In this example, the Disposition CRF simply collects whether or not the subject completed each trial epoch. There is one record for each epoch the subject entered.
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title | CDASH DS Metadata Specifications |
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Metadataspec |
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Order | Question Text | Prompt | CRF Completion Instructions | CDASH Variable Name | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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1 | What was the category of the disposition? | Disposition Category | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. | DSCAT | DSCAT |
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| DISPOSITION EVENT | 2 | What is the trial epoch for this disposition event? | Epoch | Select the study epoch for which disposition is being recorded. | EPOCH | EPOCH |
| (EPOCH) | SCREENING; PRODUCT EXPOSURE; FOLLOW-UP; |
| 3 | What was the completion/discontinuation date? | Completion/Discontinuation Date | Record the date that the subject completed the study or study period using this period using this format. If the subject did not complete the study or study period, record the date that the subject discontinued. | DSSTDAT | DSSTDTC |
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| 4 | What was the subject's status? | Status | Document the subject's status for the study or study period. If the subject discontinued prematurely, record the primary reason for discontinuation. | DSDECOD | DSDECOD |
| (NCOMPLT) | COMPLETED; ADVERSE EXPERIENCE; DEATH; LOST TO FOLLOW-UP; NON-COMPLIANCE WITH STUDY PRODUCT; PHYSICIAN DECISION; PREGNANCY; PROTOCOL DEVIATION; SITE TERMINATED BY APPLICANT; STUDY TERMINATED BY APPLICANT; WITHDRAWAL BY SUBJECT; OTHER. |
| 5 | What was the verbatim reason for the subject status? | Specify | If Adverse Experiences, Death, Protocol Deviation or Other is selected from the Status list, provide the verbatim reason. | DSTERM | DSTERM |
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| 6 | Will the subject continue into the next epoch? | Continue | Record if the subject will be continuing to the next study period of this study. |
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| NOT SUBMITTED | (NY) | No; Yes |
| 7 | What is the next epoch the subject will continue to enter? | Next Epoch | Record the planned subsequent study epoch in which the subject intends to participate. |
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| NOT SUBMITTED | (EPOCH) | PRODUCT EXPOSURE; FOLLOW-UP;. |
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