Complete the Study Properties. Watermarks are provided to help you determine the types of data you should enter. All fields are required and are marked with a red asterisk.
Field
Description
Study Name*
Type a name for your study, using up to 91 characters.
Expected Study Start Date*
Select the start date for your study from the drop-down calendar.
Unique Protocol ID*
Type a unique protocol ID for your study.
Protocol Type*
Select a protocol type from the drop-down list.
Expected Enrollment*
Type the expected enrollment number, using up to 10 characters. Note: This number is for informational purposes only, and can be exceeded as necessary.
Principal Investigator*
Type the name of the principal investigator for the study, using up to 100 characters.
Brief Summary*
Type a brief summary of the purpose of the study, using up to 2000 characters.
Sponsor Name*
Type the sponsor name. The sponsor name is auto-populated from your profile’s company name. It can be changed as needed.
Study Type*
Select the study type from the drop-down list.
Select Study Plan*
Select the study plan from the drop-down list. See Plans and Pricing.
Therapeutic Area*
Select the therapeutic area related to your study from the drop-down list.
Features Add-On
Select the feature(s) you want to add to your study: Medical Coding, Randomization, ePro or eSource. Note: Additional setup fees may apply.
To create a study with the default options, click Submit.
Click Continue to customize the study options.
Option
Setting
Allow Discrepancy Management
Yes (Default) enables notes and discrepancy workflow.
No
Require Reason For Change
Yes (Default) requires a reason for change when a form is marked Completed.
No
Allow SDV With Open Queries
Yes allows forms to be Source Data Verified even if they have open queries. If a form is changed as a result of resolving a query, it will lose its Source Data Verified status.
No (Default)
Allow Dynamic Groups Management
Yes (Default) allows subjects to be manually reassigned to a different Dynamic Group.
No
Allow Discrepancy Correction Forms
Yes (Default) enables notes and discrepancy to be created in PDF format to be emailed or faxed to sites for resolution. This feature allows sites without access to Captivate to participate in a study.
No
Study Environment
This option designates the study environment. It is set automatically and cannot be changed.
Build indicates this is an @TEST study
Production
Message
Allows you to specify a message to be displayed when a user logs in a production study.
How to Generate Subject ID
– Subject ID must be entered manually.
– Subject ID is automatically generated but can be edited.
ubject ID is automatically generated and it cannot be edited.
Prefix
Site ID (Default) – The Subject ID is prefixed with the Site ID
Custom – A custom string can be specified to prefix the Subject ID
None – There is no prefix in the Subject ID
Separator
Custom (Default) – A custom character can be specified to separate the prefix from the Subject ID
None
Digits
3 (Default)- Number of digits in the Subject ID
4 to 6
Study Subject ID Label
Allows you to define a custom label for the Subject ID field.
Collect Secondary ID
– Subjects must be assigned a secondary ID
– Subjects may be assigned a secondary ID
Secondary ID Label
Allows you to define a custom label for the Secondary ID field, if it is required or optional.
Secondary ID Label Viewable
Yes (Default) – The Secondary ID Label is viewable during data entry.
No
Collect Date of Enrollment for Study
– Date of enrollment must be manually entered
Not Used (Default) – Data of enrollment is not collected
Date of Enrollment Study Label
Allows you to define a custom label for the Date of Enrollment field, if it is required or auto-generated.
Collect Gender
Yes – The gender must be collected when the subject is enrolled
No (Default)
Gender Label
Allows you to define a custom label for the Gender field, if it is required.
Collect Subject Date of Birth
– The complete date of birth is required when a subject is enrolled.
– The year of birth is required when a subject is enrolled.
Collect Person ID
– A subject must be assigned a Person ID. This allows identification of a subject that participates in multiple studies without requiring personally identifiable information.
– A subject may be assigned a Person ID.
– The Study Subject ID is automatically copied in Person ID.
Show Person ID on CRF Header
Yes (Default) displays the Person ID on the CRF header.
No
Collect Event Location
– Event location must be entered when the event is scheduled.
-Event location may be entered when the event is scheduled.
Collect Start Date
– Event start date must be entered when the event is scheduled.
-Event start date may be entered when the event is scheduled.
Collect Start Time
– Event start time must be entered when the event is scheduled.
-Event start time may be entered when the event is scheduled.
Start Date/Time Label
Allows you to define a custom label for the event Start Date/Time field, if it is required or optional.
Collect Stop Date
– Event stop date must be entered when the event is scheduled.
-Event stop date may be entered when the event is scheduled.
Collect Stop Time
– Event stop time must be entered when the event is scheduled.
-Event stop time may be entered when the event is scheduled.
Stop Date/Time Label
Allows you to define a custom label for the event Stop Date/Time field, if it is required or optional.
Item-Level SDV Settings
Use CRF Settings (Default) – The SDV settings defined while designing the form will be used.
Use Last Event Settings – The last event settings will be applied in future versions of a form
Merge CRF Settings with Last Event Settings – The newer SDV settings defined while designing the form will override the last event event settings, if they conflict.
Collect Interviewer Name
– The interviewer name must be entered when the data is collected.
– The interviewer name may be entered when the data is collected.
Interviewer Name Default
– The interviewer name field is left blank on the form and must be manually entered.
Collect Interview Date
– The interview date must be entered when the data is collected.
– The interview date may be entered when the data is collected.
Interviewer Date Default
– The interview date field is left blank on the form and must be manually entered.
Use autotabbing
Yes (Default) – Advances the cursor to the next field when the current field is fully entered.
No
Evaluate with context
Yes – Displays subject and event information when evaluating data in a form.
No (Default)
SAS Name Annotation
Yes (Default) – Automatically generates a SAS-compliant name for CRF item names that do not adhere to the SAS naming convention.
No
Show Year in the Calendar
Yes (Default) – Year can be picked in the calendar widget.
No
Assign Randomization Parameters to
– Subjects can be randomized into a Dynamic Group (Treatment Group)
– The randomization code is stored in the Subject ID.
Trial ID
Contains the Trial ID obtained from the randomization system when the study and randomization scheme were created.
CRF status after import
Preserve the current CRF Status (Default) – The CRF status is unchanged after data import.
Set CRF status using the status in the import file – The CRF status is set using the status contained in the import file.
Always Set CRF status to Completed – The CRF status is always set to Completed after data import.
Auto-schedule event during import
Yes – The event is automatically scheduled, if needed, during data import.
No (Default)
Auto-create subject during import
Yes – The subject is automatically created and enrolled, if needed, during data import.
No (Default)
Replace existing data if changed during import
Yes – Existing data is replaced during data import.
No (Default)
Replace existing data per
(Default) – The entire CRF data is replaced, if existing data is configured to be replaced (see option above).
Code with context
Yes – Displays subject and event information when coding.
No (Default)
Auto-code Dictionary Name
Allows you to specify a file name to save the medical codes used in the auto-code process. Using the same file name across multiple studies allows you to share these codes between them.
Auto-scheduling for Insert Rules
Yes (Default) – Automatically schedule an unscheduled event when inserting data with a rule
