This is an example CRF used to collect the protocol milestone, and informed consent.
Example CRF: Protocol milestones (e.g., informed consent)
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This is an example CRF used to collect Disposition Events. In this study, subjects were randomized to a trial, which contain three phases. A screening phase, a "treatment phase", where subjects were required to use the tobacco product as described in the protocol, and a follow-up phase. The Disposition Event CRF was collected at the end of each phase of the trial. The sponsor may select the the Completion/Reason for Non-Completion terms from Controlled Terminology.
Example CRF :Study Participation Disposition Event
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Completion/Discontinuation Date
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Record if the subject will be continuing to the next trial period of this study.
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This is an example of an SDTM dataset used to represent the data collected on the above example CRFs and information on randomization.
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| Rows 1, 2, 6, 8, 9, 12, 13, 17, 18: | Show records for protocol milestones. DSTERM and DSDECOD are populated with the same value, the name of the milestone. Note Note that for randomization events, EPOCH = "SCREENING", because randomization occurred before the start of treatmentproduct exposure, during the screening epoch. | | Rows 3-5: | Show 3 records for a subject who completed 3 stages of the study ("SCREENING", "TREATMENTPRODUCT EXPOSURE", "FOLLOW-UP"). | | Row 7: | Shows disposition of a subject who was a screen failure. The Disposition CRF showed that the subject discontinued for a " PROTOCOL DEVIATION ". The specify reason the subject was a screen failure was then collected using DSTERM. Because the subject did not complete the screening epoch, DSDECOD is not “COMPLETED” but another appropriate controlled term, "PROTOCOL DEVIATION ". The date of discontinuation is in DSSTDTC. The protocol deviation event itself would be represented in the DV dataset. | | Rows 10-11: | Show disposition of a subject who completed the screening stage but did not complete the treatment stageprotocol exposure epoch. For completed epochs, both DSTERM and DSDECOD are "COMPLETED". For epochs that were not completed, the verbatim reason for non-completion of the treatment product exposure epoch is in DSTERM, while the value from controlled terminology is in DSDECOD. | | Rows 14-16: | Show disposition of a subject who completed treatmentproduct exposure epoch, but did not complete follow-up. Note that for final disposition event, the date of collection of the event information, DSDTC, was different from the date of the disposition event (the subject's death), DSSTDTC. | | Rows 19-21: | Show disposition of a subject who discontinued the treatment product exposure epoch due to an adverse eventexperience, but who went on to complete the follow-up phase epoch of the trial. |
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| Row | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | DSSCAT | EPOCH | DSDTC | DSSTDTC |
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| 1 | ABC123 | DS | 123101 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-21 | 2003-09-21 | | 2 | ABC123 | DS | 123101 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-30 | 2003-09-30 | | 3 | ABC123 | DS | 123101 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-09-30 | 2003-09-29 | | 4 | ABC123 | DS | 123101 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | TREATMENTPRODUCT EXPOSURE | 2003-10-31 | 2003-10-31 | | 5 | ABC123 | DS | 123101 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2003-11-15 | 2003-11-15 | | 6 | ABC123 | DS | 123102 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
| SCREENING | 2003-11-21 | 2003-11-21 | | 7 | ABC123 | DS | 123102 | 2 | SUBJECT DENIED MRI PROCEDURE | PROTOCOL VIOLATION | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-11-22 | 2003-11-20 | | 8 | ABC123 | DS | 123103 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-15 | 2003-09-15 | | 9 | ABC123 | DS | 123103 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-30 | 2003-09-30 | | 10 | ABC123 | DS | 123103 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-09-30 | 2003-09-22 | | 11 | ABC123 | DS | 123103 | 4 | SUBJECT MOVED | LOST TO FOLLOW-UP | DISPOSITION EVENT | STUDY PARTICIPATION | TREATMENTPRODUCT EXPOSURE | 2003-10-31 | 2003-10-31 | | 12 | ABC123 | DS | 123104 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-15 | 2003-09-15 | | 13 | ABC123 | DS | 123104 | 3 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-30 | 2003-09-30 | | 14 | ABC123 | DS | 123104 | 2 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-09-30 | 2003-09-22 | | 15 | ABC123 | DS | 123104 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | TREATMENTPRODUCT EXPOSURE | 2003-10-15 | 2003-10-15 | | 16 | ABC123 | DS | 123104 | 5 | AUTOMOBILE ACCIDENT | DEATH | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2003-10-31 | 2003-10-29 | | 17 | ABC123 | DS | 123105 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-28 | 2003-09-28 | | 18 | ABC123 | DS | 123105 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
| SCREENING | 2003-10-02 | 2003-10-02 | | 19 | ABC123 | DS | 123105 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-10-02 | 2003-10-02 | | 20 | ABC123 | DS | 123105 | 4 | ANEMIA | ADVERSE EVENTEXPERIENCE | DISPOSITION EVENT | STUDY PARTICIPATION | TREATMENTPRODUCT EXPOSURE | 2003-10-17 | 2003-10-17 | | 21 | ABC123 | DS | 123105 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2003-11-02 | 2003-11-02 |
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