Overview

Updating a study allows you to modify various aspects of an existing clinical trial configuration. The Study Setup page is organized into sections that you can navigate via the left sidebar. Changes can be saved at any time using Save changes or Save & Overview.

Accessing Study Setup

1. From Home, select the study you want to update (e.g., "Tam Study").
2. The Study Setup page opens with the following sections in the sidebar:
   • Study Description
   • Default Facility Information
   • Study Parameter Configuration
   • Event Parameter Configuration
   • New Subject Enrollment Email
   • Email Template

Build Your Study in Detail

This process is to define your study in details including: Manage Events, Sites list, Add Case Report Forms to each event, Define dynamic rules such as auto calculated values, and add users into your study.

Use this study workspace URL pattern to access the build flow:

• https://[instance]/home/study/[studyId]

Recommended order: Follow the steps in the order below. Some steps have dependencies — for example, the Randomization app reads treatment arm codes from the Subject Group Class, so Step 3 must be completed before configuring Randomization. Rules referencing CRF items require the CRF to be in Available status.

Step 1. Manage CRFs (Forms)

• Workspace URL: https://[instance]/home/study/[studyId]/build/crfs
• Create, organize, and maintain all Case Report Forms used in your study.
• Define form structures and required fields before assigning forms to events.
• Build each CRF in the Form Builder app with field OIDs that you'll reference in rules.
• CRFs must be in Available status before they can be assigned to events or used in Rule Studio.

Step 2. Manage Events

• Workspace URL: https://[instance]/home/study/[studyId]/build/events
• Configure study visits and event timelines (Screening, Baseline, Week 4, etc.).
• Add and map relevant CRFs to each event so data collection is aligned with protocol flow.
• Include Unscheduled events (e.g., Early Termination) where appropriate.

Step 3. Manage Subject Group Class

• Workspace URL: https://[instance]/home/study/[studyId]/build/study-group-classes
• Create treatment arm groups used for randomization (e.g., Treatment Arm with TRT / PBO codes).
• Must be completed before configuring the Randomization app — treatment arm codes are read from this class.
• For a 1:1 RCT: create an "Arm" type class, add two groups with equal weights (1:1).

Step 4. Edit checks or Rules

• Workspace URL: https://[instance]/home/study/[studyId]/build/rules
• Define dynamic study logic: auto-calculated fields (BMI, age), range validations, and cross-field checks.
• Use the Item[OID] syntax to reference CRF fields in expressions.
• Confirmed working expressions:
  • BMI: round(10000 * Item[WEIGHT_KG] / Item[HEIGHT_CM] / Item[HEIGHT_CM])
  • Age at Consent: getYear(CURRENT_DATE) - getYear(Item[DATE_OF_BIRTH])
• Set trigger items by dragging fields from the Items panel to the trigger drop zone.

Step 5. Manage Sites

• Workspace URL: https://[instance]/home/study/[studyId]/build/sites
• Add all participating research sites with their site name, site ID, and Principal Investigator.
• For multi-site studies: each site gets its own numeric unique site ID.

Step 6. Manage Users

• Workspace URL: https://[instance]/home/study/[studyId]/build/users
• Add users to the study and assign appropriate roles (Investigator, CRC, Monitor, Study Admin, etc.).
• Users must already have system accounts before they can be assigned to a study.

Study Description

Update the core metadata and description of your study:

Field	Description
Study Name	Internal name for the study
Brief Title	Short title for the study
Brief Summary	Concise summary of the study
Unique Protocol ID	Unique identifier for the protocol
Secondary IDs	Additional protocol identifiers
Principal Investigator	Name of the principal investigator
Official Title	Full official study title
Detailed Description	Extended description of the study
Sponsor	Study sponsor name
Collaborators	Collaborating organizations

Study Type and Enrollment

• Interventional or Observational — Select the study type
• Expected total enrollment — Number of subjects expected
• Study Start Date — Use the date picker or Now button
• Study Completion Date — Target completion date
• Protocol Verification/IRB Approval Date — Approval date

Document Requirements

Configure document labels (e.g., "Hình ảnh") with usage options:

• Required — Document must be uploaded
• Optional — Document may be uploaded
• Not used — Document type is disabled

Default Facility Information

Set default facility details that apply across the study:

Field	Description
Facility Name	Name of the facility
Facility City	City location
Facility State/Province	State or province
Facility ZIP	Postal/ZIP code
Facility Country	Country
Facility Contact Name	Primary contact name
Facility Contact Degree	Contact's degree or title
Facility Contact Phone	Contact phone number
Facility Contact Email	Contact email address

Study Parameter Configuration

Subject ID Format

Choose how subject IDs are generated:

• Manual Entry — Site staff enters IDs manually
• Auto-generated and Editable — System generates IDs; staff can edit
• Auto-generated and Non-editable — System generates IDs; staff cannot edit

For auto-generated IDs, configure:

• Prefix — Short alphabetic prefix identifying the study (e.g., "CR" for CARDIO-RELIEF)
• Separator — Usually "-" (hyphen)
• Length — 3, 4, 5, or 6 digits (4 is typical for studies up to 9999 subjects)
• Preview Subject ID — Shows the format live (e.g., "CR-0001")
• Study Subject ID Label — Label displayed in the UI (e.g., "Participant", "Subject", "Patient")

Subject Parameters

Configure standard subject fields as Required, Optional, or Not used:

• Document labels
• Sex
• Date of birth (Year / Month and year / Day, month and year)
• Additional custom parameters with custom labels

Event Parameter Configuration

Configure event-level parameters:

• Subject Status — Required, Optional, or Not used
• Start Date/Time — When the event begins
• End Date/Time — When the event ends
• Allow subject to be randomized — Yes or No
• Allow subject to be unblinded — Yes or No

New Subject Enrollment Email

Configure email notifications when new subjects are enrolled:

• Recipients — Select roles that receive the email:
  • Study Administrator
  • Study Monitor
  • Study Sponsor
  • Study Coder
  • Study Evaluator
  • Site Monitor
  • Investigator
  • Clinical Research Coordinator
  • Facility Contact
  • Other Recipients
• Email Subject — Subject line of the email
• View all Variables — Insert dynamic variables into the template

Email Template

Customize the email template content for new subject enrollment notifications.

Saving Changes

• Save changes — Saves your updates and stays on the current section
• Save & Overview — Saves and returns to the study overview

Best Practices

• Document the reason for changes in your study records
• Test updates in a development environment first when possible
• Ensure compliance with regulatory requirements
• Inform relevant team members about updates that affect data collection
• Backup or export study data before major configuration changes

Troubleshooting

If you encounter issues while updating a study:

• User permissions — Ensure you have Study Administrator or appropriate rights
• Data integrity — Some changes may be restricted if subjects are already enrolled
• Required fields — Complete all required fields before saving
• Version compatibility — Check that your platform version supports the changes