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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| CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Value | 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="PROTOCOL MILESTONE" where DSDECOD and DSTERM="INFORMED CONSENT OBTAINED" | (DSCAT) | Refer to the SDTMIG for guidelines for assigning DSCAT, DSTERM, and DSDECOD for events considered protocol milestones. |
| PROTOCOL MILESTONE | prompt |
| Yes | | DSSTDAT | 2 | What was the informed consent date? | Informed Consent Date | Record the date of informed consent as defined in the protocol and/or CRF completion instructions using this format (DD-MON-YYYY). | Date | DSSTDTC |
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| | DSSTTIM | 3 | What was the informed consent time? | Informed Consent Time | Record the time (as complete as possible) of informed consent as defined in the protocol and/or CRF completion instructions. | Time | DSSTDTC |
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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 epochs. A screening epoch, a product exposure epoch,, where subjects were required to use the tobacco product as described in the protocol, and a follow-up epoch. The Disposition Event CRF was collected at the end of each epoch 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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| CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | 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 | | EPOCH | 2 | What is the trial epoch for this disposition event? | Epoch | Select the trial epoch for which disposition is being recorded. | Text | EPOCH |
| (EPOCH) | SCREENING; PRODUCT EXPOSURE; FOLLOW-UP; |
| prompt | radio |
| | DSSTDAT | 3 | What was the completion/discontinuation date? | Completion/Discontinuation Date | Record the date that the subject completed the study or trial period using this format (DD-MON-YYYY). If the subject did not complete the study or trial period, record the date that the subject discontinued. | Date | DSSTDTC |
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| | DSSTTIM | 4 | What was the completion/discontinuation time? | Completion/Discontinuation Time | Record the time (as complete as possible) that the subject completed the study or trial period as defined in the protocol. If the subject did not complete the study or trial period, record the time (as complete as possible). | Time | DSSTDTC |
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| | DSDECOD | 5 | What was the subject's status? | Status | Document the subject's status for the study or trial period. If the subject discontinued prematurely, record the primary reason for discontinuation. | Text | DSDECOD |
| (NCOMPLT) | COMPLETED; ADVERSE EVENT; DEATH; LOST TO FOLLOW-UP; NON-COMPLIANCE WITH STUDY PRODUCT; PHYSICIAN DECISION; PREGNANCY; PROTOCOL DEVIATION; SITE TERMINATED BY SPONSOR; STUDY TERMINATED BY SPONSOR; WITHDRAWAL BY SUBJECT; OTHER |
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| | DSTERM | 6 | If other, specify | Specify | If Adverse Event, Death, Protocol Deviation or Other is selected from the Status list, provide the verbatim reason. | Text | DSTERM |
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| | DSCONT | 7 | Will the subject continue? | Continue | Record if the subject will be continuing to the next trial period of this study. | Text | SUPPDS.QVAL | SUPPDS.QVAL when SUPPDS.QNAM= "DSCONT" and SUPPDS.QLABEL="Subject Continue". | (NY) | No; Yes |
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| | DSNEXT | 8 | What is the next epoch the subject will continue to enter? | Next epoch | Record the planned subsequent trial epoch in which the subject intends to participate. | Text | N/A |
| (EPOCH) | PRODUCT EXPOSURE; FOLLOW-UP; |
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This is an example of an SDTM dataset used to represent the data collected on the above example CRFs.
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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 prouduct 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 event, 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 EVENT | 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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