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Screening Log (Report)
- Toma Holtzer
Summary
Formal Description in ICH-GCP
The Screening Log contains identification of subjects that entered pre-trial screening (Essential Documents - section 8.3.20)
ClinSpark Description
The Screening Log report provides an overview of the subjects that signed the Informed Consent, entered the screening phase and their final eligibility status.
Due to the fact that this report does not contain any identifying data of the volunteer, this report can be shared with the sponsor upon request.
This report fulfils the expectations set under ICH-GCP Essential Documents - section 8.3.20.
Requirements
# | Requirement | User Story | Acceptance criteria |
|---|---|---|---|
1 | Should not contain volunteer identifiable data. | As an end user, I should not be able to identify a volunteer based upon the data in the report | No identifiable data available. |
2 | Report should be a pdf document | As an end user, I should not be able to make changes to the report. | Report is pdf file. |
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 | I should be able to distinguish volunteers that have a final Subject Status from those that still have a temporary Subject Status. | As a end user, I’m informed about volunteers that have not been assigned a final Subject Status yet. | Volunteers that have Subject Status “Pending” or “Potential Eligible” are listed in red with the following statement applied: “Please provide final Subject Status” |
5 | For volunteers that signed the ICF but failed screening, failed criteria should be listed | As an end user, I see which criteria the volunteer failed for | Failed in and/or excl criteria are listed |
6 | Volunteers that withdrew their consent should be listed. | As an end user, I see which volunteers withdrew there consent. | “Withdrawn” is listed in case the volunteer withdrew his consent to participate in the trial |
Design
This report is not dependent on Form build. The input is based upon default ClinSpark fields/functionalities. The way sites check inclusion and exclusion criteria (Met/Not Met) might have an impact on the report. In addition, adding Eligibility result descriptions are not taken into account in this default report. A customization will be needed in such case.
This report takes into account one study site per study only.
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
Cohort
Cohort within which subjects of interest are contained.
ClinSpark
Report
Date ICF signed
ClinSpark
Report
Study Subject
Combination of the Randomization number, the Lead-in number, and the Screening number as available.
ClinSpark - Randomization number
ClinSpark - Lead-in number
ClinSpark - Screening number
Report
Subject eligibility result
Outcome of the eligibility check performed per subject. Foundry Health will make the following Eligibility result types - Elgibility result description combinations available in any bootstrapped environment:
Eligible - Eligible
Eligible - Reserve or Standby
Ineligible - Ineligible
Pending - Pending
Unspecified - Unspecified
Sites can add additional combinations, but all of them relate back to the 4 types. If the site adds a new combination and needs this additional option to be reflected in the Screening Log report, a customization of the report will need to be requested/performed.
ClinSpark
Report
Reason for screening failure - Withdrawn
The volunteer withdrew the informed consent and therefore is not allowed to continue the trial.
ClinSpark
Report
Reason for screening failure - Failed inclusion and/or exclusion criteria
The volunteer did not fulfill certain criteria and should therefore not continue the trial.
ClinSpark
Report
Reason for screening failure - Reserve or Standby
A “Reserve or Standby” can be asked to participate in the trial if one of the other eligible volunteers becomes ineligible on Day -1.
ClinSpark
Report
Reason for screening failure - Correction needed
These volunteers have not been assigned a final status yet.
ClinSpark
Report
Exported and Printed Copies Are Uncontrolled