Subject Data for CTMS report

In this report, you view all subject data at multiple sites within your study. This report is designed specifically for studies that need to send subject information to their clinical trial management system. Only a study team member with the required user roles can run and download this report.

Modes

Available in all 3 modes: Testing, Training, and Production

Permission required to run the report

Any user who's assigned the Run the Subject Data for CTMS Report permission can generate this report.

Prerequisites for running this report

• Visit IDs should only contain letters and numbers: To make sure visit IDs are mapped to subjects' data for this report, visit IDs must always be written using numbers and letters only.
• Demography forms should be standard:
  • A demography form should always be associated with the Screening visit in a study.
  • There should be only one demography form in the study.
  • Name of the form should always be "FORM_DEMOGRAPHICS" written in capital letters with an underscore character.
  • A demography form should always include: subject's initials, their date of birth, their gender, and the date of their informed consent.

Want more details about how to design visits and forms? Check out this topic on how to create visits

and this topic on how to create forms.

Filters

Table 2-1 Filters table

Filter	Description
File Type	Select TXT as the output type for the report.

Field descriptions

Note:

Fields that don't have any corresponding values are marked as N/A in the report.

Field	Description
SITE	A site's ID as entered by the site manager when they created the site
VSITE	The ID of the site where the visit took place
SYSKEY	Subject's GUID
SUBJECT	Subject ID
RANDNO	The subject's randomization number
VISIT	Name of the visit from study design
VISITNO	Visit ID
EVENTDTC	The visit's start date
INITIALS	Subject's initials
BRTHDTC	Subject's day of birth
DOBMON	Subject's month of birth
DOBYR	Subject's year of birth
SEX	Subject's gender
INFCNDTC	Date of the informed consent
SCRNDTC	Date when the subject was screened
SCRNFDTC	Date when the subject was screen failed
RANDDTC	Date when the subject was randomized
TERMDTC	Date when the subject was withdrawn from the study
COMPDTC	Date when the subject completed the study
SCRFALRN	Reason the subject was screen failed
WDRWRN	Reason the subject was withdrawn from the study
OTHRN	Other reason for subject withdrawal

Note:

Since this report will be used to send subject data to another platform, there is a naming convention that must be followed. Always make sure your downloaded reports are named like this: <the protocol number>_<your product environment>_<the vendor's name>_<date of the generated report>.txt. For example, here's how a valid file name for the report would look like: CR-0207_UAT_ORACLE_08262019.txt.