Disposition Example 1

This is an example CRF used to collect the protocol milestone, and informed consent.

Example CRF: Protocol milestones (e.g., informed consent)

	Disposition Category DSCAT DSCAT="PROTOCOL MILESTONE" where DSDECOD and DSTERM="INFORMED CONSENT OBTAINED" Hidden/pre-populated	PROTOCOL MILESTONE <DSCAT codelist>
Record the date of informed consent as defined in the protocol and/or CRF completion instructions using this format (DD-MON-YYYY).	What was the informed consent date? DSSTDAT DSSTDTC	_ _ / _ _ _ / _ _ _ _
Record the time (as complete as possible) of informed consent as defined in the protocol and/or CRF completion instructions.	What was the informed consent time? DSSTTIM DSSTDTC	_ _ : _ _ : _ _

CDASH Variable	Order	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Value	SDTMIG Target Mapping	Controlled Terminology Code List Name	CRF Implementation Notes	Pre-Populated Value	Query Display	Hidden
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					qtext
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					qtext

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

	Disposition Category DSCAT Hidden/pre-populated	DISPOSITION EVENT <DSCAT codelist>
Select the trial epoch for which disposition is being recorded.	Epoch EPOCH	SCREENING TREATMENT FOLLOW-UP <EPOCH codelist>
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.	Completion/Discontinuation Date DSSTDAT DSSTDTC	_ _ / _ _ _ / _ _ _ _
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).	Completion/Discontinuation Time DSSTTIM DSSTDTC	_ _ : _ _ : _ _
Document the subject's status for the study or trial period. If the subject discontinued prematurely, record the primary reason for discontinuation.	What was the subject's status? DSDECOD	COMPLETED ADVERSE EVENT DEATH LACK OF EFFICACY LOST TO FOLLOW-UP NON-COMPLIANCE WITH STUDY DRUG PHYSICIAN DECISION PREGNANCY PROTOCOL DEVIATION SITE TERMINATED BY SPONSOR STUDY TERMINATED BY SPONSOR WITHDRAWAL BY SUBJECT OTHER <NCOMPLT codelist>
If Adverse Event, Death, Protocol Deviation or Other is selected from the Status list, provide the verbatim reason.	Specify DSTERM	_________________
Record if the subject will be continuing to the next trial period of this study.	Will the subject continue? DSCONT SUPPDS.QVAL when SUPPDS.QNAM= "DSCONT" and SUPPDS.QLABEL="Subject Continue".	No Yes <NY codelist>
Record the planned subsequent trial epoch in which the subject intends to participate.	What is the next epoch the subject will continue to enter? DSNEXT Not Submitted	TREATMENT FOLLOW-UP <EPOCH codelist>

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
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; TREATMENT; 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
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
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; LACK OF EFFICACY; LOST TO FOLLOW-UP; NON-COMPLIANCE WITH STUDY DRUG; PHYSICIAN DECISION; PREGNANCY; PROTOCOL DEVIATION; SITE TERMINATED BY SPONSOR; STUDY TERMINATED BY SPONSOR; WITHDRAWAL BY SUBJECT; OTHER			radio
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					prompt
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			radio
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)	TREATMENT; FOLLOW-UP;

This is an example of an SDTM dataset used to represent the data collected on the above example CRFs.

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.

ds.xpt

Row	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	DSSCAT	EPOCH	DSDTC	DSSTDTC
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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Disposition Example 1