| Observation Class | Domain | Data Collection Scenario | Implementation Options | Order Number | Collection Variable | Collection Variable Label | DRAFT Collection Definition | Question Text | Prompt | Data Type | Collection Core | Case Report Form Completion Instructions | Tabulation Target | Mapping Instructions | Controlled Terminology Codelist Name | Subset Controlled Terminology/CDASH Codelist Name | Implementation Notes |
| Events | DS | PROTOCOL MILESTONE/OTHER EVENT | N/A | 1 | STUDYID | Study Identifier | A unique identifier for a study. | What is the study identifier? | [Protocol/Study] | Char | HR | N/A | STUDYID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included in the database or populated during tabulation dataset creation. |
| Events | DS | PROTOCOL MILESTONE/OTHER EVENT | N/A | 2 | SITEID | Study Site Identifier | A unique identifier for a site within a study. | What is the site identifier? | Site (Identifier) | Char | HR | N/A | DM.SITEID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. EDC: This should be prepopulated. |
| Events | DS | PROTOCOL MILESTONE/OTHER EVENT | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study. | What [is/was] the (study) [subject/participant] identifier? | [Subject/Participant] (Identifier) | Char | HR | Record the identifier for the subject. | DM.SUBJID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain. |
| Events | DS | PROTOCOL MILESTONE/OTHER EVENT | N/A | 4 | DSCAT | Category for Disposition Event | A categorization of the disposition events, which is used to distinguish between disposition events, protocol milestones, and other events. | What was the category of the disposition? | [Disposition Category] | Char | HR | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. | DSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (DSCAT) | N/A | This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. In this implementation scenario, DSCAT="PROTOCOL MILESTONE" or "OTHER EVENT". |
| Events | DS | PROTOCOL MILESTONE/OTHER EVENT | N/A | 5 | DSSCAT | Subcategory for Disposition Event | A sub-division of the DSCAT values based on user-defined characteristics. | What was the subcategory of the disposition? | [Disposition Subcategory]; NULL | Char | O | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. | DSSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. DSSCAT can only be used if there is an DSCAT and it must be a subcategorization of the Protocol Milestone or Other Event. |
| Events | DS | PROTOCOL MILESTONE/OTHER EVENT | N/A | 6 | EPOCH | Epoch | Trial Epoch (e.g., 'SCREENING', 'RUN-IN') for which subject disposition is being collected. | What is the trial period for this disposition event? | Trial Period | Char | R/C | Check the [epoch, or insert more appropriate wording] for which disposition event is being recorded. | EPOCH | Maps directly to the tabulation variable listed in the Tabulation Target column. | (EPOCH) | N/A | If protocol milestones or other events are collected more than once in the study, EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as part of the title of the page; however, some companies have a standard CRF module that includes a pick-list of epochs. |
| Events | DS | PROTOCOL MILESTONE/OTHER EVENT | N/A | 7 | | Standardized Disposition Term | The standardized terminology of the disposition term. | [Applicant-defined] | [Applicant-defined] | Char | R/C | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. | DSDECOD | Maps directly to the tabulation variable listed in the Tabulation Target column. Both DSDECOD and DSTERM must be populated in the tabulation dataset. | (PROTMLST) (OTHEVENT) | N/A | Where DSCAT = "PROTOCOL MILESTONE", DSTERM contains the verbatim (as collected) and/or standardized text; DSDECOD uses the extensible controlled terminology codelist (PROTMLST). Where DSCAT="OTHER EVENT", DSDECOD uses the extensible controlled terminology codelist (OTHEVENT). |
| Events | DS | PROTOCOL MILESTONE/OTHER EVENT | N/A | 8 | DSTERM | Reported Term for the Disposition Event | The verbatim or pre-specified name of the disposition term. | [Applicant-defined] | [Applicant-defined] | Char | R/C | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.
| DSTERM | Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variables DSDECOD and DSTERM must be populated in the tabulation dataset. | N/A | N/A | When defining protocol milestones or other events, applicants may populate DSTERM and DSDECOD with the same value (e.g., INFORMED CONSENT OBTAINED). DSTERM may also be populated with a verbatim term, which is then standardized in DSDECOD. |
| Events | DS | PROTOCOL MILESTONE/OTHER EVENT | N/A | 9 | | Disposition Event Start Date | The date of the specified protocol milestone (e.g., informed consent) represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the [protocol milestone/other event name] (start) date? | [Protocol Milestone/Other Event Name] (start) Date | Char | R/C | Record the date of the protocol milestone/other event as defined in the protocol and/or CRF completion instructions, using this format (DD-MON-YYYY). | DSSTDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable DSSTDTC in ISO 8601 format. | N/A | N/A | Applicants should define in the protocol and/or CRF completion instructions the criteria for completion of each protocol milestone/other event and its associated (start) date. |
| Events | DS | PROTOCOL MILESTONE/OTHER EVENT | N/A | 10 | DSSTTIM | Disposition Event Start Time | The time of the specified protocol milestone (e.g., informed consent) or other event, represented in an unambiguous time format (e.g., hh:mm:ss). | What was the [protocol milestone/other event name] (start) time? | [Protocol Milestone/Other Event Name] (start) Time | Char | O | Record the time (as complete as possible) as defined in the protocol and/or CRF completion instructions. | DSSTDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable DSSTDTC in ISO 8601 format. | N/A | N/A | Applicants should define in the protocol and/or CRF completion instructions the criteria for completion of each protocol milestone/other event (start) time. Collecting the time of the event is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail. |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 1 | STUDYID | Study Identifier | A unique identifier for a study. | What is the study identifier? | [Protocol/Study] | Char | HR | N/A | STUDYID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during tabulation dataset creation. |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 2 | SITEID | Study Site Identifier | A unique identifier for a site within a study. | What is the site identifier? | Site (Identifier) | Char | HR | N/A | DM.SITEID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. EDC: This should be prepopulated. |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study. | What [is/was] the (study) [subject/participant] identifier? | [Subject/Participant] (Identifier) | Char | HR | Record the identifier for the subject. | DM.SUBJID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain. |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 4 | DSCAT | Category for Disposition Event | A categorization of the disposition events which is used to distinguish between disposition events, protocol milestones, and other events. | What was the category of the disposition? | [Disposition Category] | Char | HR | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. | DSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (DSCAT) | N/A | This would most commonly be a heading on the CRF or screen, not a question to which the site would provide an answer. This is used to distinguish a DISPOSITION EVENT, a PROTOCOL MILESTONE, or an OTHER EVENT. In this implementation scenario, DSCAT="DISPOSITION EVENT" |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 5 | DSSCAT | Subcategory for Disposition Event | A sub-division of the DSCAT values based on user-defined characteristics. | What was the subcategory of the disposition? | [Disposition Subcategory]; NULL | Char | O | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. | DSSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. DSSCAT can only be used if there is an DSCAT, and it must be a subcategorization of the Disposition event. |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 6 | EPOCH | Epoch | Trial epoch (e.g., 'SCREENING', 'RUN-IN') for which subject disposition is being collected. | What is the trial period for this disposition event? | Trial Period | Char | R/C | Check the [epoch, or insert more appropriate wording] for which disposition is being recorded. | EPOCH | Maps directly to the tabulation variable listed in the Tabulation Target column. | (EPOCH) | N/A | If disposition events are collected more than once in the study, EPOCH may be needed to differentiate them. Typically, the trial epoch will be pre-printed on the CRF as part of the title of the page; however, some companies have a standard CRF module that includes a pick-list of epochs. |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 7 | DSDECOD | Standardized Disposition Term | The standardized terminology of the disposition term that describes whether a subject completed the study or a portion of a study (epoch), or the reason they did not complete. | What was the subject's status (at the EPOCH/study specific time frame)? | Status (at the EPOCH/study specific time frame) | Char | R/C | Document the subject's status at [insert text corresponding to the selected trial epoch/study specific time frame]. If the subject discontinued prematurely, record the primary reason for discontinuation. | DSDECOD | Maps directly to the tabulation variable listed in the Tabulation Target column. Both DSDECOD and DSTERM must be populated in the tabulation datasets. If DSTERM was collected as an "Other, Specify" free text, populate DSTERM with the free text and populate DSDECOD with the applicant-defined standardized text. If DSDECOD was collected with no free text, populate DSTERM and DSDECOD in the tabulation dataset with the DSDECOD value that was collected. | (NCOMPLTTNCOMPLT) | N/A | DSDECOD can be used as the standardized coded list with DSTERM used to capture any "Specify, Other" information, or DSDECOD can be used on its own. For applicant- and/or study-specific reasons for discontinuation, it is recommended that these reasons be pre-printed on the CRF, as subcategories of the appropriate standardized DSDECOD item. However, it is recommended to limit the use of applicant and study-specific reasons in order to promote consistent use of terminology and permit the combination of data across multiple applicants. Either DSTERM or DSDECOD must be on the CRF. Both may be used if DSTERM is used as a Specify, Other field. |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 8 | DSTERM | Reported Term for the Disposition Event | The verbatim or pre-specified name of the event. The reported or pre-specified name for how a subject completed the study or a portion of a study (epoch), or the reason they did not complete. | What was the subject's status?; If [DSDECOD], specify | [Status]; [Specify] | Char | R/C | Document the subject's status at [insert text corresponding to the selected trial epoch]. If the subject discontinued prematurely, record the primary reason for discontinuation. (Or, if used with a DECOD list) If Other is selected from the Status list, provide the verbatim reason. | DSTERM | Maps directly to the tabulation variable listed in the Tabulation Target column. The tabulation variables DSDECOD and DSTERM must be populated in the tabulation dataset. If DSTERM was collected as an "Other, Specify" free text, populate the tabulation variable DSTERM with the free text and populate DSDECOD with the applicant-defined standardized text. If DSDECOD was collected with no free text, populate DSTERM and DSDECOD in the tabulation dataset with the DSDECOD value that was collected. | N/A | N/A | If used with a DECOD list, free-text description of the subject's "Other" status. DSTERM is the verbatim term for subject status when Other is selected from the DSDECOD code list. This field would only be used with the prompt and completion instructions provided as a Specify, Other field in conjunction with DSDECOD. DSTERM may be used by itself when no code list is provided for DSDECOD on the CRF. Either DSTERM or DSDECOD must be on the CRF. DSTERM is required in the tabulation dataset. |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 9 | | Disposition Event Start Date | The date of the specified disposition event (e.g., study completion or discontinuation), represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the disposition event date? | Disposition Event Date | Char | R/C | Record the date of disposition event as defined in the protocol and/or CRF completion instructions using this format (DD-MON-YYYY) | DSSTDTC | This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable DSSTDTC in ISO 8601 format. | N/A | N/A | Applicants should define in the protocol and/or CRF completion instructions the criteria for completion of each epoch for which a Disposition CRF will be provided. Define also the date of completion or discontinuation. Only collect the date of the disposition event once. |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 10 | DSSTTIM | Disposition Event Start Time | The time of the specified disposition event (e.g., study completion or discontinuation), represented in an unambiguous time format (e.g., hh:mm:ss). | What was the disposition event time? | Disposition Event Time | Char | O | Record the time (as complete as possible) that the subject completed the study or portion of the study as defined in the protocol and/or CRF completion instructions. If the subject did not complete the study or portion of the study, record the time (as complete as possible) as defined in the protocol and/or CRF completion instructions. | DSSTDTC | This does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable DSSTDTC in ISO 8601 format. | N/A | N/A | Applicants should define in the protocol and/or CRF completion instructions the criteria for completion of each epoch for which a Disposition CRF will be provided. Define also the date of completion or discontinuation. Collecting the time of completion or discontinuation is only appropriate if it can be realistically determined and if there is a scientific reason for needing to know this level of detail. Typically, it is not recommended that a time be collected unless the subject is under the direct care of the site at the time of the event. Only collect the time of completion or discontinuation on the Disposition CRF module if the same information is not being collected on another CRF module. |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 11 | DTHDAT | Death Date | Date of death for any subject who died. | What [is/was] the subject's date of death? | Death Date | Char | O | Record the date of death | DM.DTHDTC | This field does not map directly to an tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable DTHDTC in ISO 8601 format. | N/A | N/A | The CDASH model defines Death Date as a timing variable; this is not included as a timing variable in the SDTM. It may be collected on any CRF deemed appropriate by the applicant, but should only be collected once. The tabulation variable DTHDTC is mapped to the DM domain during the tabulation dataset creation process. The tabulation variable DM.DTHFLG is not a collection variable, but is populated during the tabulation dataset creation process. Death Date may also be mapped to other tabulation domains (e.g., DS) as deemed appropriate by the applicant. |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 12 | DSCONT | Subject Continue | The plan for subject continuation to the next phase of the study or another study at the time of completion of the CRF. | Will the subject continue? | Subject Continue | Char | O | Record if the subject will be continuing to [the next phase of this study/related study] (applicant to specify as appropriate). | SUPPDS.QVAL | This information could be represented in a SUPPDS dataset as the value of SUPPDS.QVAL when SUPPDS.QNAM= "DSCONT" and SUPPDS.QLABEL="Subject Continue". | (NY) | N/A | Applicants should specify the next phase of the study or the related study on the CRF. Typically this is a prompt to aid in monitoring and data cleaning, and usually not represented in a SUPPDS dataset. |
| Events | DS | STUDY PARTICIPATION DISPOSITION EVENT | N/A | 13 | DSNEXT | Next EPOCH | Identifies the study epoch or new study in which the subject will participate. | What is the next [epoch/period/study/trial] the subject will [continue to/enter/enroll]? | Next [Epoch/Period/Study/Trial] | Char | O | Record the planned subsequent [study epoch/study] in which the subject intends to participate. | N/A | Applicant-defined tabulation mapping. | N/A | N/A | Applicants should specify the next phase of the study or the related study on the CRF. The data are to be used to aid in monitoring and data cleaning. No specific tabulation dataset mapping rules are provided because the mapping depends on the situation (e.g., next epoch, next trial). Per applicant decision, plans to enter the next epoch within a study may be included in the tabulation datasets (e.g., SE). Actual subject entry into the next study is represented as part of Trial Design datasets of that study. |