This is an example 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 that for randomization events, EPOCH = "SCREENING", because randomization occurred before the start of product exposure, during the screening epoch. | Rows 3-5: | Show 3 records for a subject who completed 3 stages of the study ("SCREENING", "PRODUCT 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 protocol 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 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 product 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 product exposure epoch due to an adverse experience, but who went on to complete the follow-up 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 | PRODUCT 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 | PRODUCT 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 | PRODUCT 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 EXPERIENCE | DISPOSITION EVENT | STUDY PARTICIPATION | PRODUCT 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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CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology Code List Name | CRF Implementation Notes | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden |
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DSCAT | 1 | What was the category of the disposition? | Disposition Category | If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended. | Text | DSCAT | (DSCAT) | DISPOSITION EVENT | prompt | Yes | DSDECOD | 2 | What was the subject's status? | Status | Document the subject's status at study completion. If the subject discontinued prematurely, record the primary reason for discontinuation. | Text | DSDECOD | (NCOMPLT) | The Controlled Terminology (NCOMPLT) is focused on disposition events, and is used when DSCAT is "DISPOSITION EVENT". | COMPLETED; ADVERSE EVENT; DEATH; DISEASE RELAPSE; LACK OF EFFICACY; LOST TO FOLLOW-UP; NON-COMPLIANCE WITH STUDY DRUG; PHYSICIAN DECISION; PREGNANCY; PROGRESSIVE DISEASE; PROTOCOL DEVIATION; RECOVERY; SITE TERMINATED BY SPONSOR; STUDY TERMINATED BY SPONSOR; TECHNICAL PROBLEMS; WITHDRAWAL BY PARENT/GUARDIAN; WITHDRAWAL BY SUBJECT | radio | DSTERM | 3 | If adverse event, specify | Specify | If Adverse Event is selected from the Status list, provide the verbatim reason. | Text | DSTERM | If DSTERM was collected as an adverse event, Specify", populate the SDTMIG variable DSTERM with the free text and populate DSDECOD with the standardized text from (NCOMPLT). | prompt | DSSTDAT | 4 | What was the study completion/discontinuation date? | Study Completion/Discontinuation Date | Record the date that the subject completed the study using this format (DD-MON-YYYY). If the subject did not complete the study, record the date that the subject discontinued. | Date | DSSTDTC | DSSTTIM | 5 | What was the study completion/discontinuation time? | Study Completion/Discontinuation Time | Record the time (as complete as possible) that the subject completed the study. If the subject did not complete the study, record the time (as complete as possible) that the subject discontinued. | Time | DSSTDTC