Subject Identification Log (Report)

Summary

Formal Description in ICH-GCP

The Enrollment Log documents chronological enrollment of subjects by trial number.

The Subject Identification Code List documents that the investigator keeps a confidential list of names of all subjects allocated to trial numbers on enrolling in the trial. This list allows the investigator to reveal identity of any subject.

ClinSpark Description

Foundry Health chose to combine the Enrollment Log and the Subject Identification Code List into one report, called the Subject Identification Log. Therefore this report is to be stored at the investigator/institution only. This report allows the investigator/institution to reveal the identity of any subject.

This report fulfils the expectations set under ICH-GCP Essential Documents - section 8.3.21 & 8.3.22.

Requirements

#	Requirement	User Story	Acceptance criteria

#	Requirement	User Story	Acceptance criteria
1	Contain volunteer identifiable data.	As an end user, I am able to identify a volunteer based upon the data in the report.	Identifiable data available.
2	Report should be an excel file	As an end user, I should be able to open this report in Excel	Report is manageable in excel.
3	Should only list volunteers that have signed the main ICF for that particular trial.	As an end user, I don’t see the volunteers that came in for screening but left before ICF was signed	Volunteers that did not sign ICF are not listed.
4	Volunteers are to be enrolled in a chronological manner. The report should list all volunteers based upon their enrollment date/time.	As an end user, the order of the volunteers in the list reveals the order in which they were enrolled.	Volunteers listed per enrollment date/time.

Design

This report is not dependent on Form build. The input is based upon default ClinSpark fields/functionalities.

Data Mapping

Study Name

Name of the study displayed to users when navigating ClinSpark. Defined in the Study > Configure component.

ClinSpark

Report

Protocol Name

Protocol name of the study reported during data exporting. Defined in the Study > Configure component.

ClinSpark

Report

Study Site

Name of the site as defined in the Study > Configure component.

ClinSpark

Report

Investigator Name

Name of the Investigator as defined in the Study Site Basics section of a study’s Administration > Studies component.

ClinSpark

Report

Study Subject

Combination of the Randomization number, the Lead-in number, and the Screening number as available.

ClinSpark - Randomization number

Report

ClinSpark - Lead-in number

Report

ClinSpark - Screening number

Report

Cohort

Cohort within which subjects of interest are contained.

ClinSpark

Report

Volunteer ID

This is the unique identifier for each volunteer that follows the volunteer across studies.

ClinSpark

Report

First Name

Volunteer’s First Name as stored in the volunteer database.

ClinSpark

Report

Last Name

Volunteer’s Last Name as stored in the volunteer database.

ClinSpark

Report

Date ICF signed

Date on which the volunteer signed the Informed Consent for this particular study.