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|Use of Screen Failure Terminology in SDTM Implementation Guide 3.1.1 |
One thing that strikes me when I read the SDTM Implementation Guide is the incorrect use of the term ‘Screen Failures’. For example in Section 5.1.1 (DM domain), it states that the values of RFSTDTC and RFENDTC are usually defined to be null for screen failures (see page 35). In Section 188.8.131.52 (page 37), item 8, it starts off with “Data for screen failure subjects, if submitted”. In 6.2.2 (DS Domain), the DSDECOD variable includes “SCREEN FAILURE” as an example of a disposition event.
In the CDISC Clinical Research Glossary (Version 5.0), the term Screen Failure is defined as: “Potential subject who did not meet one or more criteria required for participation in a trial.” This definition is consistent with the historical use of the term in that a Screen Failure is a person who is considered for entry into a clinical trial but never is enrolled into the trial. The defining event that makes a person enrolled in a clinical trial is the completion of informed consent. Once this is performed, the person is a subject and should be assigned a unique subject identification number. People who do not complete the informed consent process are the Screen Failures and no subject identification number is assigned and no CRF is completed. For some trials, the investigators are asked to keep screening logs which contain minimal information such as age, sex, date screened, and primary reason (s) why the person is not enrolled into the study. Reasons why a person was not enrolled could include, prohibited concomitant medication, coexistent disease, patient refused, disease criteria not satisfied. Investigators could determine that a person was a Screen Failure simply by going though patient charts for their office. The FDA has occasionally required the sponsor to summarize the number of Screen Failures by primary reason for not enrolling so that they can determine if the trial population is representative of the general population with the disease to be treated by the investigational drug.
The use of “Screen Failure” in the implementation guideline is incorrect because no identifiable individual data is ever received by the sponsor. I am unaware of any term for enrolled subjects who do not get randomized. “Entry Failure” or “Enrollment Failure” are two potential terms but I prefer to use “Enrolled, not Randomized” to describe such subjects. Part of the reason why is because subjects may go through an open-label treatment period or a baseline qualification period prior to randomization and you may want to distinguish the different groups, “Enrolled, no open-label treatment”, “Open-label treatment, not randomized”, etc.
Perhaps this could be clarified by changing the name of the “Screening Visit” to “Enrollment Visit” which is more consistent with what it actually is.
I recommend that the “Screen Failure” wording be removed in the implementation guide.
|Response from the SDS Team: |
The subject-flow process described seems accurate, so I'm not sure where the issue is. The only difference I see is that the text below states, "People who do not complete the informed consent process are the Screen Failures and no subject identification number is assigned and no CRF is completed." However, the SDS Team considers screen failures to be as described in the glossary, as cited below: a subject who did not meet one or more criteria required for participation in a trial." This definition is consistent with the historical use of the term in that a Screen Failure is a person who is considered for entry into a clinical trial but never is enrolled into the trial. In my experience, a person who doesn't sign an informed consent is not generally considered to be a screen failure.
Within the SDS Team, there were enough sponsors who collected data on subjects who did not meet entry criteria that methods to represent their presence (ARM/ARMCD in DM), the criteria not met (IE), and their disposition (DS) were addressed in the SDTMIG. Some sponsors choose to submit data on these subjects for various reasons. Such subjects may sign an informed consent so that various procedures such as vital-signs or blood-sample collection may be performed in order to check against entry criteria.
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