
Required?
Filling instructions
MEDLINE Identifier
Maximum 255 characters
Results Reference?

URL Reference
Maximum 255 characters
URL Description
Maximum 255 characters


Study Parameter Configuration

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?

  • 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