This is an example CRF used to collected dispostion at the end of each epoch of a trial. Additionally, the CRF is used to collect information on the next epoch entered for adminstrative reason and this data is not submitted.
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| title | CDASH DS Metadata Specifications |
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| Metadataspec |
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| Order | Question Text | Prompt | Case Report Form Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList 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. | Text | 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. | Text | 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 format. If the subject did not complete the study or study period, record the date that the subject discontinued. | Date | 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. | Text | 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. | Text | 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. | Text |
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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. | Text |
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| NOT SUBMITTED | (EPOCH) | PRODUCT EXPOSURE; FOLLOW-UP. |
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