All subjects who are screened must be entered into Veeva RTSM. A subject who screen fails has signed the Informed Consent Form (ICF), but does not meet all eligibility criteria and are not subsequently randomly assigned to the study treatment or enrolled in the study. Screen failures may be re-screened at the discretion of the site investigators (and should be assigned the same subject number as for the initial screening).
The original ICF and screening documentation for these subjects should be maintained at the site. There are no follow-up requirements for these subjects.
A minimal set of screen failure information is required to ensure transparent reporting of screen failure subjects to regulatory authorities and/or to meet publishing requirements. Minimal information includes demographic details, inclusion/exclusion criteria and any AEs meeting protocol reporting requirements.
Please complete the following in Veeva EDC:
- Create a subject record using the Create a New Subject in EDC tabin Veeva RTSM
- Once Subject ID is generated in Veeva CDMS (following creation of subject record in Veeva RTSM), complete the following CRFs in Veeva CDMS:
- Informed Consent CRF
- Enrollment and Randomization Stratum Enrollment CRF
- Recipient Inclusion Exclusion Criteria Not Met CRF
- CRF should indicate which eligibility criteria the recipient did not meet, if applicable.
- Donor Inclusion/Exclusion CRF
- CRF should indicate which eligibility criteria the donor did not meet, if applicable.
- Demographics CRF
CCG v1.0 | CRF v1.3
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